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
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.
- 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
- 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
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.
- 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
- 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
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.
- 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
- 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
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.
- 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.
- 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
- Experience implementing a variety of transactions with life science companies including intellectual property review
- Very 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
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.
- 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
- 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
No current openings
This role reports directly to the Corporate Controller and is a proven professional, responsible for all technical and accounting operations for Repligen’s German site. This includes developing people, improving processes and controls and working effectively, cross-functionally, in a rapidly changing environment.
The Site Finance Manager works closely with all parts of the German organization and is responsible for the financial close, financial reporting, revenue recognition, accounts receivable, accounts payable, payroll, etc.
- Manage monthly, quarterly and annual close processes
- Help implement and refine SOX controls at the Site
- Perform revenue, inventory and cost accounting work, in partnership with local customer service and operations teams
- Serve as the primary interface for external auditors in connection with financial reviews, attest audits and internal control reviews, including supporting schedules/reconciliations
- Partner with third party provider on tax provisioning, filings, payments, etc. to ensure compliance with local and national tax jurisdictions
- Work closely with financial planning and analysis team on reporting efforts related to budgeting and forecasting
- 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
- Perform special accounting analysis and projects, as requested
- Bachelor’s degree in Accounting preferred
- Strong knowledge of U.S. GAAP
- Fluent in English
- Multi-national company experience preferred
- Experience implementing SOX controls preferred
- Ability to organize and manage multiple priorities; deadline oriented
- Skill in problem analysis and resolution
- Excellent verbal and writing skills
- Hands on work ethic with strong attention to detail
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.
- 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
- 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
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.
- 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.
- 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