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WALTHAM, MASSACHUSETTS, USA - HEADQUARTERS

The ELISA Manufacturing Associate will assist in the ELISA Lab Manufacturing group by building the Kit reagents for ELISA Kit inventory.  This person will focus on training and working with the Manufacturing Associate II an the ELISA Manager.

Responsibilities:

  • Train in all aspects of Repligen ELISA Kit Manufacturing
  • Able to use Pipettes and have ELISA testing experience
  • Responsible for ensuring all ELISA Manufacturing operations are carried out in accordance with the Repligen ISO 9001 Quality Management system
  • Manufacture all ELISA Reagents : perform dispensing, capping and labeling operations per approved Batch records
  • Manufacture ELISA Plates: perform  coating, blocking ,washing and packaging of plates per approved Batch records
  • Package Kits for Inventory
  • Interact with Materials Management to purchase of Raw Materials required.
  • Ensure the timely completion of all Paperwork and work sheets, using ERP and EDMS
  • Maintain an appropriate level of housekeeping and safety within the ELISA Lab

Qualifications:   

  • Requires an AS/BS or equivalent with 2 + years of relevant experience in document controlled manufacturing.
  • Skilled in the manufacture and testing of ELISA products is preferred.
  • Previous experience in QC or Analytical Development  is desirable
  • Experience in GMP or ISO9001 manufacturing environment is preferred

APPLY

The QC Analyst will report directly to the QC Manager and will be primarily responsible for performing in-process testing of Repligen Bioprocessing ligands, and release of OPUS pre-packed chromatography columns.   The analytical activities supporting this position include HPLC, SDS-Page, FTIR analysis and microbial testing (bioburden & endotoxin). The successful candidate will support activities for facilities including collection of Environmental Monitoring data in the ISO clean rooms as well as RODI collection and analysis.  The candidate will actively follow Repligen ISO 9001 Quality Management System in support of the Bioprocessing manufacturing processes and final product testing, including additional laboratory compliance as assigned by the QC Manager.

Responsibilities:

  • Performs final testing of finished OPUS® pre-packed chromatography columns and documents results for product release (bioburden and endotoxin)
  • Performs in-process concentration analysis by UV and HPLC
  • Performs sample preparation for FTIR analysis 
  • Perform RODI water testing
  • Carries out monitoring of ISO controlled environments and records data for trend analysis
  • Writing and reviewing SOPs, writing deviations, reviewing data of peer reviews
  • Assists with OOS investigations and change controls associated with QC testing

Qualifications:  

  • 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 
  • Strong HPLC experience and a good understanding of the fundamentals of column chromatography
  • Experience with microbiological assays (Environmental monitoring, water testing) 
  • Experience with ELISA is a plus
  • Gel electrophoresis
  • FTIR (Fourier Transform Infrared Spectroscopy) experience is a plus 

APPLY

This position will function in Repligen's OPUS product group. The successful candidate will play a key role in growing the OPUS business by ensuring that the department's production and quality goals are met in a timely and cost effective manner. Applicants must have strong technical knowledge in packing of a wide variety of chromatography media and buffers.

The position will require you to investigate what packing methods have been successful internally as well as in the literature to enable a growing group to become more successful in column packing and measured through 1st time yield improvements. You will work with our customer requirements, work orders, to better integrate them into the Repligen manufacturing process, with the ultimate goal of packing all columns per a set of standard Repligen processes.  You will work with product development to keep documentation up to date as new products are developed and product revisions are released.  You would be involved with tech transfers between product development and manufacturing, as well as tech transfers between manufacturing plants.  Your skills would be required for any quality related issues regarding in suite problems, returns, and/or problem column packs.

Technical expertise in the area of the OPUS manufacturing process is important.  

Experience working in a classified cleanroom, and knowledge of ISO/GMP/document controlled processes would be beneficial. Attention to detail, and the ability to work in a team environment are essential. 

Responsibilities

  • Take lead role to integrate customer requirements into our manufacturing process.  This will include capturing all pertinent details in the work order, and variations in the batch records, and communication of key components to materials planning personnel and/or anybody in the manufacturing process.
  • Strive to make continuous improvements to our manufacturing process through revisions to batch records, process flow/requests between internal groups/departments, LEAN and 5S principles, and overall operator training.
  • Work to implement planned, unplanned deviations, and CAPA’s and close in a timely manner
  • Train the team in product costing within the ERP system.
  • Work with materials production planning to gain a better understanding of the ERP system and how to make better use of it for production.
  • Work with materials planning on implementing a KanBan type process for in suite OPUS materials.
  • Capable and available of column packing when needed.
  • Would be involved in New Product Introductions and process transfers between Product Development and Manufacturing departments.
  • Analyze and report on column packing data to better enable process improvements.
  • Provide clear and detailed documentation of work through maintenance of an electronic based scientific notebook, technical reports and oral presentations 
  • Work on joint technology projects with the R&D groups of partner companies and customers
  • Compliance with all aspects of Repligen's IS09001 Quality Management System

Qualifications

  • A minimum of a BS degree in Chemical Engineering, Chemistry, or Biochemistry would have the requisite theoretical background
  • A minimum of 5-10 years’ experience in the biotechnology manufacturing and/or process development with focus in chromatography technologies
  • Experience with the OPUS manufacturing processes and column packing processes
  • Working knowledge of Great Plains ERP system
  • Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment.
  • Very good communication skills, both written and verbal.

APPLY

The Senior Production Scheduler position is responsible for developing production/supply plans which take into account forecasts, availability of material and manufacturing capacity. The incumbent is responsible for identifying and maintaining the appropriate planning parameters in MRP system to optimize subassembly production and raw material supply plans. This individual will be the point of contact for supply escalations from Customer Service, Sales and Product Management. This individual may also be responsible for providing materials to manufacturing areas based on planned production schedules and for the appropriate shipping of finished goods to various distribution centers in support of management policies for customer delivery and inventory levels. 

Additionally, the Senior Production Scheduler will work closely with Manufacturing, Manufacturing Engineering, Development and Quality to ensure an efficient and effective supply of components and sub-assemblies to support manufacturing.  As well as support and contribute to any continuous improvement activities for service level improvement and process efficiencies.

Responsibilities

  • Plan production requirements based on forecast from global operations leader and product management
  • Evaluate and execute all MRP plans to meet corporate initiatives
  • Liaison between business leaders and manufacturing
  • Support ERP/MRP implementation
  • Support product management with new product launches, product improvements and changes, and product rationalization 
  • Lead potentially high visibility teams requiring accurate and timely data analysis and the ability to meet project deadlines
  • Develop, implement and manage metrics to track overall success and effectiveness.  Including but not limited to: On time delivery, line item fill rate, inventory reporting, and capacity reporting
  • Data analysis and decision making to support raw material supply and finish goods demand
  • Implements short and long range inventory strategies
  • Recommends solutions to complex inventory issues
  • Negotiates issues related to planning and logistics
  • May be required to support procurement activities

Qualifications

  • Bachelor’s Degree in manufacturing operations, business administration, operations management, or purchasing
  • 5-8 years’ planning or procurement experience, preferably in a high paced working environment
  • APICS or ISM certification is strongly desired.  Some experience in a scientific environment. Knowledge of chemistry or biology a plus.
  • Strong project management and team leadership skills with the ability to develop strong support for change with all levels of internal and external organizations
  • Strong organization skills with the ability to manage and prioritize multiple tasks
  • Effective interpersonal and negotiation skills
  • Ability to make decisions and solve practical problems with a variety of variables in situations where standardization may be limited
  • Self-driven, results oriented, and motivated to work effectively with minimal direct supervision
  • Previous ERP experience a must
  • Proficiency with off-the-shelf database applications

APPLY

 

The Incoming Quality Manager is recognized as an expert internally in the principles and application of quality assurance and compliance for raw materials. The Manager will coordinate the team responsible for incoming raw materials inspection activities to determine product acceptance while assuring procedures are compliant and proper records are maintained. 

As part of the Quality group, the Incoming Inspection Manager is responsible to provide quality oversight and support to operations at the facility for the following key areas - support of manufacturing operations across all phases of development and commercial, support and materials management and effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

Responsibilities:  

  • Perform accurate physical and visual inspection of all incoming raw materials and components as per Inspection Plans and Specification Requirements.
  • Approve incoming inspection reports.
  • Work with Manufacturing and Materials Management in addressing nonconforming materials in MRB. 
  • Support general supplier quality initiatives
  • Assist in customer complaint investigations
  • Responsible for commercial disposition.
  • Act as key compliance liaison with different functional departments.
  • Assists in development of inspection and ISO documentation as required.
  • Support of ISO investigations and associated CAPAs.
  • Responsible for conducting / leading compliance walk-throughs of the manufacturing site
  • Ensure calibration and maintenance is performed on inspection equipment.
  • Train contract / temporary and new hire employees in the Incoming inspection procedures.
  • Quality document updates including inspection plans, procedure changes, MRB reports, etc. 

Qualifications:

  • Requires a Bachelor’s degree with a minimum of 4 years’ experience in a related industry or equivalent experience, including 2- 4 years' supervisory experience.
  • Requires working knowledge of physical inspection techniques and equipment.
  • Requires knowledge of inspection/sampling techniques and familiarity with ANSI/ASQZ1.4
  • Knowledge of ISO 9001 Quality System Regulations.
  • Excellent verbal and written communication.
  • Computer literacy using Microsoft programs.
  • Quality Inspector Certification a plus.

APPLY

SHREWSBURY, MASSACHUSETTS, USA

     No current openings.

WORCESTER, MASSACHUSETTS, USA

     No current openings.

RANCHO DOMINGUEZ, CALIFORNIA, USA

Responsibilities:

  • Tests and inspects products at various stages of production process.  Compiles and evaluates statistical data to determine and maintain quality and reliability of products.
  • Selects products for tests at specified stages in production process and tests products for variety of qualities such as dimensions, performance and mechanical, electrical or chemical characteristics.
  • Records test data, applying statistical quality control procedures.
  • Prepares graphs or charts of data or enters data into computer for analysis.
  • Receiving, inspecting and confirming complaints of Spectrum line products.
  • Preparation of chemical solutions used in the lab.
  • Maintenance of laboratory glassware and inventory.
  • Assisting in development of inspection and ISO documentation as required .
  • Contributing to team efforts as needed.
  • Other duties as assigned.

Qualifications:

  • High School diploma
  • Lab or manufacturing setting work experience
  • Computer literacy desired

APPLY

The Planner II performs all functions required to ensure product availability while staying within the site’s total inventory target. This is a service position and is responsive to the needs of both internal and external customers. Primary responsibility centers on coordinating the manufacturing of finished product. Integrate forecast and order requirements using MRP to ensure product availability for the organization.  Planner II is responsible for the delivering appropriate plans to procurement to ensure raw material availability and to manufacturing to ensure finished goods availability to meet customer demands.

Responsibilities:

  • Knowledge of planning processes and forecast management
  • Provide support to higher levels of the supply chain organization
  • 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
  • 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

Qualifications:

  • Bachelors in Business or equivalent experience.
  • 2-5 year’s business experience
  • SAP and/or MAPICS is a +
  • Skilled in using ERP, Microsoft Excel, Word, Power Point, Outlook

APPLY

This position is responsible for all supply chain related activities including strategic sourcing, production planning, inventory control, and distribution for Repligen’s products. The Senior Manager is focused on ensuring product is delivered on time and in full through both distributor and sale channels. The incumbent will define and implement business processes to support corporate objectives in the areas of safety, cost, quality, and delivery. The Senior Manager is a dynamic service orientated leader who manages complex tasks independently and also leads cross-functional teams in a fast-paced environment.  The Senior Manager of Supply Chain is responsible for the availability of tools to enable appropriate plans to be generated.

The Senior Manager of Supply Chain 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.

Responsibilities:

  • Provide daily oversight of the supply chain function ensuring procedures and practices are compliant with global current good manufacturing practices (cGMP). 
  • Develop and implement supply chain approaches and strategies including sourcing of low cost materials, supplier performance, production schedule adherence, inventory accuracy, and capacity planning. 
  • 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.
  • Implement supplier agreements/contracts when beneficial by working with cross-functional stakeholders and suppliers to reach agreement on contract terms and conditions. Negotiate best possible cost service guarantee and develop “win-win” strategies that achieve sustainable relationships with suppliers.
  • Develop and implement visual controls and measures, driving operational excellence from suppliers through the manufacturing process, includes, but is not limited to, supplier on-boarding and supplier audits. 
  • Collaborate across the company to achieve successful transfer and/or launch of new products and line extensions. 
  • Ensure processes and activities are compliant with current good manufacturing practices, relevant international regulations as well as OSHA and EPA requirements. 
  • Recruit and develop staff to execute department functions; ensure effective utilization of resources through consistent performance management, and rewards and recognition practices.
  • Leadership/Teamwork/Contacts
  • The Senior Manager of Supply Chain 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.

Qualifications:

  • Bachelors in Business or equivalent experience.
  • 6-10 year’s business experience
  • SAP and/or MAPICS is a +
  • Skilled in using ERP, Microsoft Excel, Word, Power Point, Outlook

APPLY

IRVING, TEXAS, USA

     No current openings.

LUND, SWEDEN

     No current openings.

RAVENSBURG, GERMANY

     No current openings. 

FIELD

     No current openings.

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