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

The successful candidate will be responsible for providing Process/Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. Provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Support the review and release of the XCell™ ATF single-use product line.

Responsibilities: 

  • Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectations (e.g., Quality System Regulation, ISO standards, ASME BPE, etc.). Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
  • Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
  • Ensure the development and validation of appropriate test methods for product and process performance
  • Ensure active and thorough investigation of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints)..
  • Support the XCell™ATF single-use product line through the review of batch records and lot release.
  • 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. This individual will also assume 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
    • Identify 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
  • Effectively utilize Lean and Six Sigma methodologies as appropriate to achieve optimal results

Qualifications: 

  • At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).
  • Understanding of basic chromatography, fermentation and purification (production and lab scale) is required for this position
  • Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
  • Minimum 5-7 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent

APPLY

This role coordinates daily activities of the documentation staff within the QA department. Ensures new and existing publications are in accordance with established documentation procedures. Ensures any necessary internal process documentation is generated and executed in a timely manner. Relies on experience and judgment to plan and accomplish goals. Promotes continuous improvement.  Performs a variety of tasks.

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.
  • Maintains related database systems including managing a record retention program, label and batch record issuance, EDMS (electronic document system) and training database.
  • Assists in the implementation of QA policies and procedures; adheres to policies and procedures when performing daily tasks
  • Regularly meets with the manager to resolve issues, maintains time lines and plans in order to meet the company’s needs in the area of document control.
  • Ensures the document control system is efficient and meeting the manufacturing turnaround times.
  • Maintain routine document control activities of document revision, batch record generation and label generation in support of the Repligen production schedules
  • 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

Qualifications: 

  • Requires college level education and 4-8 years’ experience in an ISO 9001 environment with working knowledge of documentation functions
  • Strong knowledge of Microsoft Office, including Word and Excel and Adobe Pro.
  • Experience with electronic Document Control and Training systems.
  • 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

APPLY

Repligen is looking for a licensing and contract professional to help drive the company’s corporate business licensing and expand our bioprocessing product portfolio through M&A, licensing, collaborations, distribution, and OEM agreements.  This person will work directly with leaders from across the company including Research and Development, Business Development, Product Management, Sales, Marketing, Finance, IR and Operations as well as with external legal counsel and our partners.

Responsibilities:

  • Lead and manage the activities associated with all contract structure and design
  • Conduct deal negotiations for supply, co-development, OEM, distribution, confidentiality, and material transfer agreements.
  • Review and analyze complex business issues to make recommendations on commercial contractual topics
  • Support Research and Development, Marketing and Product Development along with  external legal counsel to file and support patents, copyrights and trademark filings
  • Communicate current and upcoming licensed deals with department heads and corporate officers along with our licensees.

Qualifications:

  • Demonstrated experience in not only negotiating licenses and contract agreements but experience with long-term follow up of ongoing agreements
  • Experience in partnership building, structuring and negotiating deals, and implementing a variety of transactions with life science companies including intellectual property review
  • Strong conversational, presentation and written communication skills
  • Ability to function productively as a team member and follow-through with partners
  • Minimum of 5 year’s life science experience.

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 testing. This person will also be responsible for documenting all work in production batch records; tracking data in Microsoft Excel and creating SOP’s in Word; operation of laboratory equipment (including pumps, Multi-meters, power tools, hand tools, pressure tanks, and various gauges/sensors) and operation of manufacturing equipment.

Responsibilities: 

  • 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 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

  • Minimum of an A.S. in Technical discipline (e.g.EE Technology, Mechanical Technology, or Engineering, etc.) and 3-5 years relevant experience
  • Experience and/or willingness to work in a 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

SHREWSBURY, MASSACHUSETTS, USA

       No current openings

LUND, SWEDEN

       No current openings

WEINGARTEN, GERMANY

       No current openings

FIELD

Repligen is seeking a highly motivated and experienced salesperson 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 - principally monoclonal antibodies - to new and existing Biopharmaceutical customers across a territory spanning the North of Germany, the Nordic Countries and Baltic states. 

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 Sales Director, Europe, this is a home office based role.

The ideal candidate will have an excellent working knowledge of English and German.

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 8+ years of experience in the biopharmaceutical or life science industries. A strong understanding of Cell Culture and filtration is a priority. However, additional skills and understanding and downstream processing would also be beneficial
  • Proven sales track record and key account management experience
  • Proven ability to build mutually beneficial 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, and strong organizational skills

APPLY

We are seeking a Field Application Scientist to technically support the TangenX® product line in Europe.  This individual will use their knowledge of downstream process development, filtration and bioprocess 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 Development 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 travel within Europe and occasionally outside of 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® TFF product line.   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.
  • Provide knowledge and customer feedback to Product Management and R&D for the continuous improvement of Repligen products.
  • Contribute to applications data and collateral generation by liaising with R&D.

Qualifications: 

  • A Bachelors degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field.
  • 5+ years’ experience working in a downstream purification discipline in a development or manufacturing setting in the bioprocessing industry.  Relevant experience in the development of harvest clarification and UF/DF unit operations.  Working knowledge of cGMP requirements.
  • Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required.
  • Strong problem solving and analytical skills.
  • Ability to manage yourself 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% travel within Europe and occasionally outside of Europe.

APPLY

We are seeking a Field Application Scientist to technically support the XCell™ ATF product line in Asia.  This individual will use their knowledge of cell culture process development, filtration and bioprocess manufacturing to support customers and our sales team in pre and post sales opportunities.

The successful candidate will also work closely with Repligen colleagues in the US and locally and with distributors in the region.  The candidate will interface with Sales Account Managers, Product Management, and Service 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 travel.  It is preferred that the candidate is based in Shanghai. 

Responsibilities: 

  • Work in coordination with the Repligen Sales team, local distributors and Product Management to provide pre and post-sales support to customers for the XCell ™ ATF product line.   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.
  • Provide knowledge and customer feedback to Product Management and R&D for the continuous improvement of Repligen products.

Qualifications: 

  • A Master’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 setting in the bioprocessing industry.  Working knowledge of cGMP requirements.
  • Excellent interpersonal skills, strong verbal/written communications skills and attention to detail are required; Strong English speaking skills
  • Strong problem solving and analytical skills
  • Ability to manage yourself 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
  • 50% domestic travel with limited international travel

APPLY

Repligen is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Repligen provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran.

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