You are using an unsupported browser.
Some features of this site may not function properly. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge.

Career Opportunities

Headquarters – Waltham, MA

Expand All

Repligen has range of single-use cell retention systems that are continuously being refined and updated to meet market needs. We are seeking an experienced Research Application Scientist I within the research and development group focusing on upstream technologies for cell culture processes. The group is responsible for application research support for new product developments within Repligen.    

Primary Job Responsibilities

  • Performing application-oriented cell culture experiments for new and existing Repligen products. Laboratory activities will include fed-batch and perfusion processes using mammalian cell lines and optimizing clarification methods
  • Analyzing and trouble-shoot cell culture processes by monitoring cell growth, viability, protein productivity and other cell culture metabolites
  • Proficient in developing protocols and reports for processes in shake flasks and stirred tank and single-use bioreactors using ATF/TFF and other perfusion systems
  • Knowledgeable in protein quality and purification projects using chromatographic separation methods
  • Designing experimental investigations, scale-up process, analyzing experimental data, new findings, and literature review, submitting technical reports, and giving presentations internally and at scientific conferences
  • Designing and executing new application studies for market intelligence or to complement Repligen’s product lines based on feedback from the intra and interdepartmental discussions
  • Should be able to deliver scientific guidance and subject matter expertise for upstream processes
  • Working with other departments including manufacturing, project management and sales to accomplish individual and company objectives 

Minimum Requirements

  • B.S Degree in chemical engineering, biochemistry, or applicable field with at least 3 years or MS with at least 1-2 years of industrial experience in a process or applications development setting
  • Extensive understanding in biological process sciences, upstream process development including aseptic techniques, cell culture processes, and protein analytics
  • Experienced hands-on work setting up lab and pilot scale bioreactors, culturing cells and optimizing feeding and perfusion strategies
  • Demonstrated experience in the design of experiments (DoE), strong analytical and problem-solving skills to understand and to contribute with novel solutions
  • The ability to work independently and in a team setting
  • Excellent oral and written communication abilities and strong interpersonal skills to communicate with internal and external team members

Additional Qualifications

  • Additional experience with gene therapy applications and viral vaccines would be a plus
  • Experience with continuous bioprocessing desirable but not necessary
  • Previous experience with hollow fiber membranes, determining critical flux, shear and TMP measurements 

Apply

Repligen is looking for an experienced Manufacturing Scheduler that will be responsible for the daily scheduling of OPUS work centers and ensuring production schedules meet or exceed customer delivery expectations in a low volume / mixed model manufacturing environment. The Master Scheduler should be proficient in the use of MRP/ERP systems, Finite Forward Scheduling and Theory of Constraints with experience implementing Kanban / Heijunka replenishment tools. Other skills include use of and maintenance of master data in ERP/MRP systems.The goal is to ensure the smooth and cost-efficient flow of our production operations.

Responsibilities

  • Coordinate manufacturing workflow for multiple projects simultaneously
  • Plan and prioritize operations to ensure maximum performance and minimum delay
  • Determine manpower, equipment, and raw materials needed to cover production demand
  • Monitor jobs to ensure they will finish on time and within budget
  • Address issues when they arise aiming for minimum disruption
  • Obtain output information (number of finished products, percentage of defectives etc.)
  • Prepare and submit status and performance report
  • Collaborate with quality control, project management, production supervision, warehouse, purchasing, and other staff
  • Develop and manage Production Schedules to maximize the company's throughput, efficiency and effectiveness and communicate demand and changes to Production Team daily
  • Optimize the flow of raw materials and Work in Process throughout the plant to minimize inventory levels, minimize transaction volumes and continuously improve efficiency in relation to production schedules
  • Synchronizes production schedules between departments
  • Follow-up that schedules are being followed and communicate with planning
  • Responsible to identify and trigger modifications needed to Bills of Materials and Routes and lead-times and other master data to keep the finite forward scheduling system effective and efficient
  • Proactively identify, communicate and de-conflict scheduling issues
  • Monitors capacity levels for each resource and recommends equipment and staffing level changes to support growth trends
  • Works with Plant Manager to justify and obtain approval for appropriate changes
  • Keeps Plant Manager apprised of issues and seeks guidance as appropriate • Assumes additional responsibilities as needed
  • Supports safety and quality goals throughout the facility
  • Support continuous improvement projects
  • Provide reports/metrics to management as required

Requirements/Experince

  • Excellent knowledge of production planning and quality control principles
  • Experience in MRP (Manufacturing resource planning)
  • Working knowledge of MS Office and ERP systems, advanced Excel skills preferred
  • Strong organizational and problem-solving skills
  • Excellent communication abilities

Qualifications

  • Bachelor's degree or equivalent experience in Supply Chain, Business, or Engineering
  • 5+  years of experience hands-on Production Planning and Master Scheduling with previous experience developing Master Scheduling methods and work-flows.
    • Experience using lean manufacturing pull systems. level loading, and capacity planning tools preferred • Excellent communicator with the ability to be both deeply analytical and provide executive level messaging and communications
    • Super-user of Excel (macros, algorithms, SQL statements), and Infor Syteline
    • Ability to read an engineering drawing and bill of materials
    • Ability to work under pressure, meet deadlines and work independently with little supervision.
  • Ability to develop constructive and cooperative working relationships and interdepartmental group commitments to effectively achieve production goals and objectives

Apply

This position is for a Manufacturing Associate in the Repligen XCell™ ATF manufacturing group. Operator will be responsible for all aspects of manufacture, including electronic controller assembly and testing, pneumatic and vacuum solenoid valve assembly and test, system pressure and vacuum testing, system flow calibration, product evaluation, and software test. This person will also be responsible for documenting all work in production batch records; operation of laboratory equipment (including pumps, power tools, hand tools, pressure tanks, and various gauges/sensors) and operation of manufacturing equipment.

This team will be moving to our Marlboro facility later in 2019.

Responsibilities: 

  • Operates production equipment as it relates to manufacturing operations
  • Maintains records to comply with regulatory requirements. Documents all work on batch records according to Good Manufacturing practices. Performs batch record review as required by Production management
  • Completes ISO9001 QMS documentation, including Batch Records, Forms, Deviation reports, Failure Investigations and Change Controls
  • May be involved in identifying root causes to production issues
  • Responsible for completion of any Repligen Bioprocessing Manufacturing tasks related to meeting production goals
  • Able to work independently, to meet all manufacturing objectives
  • May be asked to participate in other manufacturing operations, as required by management such as inventory control, packaging, and assisting in development activities

Qualifications: 

  • 3-5 years relevant technical experience
  • Experience and/or willingness to work in a certified ISO class 7 biopharma manufacturing clean room setting is a must
  • Candidates with electro mechanical aptitude preferred
  • The ideal candidate would be conscientious and self-motivated with a proven track record as a quick learner

APPLY

The Label Manager is a result oriented, detail driven member of a growing team with a technical-requirements, sustainability-minded and continuous improvement approach. S/he will lead and support labeling development strategies for new products, product line extensions and existing product updates in a fast-paced, high-growth environment. Responsibilities include development and standardization of on-product and on-package labeling with all elements required for safety, regulatory compliance and optimal customer experience for projects of moderate to high complexity across multiple company sites. Manages the development, review, approval and maintenance of regulatory-compliant labeling documents and packaging component labeling.

Key Responsibilities:

  • Drive labeling projects and collaborate with R&D colleagues early in new product development projects to ensure robust and on-time product launches through requirements definition, label design, prototype development, barcode scan testing and functional testing
  • Manage label design and print on-demand file changes to ensure they are systematically and thoroughly analyzed through proper justification and/or data collection for verification of performance requirements
  • Lead and support cross-functional teams with R&D, engineering, project management, quality, manufacturing, product management, supply chain, regulatory and marketing to ensure project success
  • Monitor the worldwide labeling regulation changes relevant to Repligen products; develop and maintain associated labeling SOPs and work instructions
  • Generate and support preparation of label related specifications, first article inspection (FAI) criteria, performance studies, test plans, test protocols, test reports, risk assessments and other relevant project/process documentation
  • Trouble-shoot and resolve new and existing labeling issues involving designs, content, materials, and processes through creative, timely and cost-effective solutions
  • Analyze engineering drawings and specifications of products to determine physical characteristics, special handling/environmental/safety concerns, and types of materials and design features required for label development
  • Define label testing and regulatory compliance requirements; Manage compliance programs internally while utilizing external expert support services as required
  • Summarize, analyze, draw conclusions and make recommendations based on test results
  • Drive investigative bench study experiments for labeling design as required
  • Work with external suppliers to design, specify and qualify individual labeling components and labels that are critical to overall packaging systems
  • Create new and revise existing labeling print files for packaging components and systems based on specifications and standards
  • Partner with Product Development and Supply Chain to identify primary and secondary labeling vendors for current and new products
  • Support strategic plans for process and plant improvements related to labeling to increase efficiency and control costs
  • Partner with Quality and Regulatory colleagues to ensure compliance with regulatory authority guidance/requirements for labels and labeling operations
  • Train staff on new labeling processes or procedures as required or applicable  

Knowledge, Skills Abilities:

  • Bachelor’s Degree. Direct regulatory experience can offset education requirements
  • Three to five years of Regulatory Labeling experience in life/bioscience or biotechnology environment
  • In-depth knowledge of the labeling process, industry practices, product development processes, label printers and packaging manufacturing processes. Familiar with policies and operating procedures related to medical safety regulatory, corporate and worldwide Regulatory Agencies and/or governing bodies
  • Experience with OSHA, REACH/CLP, GHS, FCC, UL, CE safety labeling standards and other relevant regulatory requirements
  • Demonstrable proficiency in BarTender label software is a plus
  • Ability to work independently to plan and schedule activities necessary to meet project timelines
  • Understanding of quality system controls (e.g. user needs, design inputs/outputs, verification/validation, etc.)
  • Strong communication skills (oral and written)
  • Ability to manage multiple projects simultaneously
  • Demonstrated problem solving capability
  • Strong attention to detail; ability to manage multiple projects and timelines effectively
  • Demonstrated ability to work independently and lead cross-functional teams to meet organizational goals
  • Ability to work effectively with all levels of associates and management
  • Adaptable to change and able to work successfully in fast-paced environment
  • Ability to travel to other Repligen global locations as required

Apply

This position is in Repligen’s ELISA group. The successful candidate will be responsible for the manufacture of ELISA kits and its components as well as in-process testing. The individual must be able to follow oral and written instructions accurately and complete tasks in a timely manner. Experience working in a GMP/ISO/document-controlled environment would be beneficial. Attention to detail and the ability to work in a team environment are essential. Candidates must be willing and able to learn new manufacturing processes as the company grows. 

Responsibilities

  • Plate coating, conjugate production, buffer preparation and kit assembly
  • Dispensing, capping, labeling and packaging of reagents
  • Working with automated systems
  • Ensure all ELISA Manufacturing operations are carried out in accordance with the Repligen ISO 9001 Quality Management System
  • Ability to analyze and interpret data and results
  • Maintain an appropriate level of housekeeping and safety within the ELISA Lab
  • Ensure all manufacturing processes are carried out according to approved batch records and SOPs
  • Complete and review batch records for accuracy in a timely manner  

Qualifications

  • Requires an AS/BS or equivalent with 1- 2 + years of relevant work experience
  • Experience working within ISO9001 and/or GMP documentation and quality systems
  • Experience in aseptic techniques and working in a laboratory setting
  • Willing to work overtime as required
  • Able to lift 25 lbs
  • Proficient in Microsoft Excel and Word
  • ERP knowledge is preferred but not required
  • Excellent verbal and written communication  

Apply

We are seeking an experienced Product Manager to lead the filtration systems/products that include high-performance hollow fiber membranes and flat sheet cassettes used for critical bioprocessing applications. Systems will have manual/semiautomatic and fully automatic functionalities including single use instrumentation and controls. Experienced in the science and art of membrane manufacturing, Repligen is setting the standards in tangential flow filtration solutions for concentration and diafiltration application areas.

The Product Manager will be responsible for driving and ensuring the long term success of this business. This will be a “hands-on” operationally focused position managing the order lifecycle process from quoting to delivery.  Working externally with the sales team, this position will be responsible for driving TFF Technology adoption and driving the internal organization to improve lead time and expand the product range. The successful candidate will:

  • Derive strategy and tactics, and manage the product life cycle to ensure business growth and strong customer satisfaction
  • Support the global Sales organization, providing effective product positioning, sales tools, training, competitive analysis and in-field support as needed
  • Analyze and respond to technical questions related to product use and performance, tangential flow filtration, product quality, and service features
  • Derive forecast to ensure accurate demand planning, product build and revenue attainment
  • Be responsible for assessing business performance through KPI tracking.
  • Collaborate with sales and engineering to develop new or improve existing products based on VOC
  • Work with Operations and Customer Service to ensure on time delivery of products and services 
  • Drive resolution of customer inquiries and complaints with required internal functions including Quality, Supply Chain, Manufacturing and R&D
  • Liaise with Marketing to develop effective product collateral and campaigns

Qualifications: 

  • A BS degree or higher in an engineering or science discipline, with MBA is preferred
  • A minimum of 10 years of experience in commercial product management, business management or sales and marketing
  • Experience with hardware/equipment and filtration operations in bioprocessing is preferred
  • Customer facing experience and the ability to build mutually beneficial, trusting relationships with internal and external stakeholders
  • Strong attention to detail with excellent verbal and written communication skills
  • Ability to take initiative, hold team members accountable for deliverables, and obtain support across departments
  • Strategic, tactical and analytical thinking
  • Ability to travel globally, up to 25%
  • Proficient in MS Office Suite (Word, Excel, Powerpoint, Project and Visio)

APPLY

We are seeking an experienced Product Manager to lead the filtration systems/products that include high-performance depth filters and related systems used for critical bioprocessing applications. Systems will be semiautomatic and fully automatic functionalities including single use instrumentation and controls. Experienced in the science and art of membrane manufacturing, Repligen is setting the standards in tangential flow filtration solutions for concentration and diafiltration application areas. The Product Manager will be responsible for driving and ensuring the long term success of this business. This will be a “hands-on” operationally focused position managing the order lifecycle process from quoting to delivery. Working externally with the sales team, this position will be responsible for driving TFDF™ Technology adoption and driving the internal organization to support and expand the product range. The successful candidate will:

  • Derive strategy and tactics, and manage the product life cycle to ensure business growth and strong customer satisfaction
  • Support the global Sales organization, providing effective product positioning, sales tools, training, competitive analysis and in-field support as needed
  • Analyze and respond to technical questions related to product use and performance, tangential flow depth filtration, product quality, and service features
  • Derive forecast to ensure accurate demand planning, product build and revenue attainment • Be responsible for assessing business performance through KPI tracking
  • Collaborate with sales and engineering to develop new or improve existing products based on VOC
  • Work with Operations and Customer Service to ensure on timely delivery of products and services
  • Drive resolution of customer inquiries and complaints with required internal functions including Quality, Supply Chain, Manufacturing and R&D
  • Liaise with Marketing to develop effective product collateral and campaigns  

Qualifications

  • A BS degree or higher in an engineering or science discipline, with MBA is preferred
  • A minimum of 10 years of experience in commercial product management, business management or sales and marketing
  • Experience with hardware/equipment and filtration operations in bioprocessing is preferred
  • Customer facing experience and the ability to build mutually beneficial, trusting relationships with internal and external stakeholders
  • Strong attention to detail with excellent verbal and written communication skills
  • Ability to take initiative, hold team members accountable for deliverables, and obtain support across departments
  • Strategic, tactical and analytical thinking
  • Ability to travel (including global travel), up to 25%
  • Proficient in MS Office Suite (Word, Excel, PowerPoint, Project and Visio)

Apply

This role reports directly to the Assistant Controller and is a proven professional, responsible for all technical and operational aspects of cost accounting for the company. This includes a hands-on knowledge of purchasing and manufacturing, intimate working knowledge of ERP systems, history of driving process and controls improvement and the ability to work effectively in a fast moving, cross-functional, environment.

The Senior Cost Accountant works closely with manufacturing, inventory control, purchasing, facilities, quality and other parts of the organization and is responsible for the product standard cost setting and maintenance, monthly variance analysis, gap resolution, financial close and operations related financial reporting. 

Responsibilities:

  • Manage monthly, quarterly and annual close processes, including the preparation of COGS and inventory journal entries, account reconciliations, accruals, excess and obsolete inventory reserve calculations and intercompany transactions
  • Prepare monthly, quarterly and annual product gross margin analysis, including variance commentary and identification of process and cost saving opportunities
  • Perform or support various inventory transactional processing in SAP (i.e. standard cost updates, scrapping, freight allocations, etc.)
  • Monitor / report on manufacturing variances (Material, WIP, Labor, PPV, etc.)
  • Monitor balance sheet accounts and prepare detailed account reconciliations for deferred COGS, capitalized variances, E&O reserves, etc.
  • Monitor inventory-related SOX controls and establish and perform self-testing as required
  • Coordinate quarterly physical inventory process and participate in loading counts into SAP
  • Partner with supply chain to design and implement a cycle count program, effective enough to eliminate quarterly physical inventory counts
  • Calculate profit-in-inventory eliminations of intercompany inventories held locally and at global selling offices
  • Work closely with international locations, overseeing global inventory balances
  • Partner with financial planning and analysis and operations teams to coordinate budgeting and forecasting, including materials, labor and overhead expense forecasting, standard cost setting, etc.
  • Provide hands on implementation support for purchase accounting, acquisition integrations, etc., as required
  • Perform special accounting analysis, reporting and projects, as requested

Qualifications:

  • Bachelor's degree in Accounting, with MBA or CPA preferred
  • Significant cost accounting experience with mid or large sized company – Preferred standard costing
  • Very strong attention to detail and professional curiosity
  • Strong Excel skills (comfortable with pivot tables/ large data manipulation); SAP experience a plus
  • Understanding of US GAAP and SOX internal controls related to inventory reporting
  • Experience in researching, developing and implementing accounting policies and procedures
  • Excellent analytical and technical accounting skills
  • Ability to organize and manage multiple priorities; deadline oriented
  • Skilled in root cause, corrective action activities
  • Excellent communication and inter-personal skills, both written and verbal

Apply

Responsible for performing the physical tasks involved in the shipping, receiving, storing, and distributing of products, materials, parts, supplies and equipment. Unpacks and checks goods received against purchase orders or invoices, maintains records of received goods, rejecting unsatisfactory items where necessary. Pulls and fills orders. May use (but not limited to) power equipment such as a forklift, hand tools, and other devices operated in a warehouse environment. Prepares and maintains records of merchandise shipped. Posts weights and shipping charges and prepares goods for final shipment. Examines stocks and distributes materials in inventory and on manufacturing lines. May prepare kitting packages for assembly production. 

Key Responsibilities:

  • Loads and unloads product to and from delivery vehicles and designated storage areas
  • Reads production schedule, customer orders, work orders, shipping orders, or requisitions to determine items to be moved, gathered, or distributed
  • Conveys materials and items from receiving or production areas to storage or other designated areas
  • Sorts and places materials or items on racks, shelves, or in bins according to predetermined sequence, such as: size, type, style, color, or product code
  • Fills requisitions, work orders, or requests for materials, tools, or other stock items and distributes items to production workers or assembly line
  • Assembles customer orders from stock and places orders on pallets or shelves, or conveys orders to packing station or shipping department
  • Marks materials with identifying information
  • Opens bales, crates, and other containers
  • Records amounts of materials or items received or distributed
  • Weighs or counts items for distribution to ensure conformance to company standards
  • Arranges stock parts in specified sequence for assembly by other workers
  • Enters and maintains inventory records in the computer
  • Prepares parcels for mailing
  • Cleans warehouse area
  • Other duties as required and assigned 

Knowledge, Skills Abilities:

  • High school diploma or GED (General Education Diploma) equivalency
  • Minimum 2 to 4 years of related experience
  • Ability to perform these operations using units of American currency and weight measurement, volume, and distance
  • Ability to complete duties with standardized situations with only occasional or no variables
  • M/S Dynamics is a +  

Apply

Essential Duties and Responsibilities:

  • Performs final testing of finished OPUS® pre-packed chromatography columns and documents results for product release, and assists with any additional OPUS® related QC requirements
  • Performs in-process concentration analysis by UV
  • Performs sample preparation and testing for FTIR analysis in support of the OPUS® manufacturing
  • Carries out monitoring of controlled environments and records data for trend analysis
  • Conducts final product testing of all materials manufactured at Repligen
  • Preparation of buffers for running SDS-PAGE gels and HPLCs
  • Microbial: Bioburden/ Endotoxin testing
  • BCA, preferable
  • Support stability testing
  • Supports Validation studies
  • Collection of RODI water sampling and testing
  • Perform the monitoring of controlled environments
  • Support/Initiate/ Approve Investigations for Deviations, CAPA, Change Control, OOS etc.
  • Support documentation review/ peer review (Batch Record Review)

Education and/or Work Experience Requirements:

  • Requires college level education in Biology or related field and 4-8 years’ experience in Quality Control laboratory or equivalent
  • Ability to work independently once training has been completed
  • High attention to detail applied to all aspects of daily activities
  • Ability to work efficiently in an ISO 9001 quality system with appropriate attention to detail in the performance of controlled procedures
  • Good understanding of the fundamentals of column chromatography
  • Experience or knowledge of FTIR
  • Familiarity with microbiology techniques such as aseptic handling of materials and working within a BioSafety Cabinet

Apply

This position is responsible for the leadership and management of the overall planning, development and execution of supply chain initiatives to support the goals, objectives, and expected financial results of Repligen. The Associate Director is focused on ensuring product is delivered on time and in full through both distributor and sales channels. The incumbent will define and implement business processes to support corporate objectives in the areas of safety, cost, quality, and delivery. The Associate Director is a dynamic service orientated leader who manages complex tasks independently in addition to leading cross-functional teams in a fast-paced environment.

Essential Functions

  • Advance the Supply Chain organization in developing appropriate business strategies including inventory strategy on existing items, new products, and product phase-outs, production schedule adherence, and capacity planning
  • Manage compliance to stock targets and implement corrective actions when out of alignment
  • Establish, monitor and share reports for global planning Key Performance Indicators. To include measures such as Days of Supply, Forecast Accuracy, Safety Stock Maintenance, and Line Item Fill Rate
  • Develops a cross functional SI&OP process leveraging industry best practices and improving long term demand visibility by conducting the necessary analysis and reporting
  • Champion Material Resource Planning system including evaluation of proposed changes, updating master data, and implementation of system upgrades
  • Use MRP analytics and creates customized metrics and reports to identify risks and opportunities in supply chain processes, including production scheduling, inventory forecasting, and supplier performance
  • Proactively anticipate and identifies supply chain risks and develops action and resolution plans
  • Establish and maintain effective communication channels to provide accurate information and communicates critical issues, gaps and constraints to management and production team
  • Recruit and develop staff to execute department functions; ensure effective utilization of resources through consistent performance management, mentorship, and rewards and recognition practices

Leadership/Teamwork/Contacts

The Associate Director of Planning has the primary responsibility for the delivery of product meeting internal and external customer expectations. The position requires strong analytical and persuasive skills. Management of the internal requirements is a key role of the position. Erroneous or mistimed decisions may cause critical delays or cost impact and may have an immediate effect on the company’s success. The job entails assessment of data and strong analytical decision making, superior leadership, interpersonal, organizational and team-building skills.

Education

  • Bachelors in Business or equivalent experience

Experience

  • 6-10 year’s business experience
  • SAP is a +
  • Skilled in using ERP, Microsoft Excel, Word, Power Point, Outlook

Apply

Marlborough, MA

Expand All

The automation engineer will report directly to a senior controls engineer and will be primarily responsible for the design, deployment, and maintenance of industrial computerized process control and monitoring products. You will also have responsibility for creation of new documentation and the maintenance of that documentation in an ISO regulated plant. The successful candidate will actively work with all levels of personnel from manufacturing to customers. Up to 20% travel in support of the service and customer requests.

Requirements:

  • Provide advanced level of technical automation support and troubleshooting
  • Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines
  • Lead engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, protocol review, and testing to meet end user requirements
  • Update or author system specifications, user requirements, functional requirements, and system design specifications
  • Generate and execute necessary testing and qualification protocols as related to the overall design and performance of automated process and monitoring equipment
  • Design, develop, and implement software/hardware improvements to automated process control products
  • Develop and execute test plans for software/hardware improvements
  • Provide guidance to Automation Personnel
  • May provide training or presentations on basic automation systems to field applications, service, and customers
  • Develop and draft standard operating procedures and automation engineering documents
  • Complete assigned work with some management or senior engineering staff oversight
  • Communicate effectively with engineering staff and cross functional departments

Education and/or Work Experience Requirements: ​​​​​

  • Advanced skills with programming and troubleshooting PLCs, HMIs, and computerized system design, installation, and support in a cGMP industrial setting
  • Expert in PLC/HMI logic programming and troubleshooting Allen-Bradley and Siemens products which involve the use of batch programming (S-88), data acquisition, and PID control
  • Demonstrated knowledge of electrical systems, instrumentation and controls
  • Strong knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility
  • Expertise in developing and editing Software Lifecycle Documentation, engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines
  • Strong understanding of bioprocessing equipment design principles and sanitary equipment design requirements
  • Strong written and verbal communication skills with ability to delegate tasks
  • Proficiency with standard business software is required (Word, Excel, etc.)
  • Able to balance changing priorities with increasing workload by making timely decisions
  • Able to interact with employees at all levels and cross functionally across multiple departments
  • Ability to manage and develop direct reports through mentoring and leadership
  • BS in Engineering or related field and 5 years of experience in the design and maintenance of process control systems and/or data acquisition systems
  • Equivalent relevant experience in the design and maintenance of process control systems and/or data acquisition systems may be considered in lieu of a degree
  • Specific knowledge of Allen-Bradley and Siemens control system products is requiredDirect experience in a pharmaceutical or biopharmaceutical manufacturing facility is preferred
  • *Level will be determined based on skills and related experience.*

Physical Requirements:

  • Must be capable of lifting 50 pounds routinely

Apply

The manufacturing associate will report directly to manufacturing director and will be primarily responsible for the assembly, test, and packaging of tangential flow filtration products in manufacturing. You will be working with assembly drawings, SOP’s, and batch records to record all pertinent data according to our ISO 900-2015 quality management system. The successful candidate will actively work with all levels of manufacturing personnel, product development, and planning. You will be responsible for the training other new employees as the group grows.

  • Mechanical assembly and testing of TFF systems per assembly drawings, SOP’s, and batch records
  • Point to point wiring, installation of cables, installation of software, and packaging of final product
  • Operates and maintains production equipment as it relates to manufacturing operations
  • Maintains records to comply with regulatory requirements. Documents all work on batch records according to Good Manufacturing practices. Performs batch record review as required by Production management
  • Completes ISO9001 QMS documentation, including Batch Records, Forms, Deviation reports, Failure Investigations and Change Controls
  • May be involved in identifying and documenting root causes to production issues
  • Able to work independently and be responsible for completion of any manufacturing tasks related to meeting production goals
  • May be asked to participate in other manufacturing operations, as required by management such as inventory control, packaging, and assisting in development activities

Education and/or Work Experience Requirements

  • Minimum of an A.S. in Technical discipline (e.g.EE Technology, Mechanical Technology, or Engineering, etc.) or 5-7 years of experience
  • Candidates with electro mechanical aptitude preferred
  • Ability to read, understand, and wire per electrical schematics
  • The ideal candidate would be conscientious and self-motivated with a proven track record as a quick learner
  • Excellent presentation, verbal and written communication skills
  • Self-starter with plenty of drive

Physical Requirements

  • Must be capable of lifting 50 pounds routinely

Apply

Essential Duties and Responsibilities:

  • Design and write complex technical and/or non-technical process/procedures, instructional, system operation and user documentation
  • Work with quality team to standardize FAT/SAT documents, manage changes history and maintain the document library
  • Work with customers to customize the documentation where necessary and assist in executing project documentation on time
  • Create Equipment Turnover Package, collaborate with quality for review and approval
  • Create document flow diagrams using Microsoft Visio
  • Revise or develop standardized formats and templates that meet documentation requirements and organizational needs
  • Ensuring compliance with regulatory requirements
  • Develop a standardized style user guide to be used by the customers
  • Assist in developing and then subsequently managing a robust document audit program
  • Review, revise, and ensure all operational documentation current and accurate
  • Suggest and implement improvements to the shared documentation repository
  • Analyze existing and potential content, focusing on reuse and single-sourcing opportunities
  • Where applicable, suggest process or technical solutions to institute greater single-source opportunities
  • Review or edit documentation created by other team members or business units

Education and/or Work Experience Requirements:

  • Bachelor’s degree in relevant technical field with 3-5 years’ industry experience as an effective technical writer
  • Strong ability to deliver high quality documentation paying attention to detail
  • Excellent ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures
  • Experience translating business specifications into user documentation
  • Excellent verbal and written communication skills with ability to research, interpret, analyze, and write by interpreting technical source information and determining appropriateness for inclusion into documentation
  • Proficient in the Microsoft Office suite (Excel/Word/PowerPoint/Visio) and Strong XML skills a must, including troubleshooting, with demonstrated experience in topic-based, structured writing
  • Expertise with Adobe FrameMaker
  • Experience interacting with all levels of the organization
  • Good at learning new software packages quickly
  • Proficient in managing multiple assignments simultaneously while working independently and with other teams
  • Capable of managing time and workload to meet project demands and deadlines, identify obstacles, assume responsibility for finding solutions, and timely communication of concerns and risks
  • Adept at adapting document style and readability for the intended target audience

Physical Requirements:

  • Must be capable of lifting 50 pounds routinely

Apply

Rancho Dominguez, CA

Expand All

We are seeking an experienced Product Manager to lead our lab and pilot scale TFF business. Our TFF Hollow Fiber Filters offer the industry’s leading membrane technology.  

The Product Manager will be responsible for driving the adoption of Hollow Fiber TFF by our customers and ensuring the long-term success of this business. This will be a “hands-on” operationally focused position managing the order lifecycle process from quoting to delivery. Working externally with the sales team, this position will be responsible for driving Hollow Fiber TFF adoption and driving the internal organization to improve lead time and expand the product range.

Responsibilities

  • Drive strategy and tactics, and manage the product life cycle to ensure business growth and strong customer satisfaction 
  • Support the global Sales organization, providing effective product positioning, sales tools, training, competitive analysis and in-field support as needed 
  • Analyze and respond to technical questions related to product use and performance, tangential flow filtration, product quality, and service features 
  • Derive forecast to ensure accurate demand planning, product build and revenue attainment 
  • Be responsible for assessing business performance through KPI tracking. 
  • Collaborate with sales and engineering to develop new or improve existing products based on VOC 
  • Work with Operations and Customer Service to ensure on time delivery of products and services  
  • Drive resolution of customer inquiries and complaints with required internal functions including Quality, Supply Chain, Manufacturing and R&D 
  • Liaise with Marketing to develop effective product collateral and campaigns  

Qualifications  

  • A BS degree or higher in an engineering or science discipline ; MBA is beneficial
  • A minimum of 15 years of experience in commercial product management, business management or sales and marketing 
  • Experience with filtration and hardware/equipment operations in bioprocessing is preferred 
  • Customer facing experience and the ability to build mutually beneficial, trusting relationships with internal and external stakeholders 
  • Strong attention to detail with excellent verbal and written communication skills 
  • Ability to take initiative, hold team members accountable for deliverables, and obtain support across departments 
  • Strategic, tactical and analytical thinking 
  • Ability to travel globally, up to 25% 
  • Proficient in MS Office Suite (Word, Excel, Powerpoint, Project and Visio)  

Apply

The Senior Production Planner performs all functions required to ensure maximum product availability while balancing the objectives of strategic inventory plans. This role aids in the development & implementation of planning strategies, policies, and procedures for successful minimization of inventory levels, improved cash flow & maximized efficiencies. Additionally, a Senior Production Planner aids in preparing data and analyzing inventory trends, internal key performance metrics, and the generation or management of key reports, metrics, and projects.

Responsibilities: 

  • Advanced knowledge of planning processes and forecast management 
  • Plans, schedules, coordinates and monitors products through the complete production cycle
  • Uses MRP, production BOMs and specifications to establish production schedules, labor loading and capacity requirements
  • Coordinates production plans to ensure material requirements will be met
  •  Provide support to higher levels of the supply chain organization
  •  Possesses a solid understanding of master data, supply chain, manufacturing operations and integration of these areas in the planning environment
  •  Maintain ERP master data to ensure data integrity
  •  Advanced knowledge of business concepts/principles (demand vs supply planning, finite scheduling, LIFR)
  •  Ability to generate consumption-based forecast & apply to MRP calculations
  •  Data analysis & decision making to support raw material supply and finished good demand
  •  Support new part release planning data
  •  Proficient MRP knowledge and ERP experience in a manufacturing environment
  •  Participate in planning performance metrics: Inventory Targets, LIFR, Available to Promise, Inventory Turns
  •  All other duties as required or assigned

Education and/or Work Experience Requirements:

  • Bachelors in Business or equivalent experience
  • 5- 7 year’s business experience
  • SAP is a +
  • Skilled in using ERP, Microsoft Excel, Word, Power Point, Outlook

Apply

Under general supervision. organizes and transports production and support material and equipment within the area of assignment .May use manual and powered material handling equipment and packaging equipment. The skills, efforts, responsibilities and working conditions are outlined below and made part of this description.

Job Functions (of this position): 

  • Locate, pick, move and store material and equipment according to established procedures, both written and verbal
  • Unloads and stores material in proper locations and perform receiving transactions.
  • Use material handling equipment such as hand and powered pallet movers, fork trucks and some powered packing equipment such as banders and shrink wrappers
  • Maintain proper documentation and records using various paper forms and computer systems
  • Follows and complies with all safety rules and regulations. Maintains individual work area/equipment in a neat, orderly manner. Detects and reports improper operations, faulty equipment/ tooling, defective materials and unusual conditions to supervisor. Count items and audit for package/ shipping damage.
  • Maintain necessary records as required. Moves material as necessary in performance of duties. Cycle count as scheduled
  • Obtain and maintain proper training for powered industrial trucks. Maintain daily logs
  • Perform other duties as directed.
  • Experience using a scanning gun
  • Experience and understanding of BIN or Material transfers
  • Inventory Control experience / Bin Checking and Daily Counting
  • Good Problem Solving Skills
  • Ability to learn quickly and thrive in a fast paced environment

Considerable physical demand consisting of frequent lifting or moving average weight material or occasionally lifting or moving heavy weight material in difficult positions.

Requirements:

  • High School diploma with 1-2 years experience:
  • Warehouse: 1 year (Required)
  • Material Handler: 1 year (Required)
  • Forklift: 1 year (Required)
  • SAP: 1 year (Required)

APPLY

Schedules and coordinates flow of work within or between departments of manufacturing plant to expedite production by performing the following duties.

Essential Duties and Responsibilities:

  • Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
  • Works with Scheduler to ensure available capacity is correct.
  • Tracks and communicates capacity availability, how much of a machine, bench, and/or resource time is available.
  • Uses defined manufacturing area capacities and historical timings to set work center throughput and completion timing expectations.
  • Works with Production Leads and Manufacturing Manager on setting work center capacity based upon staffing, number of production days per week and shifts of production per day per production line based upon capacity constraints and work order demand.
  • Understands, identifies, and manages manufacturing constraints and rate limiting steps.
  • Identifies training gaps and oversees training matrix completion.
  • Accountable for work order movement, manufacturing capacity, and material availability.
  • Works with Leads to ensure shop floor scheduling metrics are filled in, reported, and up to date.
  • Leads daily production scheduling meeting that includes manufacturing leads.
  • Attends scheduling meetings.
  • Works with OpEx and Manufacturing Science teams on capacity performance and improvement projects.
  • Is the primary contact for work order movement through clean room manufacturing flow.
  • Maintains daily manufacturing metrics including but not limited to schedule adherence, schedule attainment, rework, scrap, and overtime.
  • Maintains daily manufacturing metrics including but not limited to schedule adherence, schedule attainment, rework, scrap, and overtime.
  • Tracks and analyzes process data in control chart form.
  • Perform other duties as assigned by Supervisor.

Education/Experience:

  • Associate degree or Bachelor’s degree will be an advantage.
  • 2 years of related experience and proven effectiveness in a leadership role.
  • Extensive hands-on experience with a computerized production planning system such as MRP II.
  • Advanced Excel experience preferred.
  • Ability to analyze situations and react in a timely manner necessary.
  • Lean-Sigma Yellow or Green Belt trained v Understanding of manufacturing systems, their strengths and limitations
  • Previous experience with high mix, batch manufacturing environments
  • Previous experience in leading process improvement projects a plus

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear.
  • frequently required to sit; reach with hands and arms and stoop, kneel, crouch, or crawl.
  • must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Specific vision abilities required by this job include peripheral vision and depth perception.

APPLY

The Associate Director, Procurement performs and leads all functions needed to ensure the lowest total cost of purchased materials and services for a site. The purpose is to balance the objectives of maximum product availability with strategic inventory plans. Some products may be purchased from key suppliers and replenished to the Distribution Centers. The Associate Director of Procurement Leads in high level global critical negotiations to implement proactive procurement philosophies, strategies, policies, and procedures for successful integration into multiple business plans across various corporate departments. Additionally, is responsible for preparing data and analyzing inventory trends, external and internal key performance metrics, and proposing process improvement and the generation or management of key reports, metrics, and projects. This is a service position and is responsive to the needs of internal and external (suppliers) customers. Manage and mentor junior employees as required.

Essential Functions:

  • Ownership of procurement processes and strategic supplier management on a global basis
  • Management of the daily Procurement team activities; ensure MRP order queue is appropriately balanced across the buyers; oversee the output quality of Procurement team including adherence to our global PO Policy
  • Lead and execute procurement strategies that align with business stakeholders
  • Manage request for proposal (RFP) process for assigned categories
  • Provide wide scope of guidance on the implementation of procurement process supporting an SAP implementation
  • Strong experience in upwards communication and senior stakeholder management skills supported by good interpersonal competencies (communication, presentation)
  • Manage and maintain relationships with key business leaders to understand and support their supplier needs
  • Summarize and report on accomplishments and performance against KPIs, tracking progress via reports for senior leadership, developing metrics and KPIs to measure team or project success
  • Seasoned project management and team leadership skills
  • Skill with influencing internal and external stakeholders, including executive management, to achieve the initiative objectives
  • Act as a change management leader / influencer to mature process and ensure new processes and procedures are appropriately understood and adopted within the organization
  • Experience in negotiating pricing, contract terms and conditions including statements of work (SOW)
  • Moderate to complex level of financial analysis knowledge including business modeling and problem-solving skills
  • Demonstrated record of successful cost reduction and operational efficiency
  • Proven record of integration activities, driving change and partnering with stake holders   

Nature and Scope:  

Interacts with all levels of manufacturing employees. Works with the Finance Department on budget issues and problem reason codes on IT Transactions. Interfaces with Production Managers to establish and maintain effective interdepartmental processes. Interacts with Production Planners and Buyers on inventory and scheduling issues affecting material handling. Coordinates material transfer, inventory control, and shipping activities with subcontractors. Participates in or leads process improvement projects.   

Complexity/Decision Making: 

Exercises judgment within broadly defined practices and policies. Selects methods and techniques of obtaining solutions to problems of relatively routine to diverse scope and moderate to highly complexity, requiring analysis of identifiable factors. 

Leadership/Teamwork/Contacts: 

Has contact with all levels of company employees as well as frequent interaction with suppliers. 

Supervision: 

  • Has contact with all levels of company employees as well as frequent interaction with vendors. 
  • Education & Experience
  • Minimum of 8-10 years of related procurement and supply chain experience in a management position
  • Bachelor’s degree or equivalent work experience
  • Comprehensive, hands on knowledge of procurement processes, controls and best practices
  • Proficient using Microsoft Office Applications (Excel, PowerPoint, Visio, Word & Outlook)
  • MAPICS and/or SAP is a + 

OTHER DUTIES:

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Apply

Responsibilities: 

  • Use investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes
  • Perform FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability concerns
  • Monitor the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place
  • Prepares quality/inspection plans, procedures and instructions, and product / raw materials specifications
  • Performs testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, or test methods
  • Reviews manufacturing planning for appropriate quality requirements
  • Prepares appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures documentation contains the necessary criteria and provisions for effective inspection and testing
  • Compile and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the completion and effectiveness of corrective actions
  • Perform investigations and prepare reports for customer complaints
  • Conducts or participates in ISO audits, internal audits, and Customer audits
  • Prepare and review Quality Technical Agreements and supplier evaluation surveys
  • Support process/product improvement projects, product design reviews, products and raw materials non-conformance investigations, review and disposition
  • Perform ISO, GDP, and technical training
  • Interface at all organizational levels within the company, customers, and suppliers
  • Act as direct quality liaison with Engineering, Manufacturing, Marketing and customers
  • May serve as Lab Safety Coordinator in conjunction with the company’s Hazard Communication Program

Qualifications:

  • Bachelor’s degree in Engineering or Life Science
  • 5 yrs Quality Engineering and/or Manufacturing Engineering experience
  • Demonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations
  • Knowledge of Investigative / problem solving tools and scientific/technical investigations
  • Experience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data analysis
  • Good interpersonal, verbal communication and writing skills. Able to express thoughts and concepts at both technical and administrative level
  • Demonstrated ability to proficiently review technical and quality requirements, deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.)
  • Good knowledge and skills in the use of advanced computer programs for word processing, spreadsheets, database and flow charts 

Experience:

  • Quality Engineer II 5 to 7 years as QE or Manufacturing Engineer

Apply

This role reports directly to the Accounting Manager and will be a key member of the Company’s Rancho Dominguez accounting team. The Senior Accountant will be primarily responsible for assisting with the financial close, financial reporting and revenue recognition, in addition to providing key financial analysis and aiding the Senior Cost Accountant, where required. The individual in this position must have a hands-on knowledge of ERP systems, strong understanding of Sarbanes Oxley and controls improvement, and the ability to work effectively in a fast moving, cross-functional, environment. 

Responsibilities:   

  • Assist with and complete monthly, quarterly and annual close processes, including any required analysis, the preparation of account reconciliations and posting of journal entries 
  • Review revenue transactions and ensure compliance with the new revenue recognition standard and adequate cut off
  • Assist the Accounting Manager in preparation of support for the parent Company’s SEC filings 
  • Drive compliance of SOX controls and support the implementation of new processes to enhance the Company’s control environment 
  • Partner with cross-departmental groups to ensure SOX controls are operating effectively  
  • Prepare audit schedules in conjunction with financial and SOX audits 
  • Assist with the roll out of a new ERP system 
  • Partner with financial planning and analysis and operations teams to coordinate budgeting and forecasting 
  • Assist the Senior Cost Accountant with monthly inventory accounting and analysis 
  • Perform special financial and accounting analysis projects, as requested   

Qualifications:   

  • Bachelor's degree in Accounting, with MBA and/or CPA preferred 
  • Public accounting experience preferred (Big 4/National CPA firm) 
  • At least 3 years of accounting experience required 
  • Manufacturing experience preferred  
  • Very strong attention to detail and professional curiosity 
  • Strong Excel skills (comfortable with pivot tables/ large data manipulation) 
  • Strong understanding of US GAAP and SOX internal controls  
  • Excellent analytical and technical accounting skills 
  • Ability to organize and manage multiple priorities; deadline oriented 
  • Excellent communication and inter-personal skills, both written and verbal

Apply

Essential Duties and Responsibilities: 

This assembly position performs a wide variety of fiber assembly, filtration product assembly or sub-assemblies. Determines and/or follows methods and sequence of operations in performing fiber bundling, filter potting, filter welding, fitting on assembly units and packaging. The employee also works as a team member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion.

  • Perform manual assembly of complex fiber, membrane, and polycarbonate components.
  • Follow detailed manufacturing and assembly procedures.
  • Perform routine device testing. 
  • Follow good manufacturing practices per company operating procedures.
  • Clean, maintain, and operate automated production equipment per SOP's.
  • Clean and organize workbenches before and after shift.
  • Perform other duties as assigned by Management.
  • Other duties may be assigned.  

Education and/or Work Experience Requirements: 

  • High School Diploma, GED, or equivalent required.
  • 0 – 1 years of production/manufacturing with medical device assembly experience preferred

Physical Requirements: 

  • Regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear.
  • Frequently required to sit; reach with hands and arms and stoop, kneel, crouch, or crawl.
  • Must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. 
  • Specific vision abilities required by this job include Peripheral vision and Depth perception.

APPLY

Essential Duties and Responsibilities:

  • Prepare samples as required per applicable instructions
  • Performs samples for testing fiber qualification
  • Performs visual inspection and dimensional analysis using vision system
  • Sample testing for fiber characteristics such as performance using various testing equipment (Measurement equipment, refractometer, spectrophotometer)
  • Preparation of chemical solutions for testing
  • Routine calibration on some equipment as needed
  • Follow GDP and applicable Repligen quality requirements
  • Records test data in excel spreadsheet and analyze against specifications
  • Reports nonconforming results to supervisor in timely manner
  • Maintenance of laboratory equipment, instruments, and inventory
  • Perform integrity testing of assembled modules
  • Perform Environmental monitoring of clean room particle count and water testing
  • Perform Endotoxin testing of water and modules as required per specifications
  • Adherence to all company Quality policies and procedures
  • Contributes to team effort as needed

Education and/or Work Experience Requirements:

  • Laboratory or manufacturing setting work experience preferred, within a controlled Quality environment
  • Capable of prioritizing tasks and time management
  • Ability to communicate effectively, especially within a team environment
  • Minimum of High School diploma required; advanced education preferred
  • Microsoft software skills required
  • Experience in pharmaceuticals or medical devices

Physical Requirements:

  • Ability to work in a laboratory environment and exposure to hazardous materials
  • Regularly required to stand, sit, walk, use hands and arms
  • Lift/ or move up to 25 pounds

Apply

Irving, TX

No current openings

Lund, Sweden

Expand All

Har du intresse för kemi och erfarenhet av processarbete inom industrin? Vill du vara med och tillverka produkter som bidrar till att bota cancer och reumatiska sjukdomar? Då kan du vara den vi söker! Hos oss blir du del av en dynamisk verksamhet med storskalig tillverkning av affinitetsligander och tillväxtfaktorer. Vår verksamhet utmärks av ständig utveckling inom produkter, processer och analysmetoder. 

Position: Processoperatör
Plats: Lund
Vikariat på ca 1 år
Tillträde: 
omgående

Om tjänsten
Vi söker dig som vill jobba som processoperatör på vår produktionsanläggning på S:t Lars i Lund. I rollen ingår du i en avdelning om 30 personer som ansvarar för fermentering, upparbetning, rening och fyllning/frystorkning av företagets produkter. Arbetsuppgifterna som processoperatör innefattar att utföra arbete efter standardiserade dokument, kalibrerings-och valideringsarbete och att styra processer efter givna metoder. Tjänsten innebär skiftarbete dag, kväll och natt.

Andra förekommande arbetsuppgifter:

  • Uppdatera SOPar och BP
  • Follow up/CAPA
  • Delta i förbättringsarbete

Vi söker dig med följande kvalifikationer:
Då rollen är ett vikariat tror att denna rollen passar dig som precis är klar med din utbildning inom kemi/naturvetenskap alternativt är i början av din karriär. Skulle du ha någon erfarenhet av kalibrering, renrumsarbete, arbete enligt GMP/ISO 9001 ser vi det som meriterande. Du har obehindrade kunskaper i svenska språket samt engelska i tal och skrift.

Som person är du kommunikativ och ärlig. Vi jobbar med ständiga förbättringar och lean-arbete är en stor del av vår vardag. Du är samarbetsinriktad och engagerad och du trivs i en flexibel vardag. Då noggrannhet är av största vikt i vår verksamhet, ser vi även att du arbetar med god struktur och precision.

Vi erbjuder
På Repligen tror vi att din egen personliga utveckling är nyckeln till framgång. Hos oss får du växa och utvecklas då vi ger dig möjlighet att ta ansvar i projekt som inte nödvändigtvis är kopplat till ditt direkta ansvarsområde. Vi har högt i tak och en god teamkänsla - tillsammans med vårt positiva och trygga team av kollegor är vi övertygade om att vi kan erbjuda dig en stimulerande och spännande miljö som hjälper dig att ta nästa steg i din karriär.

Ansökan
Du ansöker genom att fylla i ansökningsformuläret uppe till höger. Sista ansökningsdag är 2019-09-30. Observera att vi inte tar emot ansökningar via e-post.

Har du frågor relaterat till rekryteringsprocessen är du välkommen att kontakta Christoffer Hällefors på epost christoffer.hallefors@roirekrytering.se.

Välkommen in med din ansökan!

Apply

Har du intresse för kemi och erfarenhet av processarbete inom industrin? Vill du vara med och tillverka produkter som bidrar till att bota cancer och reumatiska sjukdomar? Då kan du vara den vi söker! Hos oss blir du del av en dynamisk verksamhet med storskalig tillverkning av affinitetsligander och tillväxtfaktorer. Vår verksamhet utmärks av ständig utveckling inom produkter, processer och analysmetoder. 

Position: Processoperatör
Plats: Lund 
Tillsvidareanställning

Tillträde: omgående

Om tjänsten
Vi söker dig som vill jobba som processoperatör på vår produktionsanläggning på S:t Lars i Lund. I rollen ingår du i en avdelning om 30 personer som ansvarar för fermentering, upparbetning, rening och fyllning/frystorkning av företagets produkter. Arbetsuppgifterna som processoperatör innefattar att utföra arbete efter standardiserade dokument, kalibrerings-och valideringsarbete och att styra processer efter givna metoder. Tjänsten innebär skiftarbete dag, kväll och natt.

Andra förekommande arbetsuppgifter:

  • Uppdatera SOPar och BP
  • Follow up/CAPA
  • Driva och delta förbättringsarbete
  • På sikt ev. handleda upplärning

Vi söker dig med följande kvalifikationer:
Vi ser gärna att du har erfarenhet av processarbete inom industrin och en kemibakgrund från utbildning och/eller arbete. Du har arbetat i labb-miljö, har kalibreringsvana och erfarenhet från renrumsarbete. Det är en merit om du har arbetslivserfarenhet av GMP/ISO 9001. Du har obehindrade kunskaper i svenska språket samt engelska i tal och skrift.

Som person är du kommunikativ och ärlig. Vi jobbar med ständiga förbättringar och lean-arbete är en stor del av vår vardag. Du är samarbetsinriktad och engagerad och du trivs i en flexibel vardag. Då noggrannhet är av största vikt i vår verksamhet, ser vi även att du arbetar med god struktur och precision.

Vi erbjuder
På Repligen tror vi att din egen personliga utveckling är nyckeln till framgång. Hos oss får du växa och utvecklas då vi ger dig möjlighet att ta ansvar i projekt som inte nödvändigtvis är kopplat till ditt direkta ansvarsområde. Vi har högt i tak och en god teamkänsla - tillsammans med vårt positiva och trygga team av kollegor är vi övertygade om att vi kan erbjuda dig en stimulerande och spännande miljö som gör att du vill bli en del av vår fortsatta framgång.

Ansökan
Du ansöker genom att fylla i ansökningsformuläret uppe till höger. Sista ansökningsdag är 2019-09-30. Observera att vi inte tar emot ansökningar via e-post.

Har du frågor till relaterat rekryteringsprocessen är du välkommen att kontakta Christoffer Hällefors på epost: christoffer.hallefors@roirekrytering.se.

Välkommen in med din ansökan!

Apply

Ravensburg, Germany

No current openings

Field

Expand All

Repligen is a bioprocessing-focused life sciences company bringing over 30 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs.

We are seeking a US- based Field Application Scientist to technically support the upstream product lines in the bioprocess industry. This individual will use their knowledge of cell culture process development, filtration and manufacturing to support customers and our sales team in pre- and post- sales opportunities.

The successful candidate will also work closely with Repligen colleagues including sales account managers, product management, quality assurance, and R&D scientists/engineers to ensure our products continue to serve the evolving needs of our customers in the bioprocessing industry.

This is a field-based position requiring domestic and some international travel. The position will be preferably based in NY, NJ, PA, MD or NC. 

Responsibilities

  • Work in coordination with the Repligen sales team and product management to provide pre- and post-sales support to customers for the XCell™ ATF systems, Spectrum® Hollow Fiber and KrosFlo® TFF System product lines. This will include responding to customer requests for technical support, giving technical seminars, performing product demonstrations, providing on-site/in-lab support, troubleshooting and assisting with the execution of voice of customer surveys
  • Develop and execute project plans to meet customer needs using Repligen technologies
  • Draft detailed technical protocols/reports from customer interactions
  • Provide knowledge and customer feedback to product management and R&D for the continuous improvement of products
  • Contribute to applications data and collateral generation by liaising with R&D and marketing  

Minimum Qualifications

  • A Bachelor’s degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field
  • 6+ years’ experience working in a cell culture discipline in a development or manufacturing technical support setting in the bioprocessing industry. Working knowledge of perfusion, TFF, scale-up/scale-down, tech transfer and cGMP requirements
  • Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required
  • Strong problem solving and analytical skills
  • Ability to prioritize and work independently to achieve defined goals
  • Ability to work well within a global, cross functional team
  • Must be willing and able to work flexible hours to accommodate client schedules
  • Up to 50% domestic travel and occasionally internationally
  • Must be proficient in English, writing and speaking

Apply

Repligen is a bioprocessing-focused life sciences company bringing over 30 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs.

We are seeking a US- based Field Application Scientist to technically support the upstream product lines in the bioprocess industry.  This individual will use their knowledge of cell culture process development, filtration and manufacturing to support customers and our sales team in pre- and post- sales opportunities.

The successful candidate will also work closely with Repligen colleagues including sales account managers, product management, quality assurance, and R&D scientists/engineers to ensure our products continue to serve the evolving needs of our customers in the bioprocessing industry.

This is a US west coast field-based position requiring domestic and some international travel.  The position will be preferably based in CA.

Responsibilities: 

  • Work in coordination with the Repligen sales team and product management to provide pre- and post-sales support to customers for the XCell™ ATF systems, Spectrum® Hollow Fiber, TFDF™ Technology and KrosFlo® TFF System product lines.   This will include responding to customer requests for technical support, giving technical seminars, performing product demonstrations, providing on-site/in-lab support, troubleshooting and assisting with the execution of voice of customer surveys
  • Develop and execute project plans to meet customer needs using Repligen technologies
  • Draft detailed technical protocols/reports from customer interactions
  • Provide knowledge and customer feedback to product management and R&D for the continuous improvement of products
  • Contribute to applications data and collateral generation by liaising with R&D and marketing

Minimum Qualifications:

  • A Bachelor’s degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field
  • 5+ years’ experience working in a cell culture discipline in a development or manufacturing technical support setting in the bioprocessing industry.  Working knowledge of perfusion, TFF, scale-up/scale-down, tech transfer and cGMP requirements.
  • Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required
  • Strong problem solving and analytical skills
  • Ability to prioritize and work independently to achieve defined goals
  • Ability to work well within a global, cross functional team
  • Must be willing and able to work flexible hours to accommodate client schedules
  • Up to 50% domestic travel and occasionally internationally
  • Must be proficient in English, writing and speaking

Apply

Repligen is seeking a highly motivated and experienced Bioprocessing Account Manager (BAM) whose primary role will be to sell an expanding portfolio of highly differentiable, high-value products and flexible solutions that address critical steps in the production of biologic drugs, gene therapy and cell therapy - to new and existing Biopharmaceutical customers across a territory spanning Southern Germany and Austria. 

The ideal candidate will demonstrate a high level of motivation to succeed, highly developed sales and territory management skill sets in the Life Sciences sector, and is now looking for the next challenge at a rapidly evolving and innovative bioprocessing-focused life sciences company.

Reporting directly to the Director of Sales, Europe, this is a home office-based role, within the territory.  Depending on location, 50% travel will be necessary. 

Responsibilities: 

  • Drive sales process to meet or exceed sales and profitability targets 
  • Promote and sell a portfolio of upstream, downstream and single use products; be able to articulate key differentiators and value proposition of company products 
  • Develop and execute a territory management plan • Conduct sales negotiations with technical and planning departments 
  • Establish and maintain Strategic Key Account relationships
  • Develop new target accounts across the territory
  • Provide accurate and timely sales reporting and forecasting with a market leading CRM tool 
  • Maintain contact with key market infrastructure partners and identify new sales and business opportunities
  • Be the customer and market advocate to the internal organization
  • Interface with Business and Market Development to ensure that appropriate product, market and competitive information is shared in an accurate and timely manner 
  • Support the development of sales collateral 
  • Provide Manufacturing and QA/QC operations with timely information to support forecasting, customer complaint handling and facility audits 
  • Execute all aspects of field sales activity to include customer visits, technical presentations and laboratory demonstrations 
  • Attend, manage and follow up on trade show activities 

Qualifications:

  • A minimum of a BSc degree + in a scientific discipline or equivalent 
  • A minimum of 5+ years of experience in the biopharmaceutical or life science industries. 
  • A strong understanding of Cell Culture, Chromatography and Filtration is a priority. However, additional skills and understanding and Upstream and Downstream processing would also be beneficial.
  • Proven successful sales track record and key account management experience
  • Proven ability to build mutually beneficial, personable, trusting relationships with customers, suppliers and partners 
  • Strong analytical and forecasting skills 
  • Willing to travel extensively throughout the territory
  • Attention to detail, excellent verbal and written communication skills, good analytical and problem solving skills, Multi-tasking skills, and strong organizational skills

APPLY

The Field Service Engineer (FSE) is responsible for installing, maintaining and servicing Repligen products; XCell ™ ATF and Spectrum TFF filtration.   The FSE will provide remote and onsite support and work closely with the sales and product managers in troubleshooting customer needs. The FSE shall maintain accurate documentation of all service activities and escalating issues as needed.

Responsibilities:

  • Provide service support, including repair and preventive maintenance, for equipment and document all service activities. Service will be executed at customer sites and at a Repligen location in APAC
  • Perform installation and training on equipment, software, and other accessories; report back on issues, orders and parts needed
  • Perform Site Acceptance Testing (SAT) on Repligen products at customer sites globally
  • Schedule and perform preventative maintenance on equipment as required
  • Problem-solving tasks may include resolving mechanical/software issues; resolving operating system bugs; and reinstalling software or hardware
  • Enhance the customer’s positive experience by recognizing their needs and providing solutions that meet and often surpass those needs
  • Communicate effectively both internally and externally, to document actions and item performed, schedule future preventive maintenance needs, and other engineering functions. Communicate routinely with Field Service Manager based in the US and other FSEs globally
  • Provide phone support to customers and service group personnel related to equipment hardware and software performance and service part ordering\
  • Document and distribute technical information regarding resolutions to field problems, hardware and software changes, and product quality improvements
  • Review service manual documentation to ensure accuracy and current revision levels
  • Determine appropriate preventive maintenance procedures, service parts kits, and schedules to ensure effective on-going equipment maintenance

Qualifications:

  • Bachelor's Degree or Technical School (Electronics)
  • At least 5 years of experience in the repair, maintenance, and installation of equipment used in a scientific instrument, laboratory or bioprocess settings
  • Electronic and mechanical aptitude required
  • Maintains professional and technical knowledge
  • Strong written and verbal communication skills in English required
  • Ability to draft and execute SOPs and work instructions
  • The position requires up to 50% travel in APAC and occasional global travel

Apply

Repligen is the only company experienced in both flat-sheet cassettes and hollow fiber tangential flow filtration and dedicated to making it easier, faster and less expensive for customers to scale into production. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs.

We are seeking a European based Field Application Scientist to technically support the tangential flow filtration (TFF) product lines in the bioprocess industry.  This individual will use their knowledge of process development, filtration and manufacturing to support customers and our sales team in pre- and post-sales opportunities.

The successful candidate will work closely with Repligen colleagues including sales account managers, product management, quality assurance, and R&D scientists/engineers to ensure our products continue to serve the evolving needs of our customers in the bioprocessing industry.

This is a field-based position requiring European and some international travel.  The preferred position will be based in Germany, Austria or Switzerland supporting central Europe.

Responsibilities: 

  • Work in coordination with the Repligen sales team and product management to provide pre- and post-sales support to customers for the TangenX flat sheet, Spectrum® hollow fiber, and KrosFlo® TFF System product lines. This will include responding to customer requests for technical support, giving technical seminars, performing product demonstrations, providing on-site/in-lab support, troubleshooting and assisting with the execution of voice of customer surveys
  • Develop and execute project plans to meet customer needs using Repligen technologies
  • Draft detailed technical reports from customer interaction
  • Provide knowledge and customer feedback to product management and R&D for the continuous improvement of products
  • Contribute to applications data and collateral generation

Qualifications: 

  • A Bachelor’s degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field
  • 6+ years’ experience working in a downstream purification discipline in a development or manufacturing setting in the bioprocessing industry.  Relevant experience in the development of concentration and UF/DF unit operations.  Working knowledge of scale-up/scale-down, tech transfer and cGMP requirements.
  • Upstream cell culture experience is a plus
  • Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required
  • Strong problem solving and analytical skills
  • Ability to prioritize and work independently to achieve defined goals
  • Ability to work well within a global, cross functional team
  • Must be willing and able to work flexible hours to accommodate client schedules
  • Must be proficient in English, writing and speaking.
  • Up to 50% domestic travel and occasionally internationally

Apply

If you are interested in working for Repligen, but do not see a current opening that matches your skillset, you may submit a resume for general consideration.

Submit your Resume