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

WALTHAM, MASSACHUSETTS, USA - HEADQUARTERS

The successful candidate will be responsible for assisting the QA Document Control department revise/create, file, organize, and review production documents. The candidate will work closely with the Manufacturing team and Document Control department to ensure the changes are accurate and are made effective in a timely manner.    

Responsibilities:  

  • Works with subject matter experts, area managers and QA-Compliance personnel to properly convert documentation into the final written form and ensure the appropriate document approvals are obtained prior to documentation becoming effective
  • Prepares and publishes approved documentation in a timely manner to meet established deadlines (electronic)
  • Supports Electronic Training System (Training and Development module)
  • Maintains related database systems, logs and complete forms/records as required
  • Adheres to written policies and procedures related to performing assigned tasks
  • Assists in the implementation of QA policies and procedures; adheres to policies and procedures when performing daily tasks
  • Regularly meets with the team to resolve issues, maintains time lines and plans in order to meet the company’s needs in the area of document control
  • Files and performs other organizational tasks
  • Organize and update training files as necessary to maintain compliance
  • Copy, scan, and file records appropriately
  • Maintain routine document control activities of document revision, batch record generation and label generation in support of the Repligen production schedule
  • Detail-oriented with the ability to multitask in a fast paced environment
  • Team player with ability to collaborate with others
  • Customer driven with sense of urgency/priority in responding to customers' needs (internal and external)
  • Ability to shift priorities to support business needs
  • Must be a self-starter with the ability to work independently
  • Ability to exercise good judgment and be able to make decisions within prescribed guidelines
  • Other duties as assigned

Qualifications:  

  • Requires college level education and 1 - 2 years’ experience in an ISO 9001 environment
  • Strong knowledge of Microsoft Office, including Word and Excel. Experience in Electronic Documentation Management Systems. Experience with Electronic Training Systems and MS Access a plus
  • Excellent organizational and communications skills                                
  • Must be resourceful and self-motivated
  • Team player with ability to collaborate with others
  • Strong verbal, written and interpersonal communication skills
  • Working knowledge of documentation functions within a cGMP or ISO regulated environment is preferred

 APPLY

Our OPUS® Pre-packed Column product line is experiencing tremendous growth. We are currently seeking an experienced Customer Service professional to support this complex custom made product worldwide. 

The successful candidate will be responsible for serving as the OPUS® Customer Operations Senior Analyst and customer advocate while ensuring best practice service and support from Repligen is delivered. They will provide support of the customer for the lifecycle of the OPUS order; from receipt of the customer’s purchase order through the various activities for order management, fulfillment, resin pick up (if required) delivery and post- delivery support when required.

Responsibilities:  

  • As a member of the customer service team, the OPUS Order Support Sr. Analyst will provide seamless project coordination, customer service and support of Repligen’s global customer’s inquiries and orders:
    • Supporting customer products and unique account requirements
    • Executing the OPUS Resin Pick-up Service coordination when required  
  • Responsibility for the lifecycle of the OPUS custom order utilizing; 
    • Salesforce.com as a coordination tool from purchase order receipt to post-delivery issue resolution
    • Great Plains Dynamics ERP system for order transaction to invoice
  • Serve as the Customer’s advocate by coordinating and communicating  internal and external communication, activities and resolution
  • Partner with product management, supply chain and distribution to ensure the downstream process of pick, pack, ship and deliver is executed to the customer’s expectation
  • Facilitate the launch of the complaint process with customers by providing the documentation and escalation required internally for resolution with Product Management, Quality, Manufacturing, Supply Chain and the Sales team.

Qualifications:  

  • Bachelor’s Degree or equivalent required
  • Demonstrated passion for providing excellence in the customer experience
  • 4+ years’ experience in global customer service/order management with a strongly developed commitment to client services
  • 2+ years working with ERP systems, experience in Salesforce.com a plus
  • Life Sciences industry experience preferred
  • Supply chain, logistics or contract administration experience a plus
  • Project management experience desired; ability to manage multiple customer projects at different stages of completion 
  • Understanding of import/export/trade compliance requirements globally
  • Understanding of revenue recognition requirements for a publically held company
  • Experience in an ISO9001 quality system a plus
  • Outstanding attention to detail and strong organizational skills
  • Exceptional analytical skills
  • Ability to organize and manage multiple priorities with multiple stakeholders
  • Excellent verbal and written communication skill required for internal and external purposes
  • Comfort working in a fast-paced, small company environment
  • Bachelor’s Degree or equivalent required

  APPLY

The successful candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner.    

The Quality Assurance Associate I will actively participate in the Repligen ISO 9001 Quality Management System and will be responsible for the review of production and Quality Control batch records. The ideal candidate will have knowledge of chromatography column packing processes and an understanding of analytical techniques (pH and conductivity), and basic microbiology (bioburden and environmental monitoring). 

Responsibilities:  

This position involves completing the QA review of production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing chromatograms. Ability to identify process deviations, assist with the writing of root causes, and identification of corrective actions to prevent recurrence, is highly preferred.

Additional responsibilities involve:

  • Review of supporting data for production activities, such as, environmental monitoring, Reverse Osmosis Deionized water, cleaning logs, and controlled temperature chamber logs.
  • Perform various administrative functions, such as, label generation, binding, and filing of production records.
  • Perform batch record review; to include production, monthly RO/DI, weekly Environmental Monitoring records, and weekly/monthly logs
  • Identification of process deviations, corrective actions
  • Identify out of trends and out of specifications for product
  • Verify labels generated by Document Control 
  • Bind and file completed batch records

 APPLY

This role reports directly to the Director of Information Systems and is a proven professional, responsible for all technical and operating aspects of IT operations and infrastructure for Repligen’s global business. This includes managing, developing and maintaining the global IT infrastructure and operations covering Repligen’s global locations.

The IT Operations Manager works closely with all parts of the global organization and is responsible for improving, securing and establishing systems, infrastructure, controls and works effectively, cross-functionally, in a rapidly changing environment. The position requires travel to Repligen’s locations globally.

Responsibilities:

IT Operations

  • Establishes and maintains a service oriented culture for all operational, support and project responsibilities drive by data and KPI measurements.
  • Ensures defined SLAs are met and a culture of continuous improvement is maintained.
  • Administration and leadership of Repligen’s Server Infrastructure components, including but not limited to:
    • Cloud infrastructure (Office 365, AWS, Azure, Private Cloud)
    • Citrix and VMware technologies 
    • Microsoft Windows Server and Active Directory environment
    • Enterprise disaster recovery systems
    • Dell EqualLogic SANs, 802.1x gigabit switched networks, IPsec VPNs and SonicWALL firewalls
    • Cisco Meraki wireless Aps.
  • Monitors server and network infrastructure for performance, security, and integrity using industry standard utilities and monitoring tools.
  • Perform information assurance activities: patching, scanning and documenting vulnerability remediation plans.
  • Assist in the design, administration, monitor and security on a distributed network across multiple  locations.
  • Directs and collaborates with internal personnel and external consultants to drive and oversee IT infrastructure project development and implementation
  • Develop and maintain IT systems documentation and procedures

Security

  • Leads Cyber Incident Response Team as part of the Information Security policy – ensuring compliance and education of the organization.
  • Ensures compliance with all PCI as well as other regulatory or industry standards.
  • Assesses risks, events and ensure best practices are utilized.
  • Ensures compliance in staff education on Information Security Awareness.

Management

  • Establishes and maintains controls and adherence to policies within the organization through ITIL and ISO frameworks.
  • Leads and participates in release management.
  • Manages help desk through key performance indicators and sets client first mentality within the team.
  • Provides leadership and guidance to plan, hire, coach, motivate, and lead the team to their optimum performance levels and career development.
  • Documents process and architecture narratives; documents, corrects and communicates any variances from defined standard; identifies and recommends material improvement opportunities for management.
  • Coordinates the activities of the Server Infrastructure and Help Desk teams to resolve issues, focus efforts, identify and prioritize needs, develop project justifications, IT budgets, schedules and resource plans.
  • Monitors trends, research and propose new solution which would benefit the company.

Qualifications:

  • BS in Computer Science, Engineering, Management or related discipline required 
  • Requires 7+ years IT management experience (preferably in a biotechnology or pharmaceutical environment)
  • Requires experience with state of Massachusetts data security requirements (201 CMR 17.00), and PCI compliance
  • Requires administration/support experience in Microsoft Windows server 2008 & 2012, Active Directory, Exchange, Office 365,  SQL Server, IIS, VMware ESXi, and Citrix XenApp
  • Requires previous experience with WAN and LAN technologies, preferably SonicWall NSA firewalls, Meraki wireless APs, Dell managed switches, Citrix Access Gateway, iSCSI SANs, Avaya IP Office telephony, VLANs, and 802.1x networking
  • Requires previous experience with server, storage and network hardware, preferably Dell PowerEdge, PowerConnect, and EqualLogic
  • Requires previous experience in multi-platform network environment (Windows/Mac OS/Linux clients and servers)
  • Requires a broad understanding of information systems technology and a solid understanding of the appropriate application of various technologies to business operations and system life cycles
  • Additional requisites include: strong organizational and interpersonal skills, a process oriented mindset, strong problem solving and analytical skills, ability to work independently & collaboratively, results-oriented attitude with ability to prioritize, and a talent for interacting with people at all levels

Knowledge and Skills

  • Expert at implementing and maintaining high available on premise and cloud environments.
  • Expert at designing, configuring, implementing and supporting enterprise level systems.
  • Strong troubleshooting experience with infrastructure architectures and web based applications in a production support capacity required.
  • Exceptional multi-tasking skills. Ability to organize and executive on multiple high priority tasks simultaneously.
  • Demonstrate expertise working independently as well as in teams to research, test, and implement new software and hardware solutions, and successfully managing projects to completion.
  • Expertise to manage and administer corporate infrastructure consisting of Knowledge of ITIL, COBIT, ISO or similar standards.
  • Knowledge of agile project management principles.
  • Strong written and oral communication skills.
  • Excellent problem solving and listening skills.
  • Attention to detail and exemplary customer service skills are essential.
  • Sets and example in terms of quality, consistency and level of work, as well as work ethic and approach.
  • Highly motivated, self-starter, with a positive attitude.

 APPLY

This position is for the 2nd shift in the Protein Purification group, however; cross training into other departments may be required.  The successful candidate will play a key role in ensuring that the department’s production and quality goals are met. Applicants must have strong technical knowledge and problem solving skills. The candidate must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner. Experience working in a GMP/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 and must be able to work overtime.

Hours are 4 p.m. to 12 a.m.

Responsibilities:  

  • Large scale column chromatography 
  • Product recovery using tangential flow filtration
  • Large scale buffer/media preparation
  • pH precipitation
  • Sterile filtration
  • Aseptic liquid fill/finish
  • Equipment cleaning (CIP/SIP)
  • Chromatography column packing
  • Timely and accurate completion/review of production documentation
  • Entry of in-process data into trending databases
  • May be required to cross train into fermentation and/or chromatography column packing departments

Qualifications:  

  • BS degree in biological sciences, or a related field preferred, or a minimum of two years experience in biotech manufacturing
  • Experience in protein purification is preferred
  • Excellent organizational and communications skills                                
  • Must be resourceful and self-motivated
  • Must be willing to work overtime (including evenings and weekends) as required
  • Must be able to lift 50 lbs unassisted

 APPLY

Repligen is seeking a scientist or engineer to develop applications for existing and new products in development with a focus on cell culture based technologies. This is a position residing within a multidisciplinary Research and Development group, a team of scientists and engineers designing new products and processes.

Responsibilities:  

  • Perform experiments to develop applications for new and existing products. Laboratory activities will include mammalian cell culture, bacterial fermentation, membrane based clarification and protein purification projects using chromatographic separation methods
  • Developing a thorough understanding of bioprocess unit operations for use in rapid process optimization
  • Actively participate in new technology development projects resulting in novel methods and unit operations that would add value to the bioprocessing industry
  • Designing experimental investigations,  analyzing experimental data, new findings, literature review, submitting technical reports, and giving presentations internally  and in 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 inter departmental discussions
  • Working with other departments including manufacturing, project management and sales to accomplish individual and company objectives

Qualifications:  

  • Degree in chemical engineering, biochemistry or biology. BS with at least 5 years or MS with at least 2 years of industrial experience in a process or applications development setting
  • Extensive understanding in biological process sciences, both upstream and downstream including aseptic techniques, cell culture processes, protein analytics and chromatographic techniques 
  • Experienced hands-on work setting up lab scale bioreactors, culturing cells and performing process optimizations
  • Additional experience with perfusion based cell culture processes, Tangential flow filtration (TFF) and Chromatographic based protein separations would be a strong plus
  • Demonstrated experience in 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 inter personal skills to communicate with internal and external team members

APPLY

Repligen is a trusted and forward-thinking partner in the production of biologics that improve human health worldwide, committed to supporting our customers with superior technology, service and applications expertise. We are executing on a focused growth strategy that involves ongoing innovation and collaboration, targeted acquisitions and commercial expansion. 

Responsibilities:

  • Provide coaching and guidance to managers regarding personnel management issues, including performance management, training, and organizational development and structure. Oversee and provide assistance with performance reviews, performance improvement plans and job descriptions.
  • Formulate and recommend HR/people related policies, procedures and objectives for the organization to senior management. Lead team to implement changes.
  • Work with hiring managers on new staff requisition requirements, including role specifications and profile requirements.
  • Team with internal interviewer to help foster positive interviewing techniques. 
  • Establish effective on-boarding and off-boarding policies and practices. Ensure consistent implementation across the organization and follow through. 
  • Monitor organization compliance with federal and state laws (including FLSA, ADA, FMLA, MMLA, EEOC, ERISA, etc.). Ensure the Employee Handbook is up-to-date, reflecting current practices, laws and regulations. Directs the preparation of information requested or required for compliance, including all 5500 Form filings, 401(k) audit, workers compensation and summary annual reports. Act as a primary contact with labor counsel and outside government agencies.          
  • Manage the development and implementation of training and development programs for all staff. Identify internal needs and oversee relationships with external resources to provide necessary education and materials to management and staff.
  • Develop, implement and manage staff recognition programs.
  • Other duties as assigned with or without accommodation
  • Occasional travel may be required 

Qualifications:

  • Minimum of 8 years of experience in the HR field, preferably within a life sciences organization, demonstrating increasing levels of responsibilities.
  • BS/BA degree
  • SPHR/PHR preferred 
  • Experience with HRIS
  • Demonstrated experience rolling out HR programs, initiatives
  • Experience in mergers and acquisitions, integration and change management 
  • Experience in a global, multi-site environment

 APPLY

SHREWSBURY, MASSACHUSETTS, USA

Repligen acquired TangenX™ Technology in Shrewsbury, MA in December 2016.   TangenX offers a complete line of both single use and reusable tangential flow cassettes that complement our product portfolio.

We have an opening for a Quality Assurance Manager at the TangenX site in Shrewsbury, MA.

Responsibilities:

  • Provide and lead quality compliance through training; foster a quality-oriented culture
  • Manage the Quality Documentation system and archival process, maintain employee training forms
  • Manage the daily Quality activities of finished membranes and cassette products from incoming raw material release through batch record review and release of finished goods.
  • Lead/administer audits of systems, processes and products to ensure compliance with ISO and customer requirements and compliance to the Quality System. Participates in and/or hosts third party audits
  • Maintain critical supplier qualification and evaluation program including annul critical supplier evaluations
  • Monitor the complaint handling process through maintenance of complaint handling requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable
  • Set up and oversee product related deviations, CAPAs and participate in development of corrective action plans
  • Coordinate/track/drive closure of audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner
  • Design, compile, analyze, trends and issue QA performance metrics reports. Present summaries to the senior management team during Management Review
  • Review and or approve IQ/OQ and Validations of critical processes and equipment
  • Manage and develop QA staff members; plan and implement QA resources to support quality related activities
  • Write and implement standard operating procedures and work instructions for QA actions
  • Write and revise purchase specifications for critical raw materials
  • Complete customer questionnaires, surveys, and review customer Confidentiality and nondisclosure agreements
  • Issue copies of quality certificates upon customer request

Qualifications:

  • BS/BA degree
  • 5-7 years related QA and Quality Management Systems experience required
  • Strong understanding of ISO 9001 requirements is required
  • Able to lead a group and work independently, without instruction
  • Experience leading Quality audits both internally and externally is preferred
  • Excellent cross-functional team participation skills
  • Highly organized and detail-oriented
  • Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software

APPLY

RANCHO DOMINGUEZ, CALIFORNIA, USA

The Accounting Manager works closely with all parts of the organization and is a leader in Repligen’s Rancho Dominguez accounting department. Responsibilities include the financial close, financial reporting, revenue recognition, accounts receivable, accounts payable, payroll, etc. This role will manage three individuals.

Responsibilities: 

  • Oversee the Company’s general ledger, credit and collections, and accounts payable functions and assist in identifying and driving best practices into the functions
  • Analyze expenses to ensure they are recorded appropriately on a monthly basis
  • Facilitate and complete timely monthly, quarterly and annual closes
  • Prepare and review account reconciliations and analyses
  • Assist with the consolidation of all subsidiaries
  • Assist in preparation of support for the parent Company’s SEC filings
  • Lead and support quarterly attest reviews and annual audits as required
  • Drive compliance of SOX controls and support the implementation of new processes to enhance the Company’s control environment
  • Monitor and ensure the timely identification of evolving accounting guidance and potential impacts on the company. Partner with operations to develop and implement operational changes, as required
  • Provide technical and hands-on implementation support for merger and acquisition activity, as required
  • Perform special accounting analysis and projects, as requested

Qualifications: 

  • Bachelor’s degree or higher in Accounting or Finance
  • 4-8 years of accounting experience required
  • Public accounting experience required (Big 4/National CPA firm preferred)
  • CPA license preferred
  • Strong knowledge of U.S. GAAP, including complex topics and areas
  • Highly detail oriented and organized in work
  • Self-starter with ability to manage work autonomously
  • Ability to multitask and meet assigned deadlines
  • Familiar with ERP software as well as accounting/auditing principles
  • Proficient in advanced Excel functions
  • Ability to work cooperatively and collaboratively with all levels of employees, management, and external agencies to maximize performance, creativity, problem solving, and results

 APPLY

Responsibilities:

  • Perform weekly check run
  • Perform A/P close at month-end
  • Research unpaid old invoices; answer calls from vendors; work to resolve billing discrepancies
  • Coordinate with all departments on invoices billed and approved to pay
  • Ensure invoices are paid in a timely manner
  • Process annual 1099 forms
  • Reconcile vendor statements to Accounts Payable reports
  • Ensure employee expense reports are approved by respective managers
  • Other duties and projects as assigned
  • Verify items billed against actual items received; match Purchase Order and invoice codes; input into respective segment

Qualifications:

  • Associate’s degree in Finance or Accounting; Bachelor’s degree preferred with 2- 3 years' experience
  • Experience with SAP. SAP By Design a plus
  • Excellent oral and written communication skills
  • Ability to work independently with minimal supervision

 APPLY

IRVING, TEXAS, USA

Our manufacturing facility located in Dallas, TX, designs and develops Medical Devices and surgical commodities. Our products that are sold worldwide include Orthopedic Softgoods and positioners, as well as custom designed devices and drapes for cardiac, neurology, endoscopy and robotic assisted surgery. The Production Manager role is located in Dallas and includes team collaboration to help deliver these innovative turnkey solutions, components and finished devices at greater efficiency and lower cost. 

Responsibilities:

  • Manage Dallas Production plant activities
  • Manage 20 production workers and 1 non-production
  • Interviewing, hiring, training and evaluation of plant employees. Handling employee issues, complaints, manage time cards, work schedules and incentive pay.
  • Plans and schedules production for manufacturing
  • Issue work order numbers; data entry into Matrix system
  • Source, schedule, purchase raw materials and production related supplies; Data entry of all PO’s and Receivables
  • Finished goods lot number tracking
  • Coordinate shipping and warehousing of raw materials and finished goods
  • Overall responsibility of maintenance, production, sterilization scheduling and paperwork, shipping and receiving, production employees, raw material and finished goods inventory levels, counting, etc.
  • Returned Goods – assign RGA number, keep records and evaluation
  • Control of part and product numbers
  • Member of Management Review Committee for quality policy objectives
  • Provided Certificate of Conformance and shipping paperwork to customers

Qualifications

  • 5 years’ experience in all areas:
    • Production
    • Sourcing
    • Scheduling
    • Daily interaction working directly with plant employees
    • Completing work travelers
    • Handling customer complaints
    • Assisting OEM/PL customers
    • EDC (electronic data capture) and CRM computer data input
    • Knowledge of ‘SAP Business by Design’ or similar ERP system helpful

APPLY

LUND, SWEDEN

     No current openings.

RAVENSBURG, GERMANY

This position will function in Repligen's Pre-packed Column Packing groups. The successful candidate will play a key role in leading the department's production and ensuring that all quality goals are met. Applicants must have strong technical knowledge and problem solving skills and must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.

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

Responsibilities:

  • Lead and supervise all production personnel involved in the manufacture of pre-packed columns
  • Develop a production schedule based on customer demand and forecasts.
  • Manage the daily execution of the production plan
  • Effectively respond to changes to the schedule and communicate those changes both to the manufacturing team as well as to management
  • Responsible for the timely and accurate completion/review of all production documentation
  • Ensuring that all employees are trained to perform their functions and have personal development plans
  • Ensure that the operation is in compliance with all aspects of Repligen's IS09001 Quality Management System
  • Responsible for keeping all manufacturing and testing equipment clean and calibrated
  • Responsible for insuring that work area is clean and safe 
  • Individual must communicate daily/weekly status of the operation by reporting on metrics, KPI’s to the group and to management
  • Work cross functionally with supply chain and quality to insure material availability and efficient release and shipping

Qualifications:

  • BS degree in Science or a related field preferred, but candidates without a BS degree will be considered with three to five years' experience in Biotech manufacturing
  • Familiarity with SAGE/GP or similar ERP systems to effectively account for production and inventory is a plus
  • Experience in column chromatography is preferred
  • Experience with the operation of laboratory equipment (including pumps, UV detectors, and various gauges/sensors) and operation of process-scale manufacturing equipment
  • Excellent organizational and communications skills
  • Must be resourceful and self-motivated

 APPLY

FIELD

     No current openings.

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