This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the document control department in processing documentation requests. They will work closely with cross functional teams and within document control department to ensure the changes are accurate and are made effective in a timely manner.      The Document Control Associate I will report directly to the QA Manager.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for the Quality review of customer questionnaires, updating Quality Agreement Matrices and coordinating schedules between auditors and auditees.

This role is part of the global infrastructure team and you will be responsible for daily operations and continuous improvements. You may participate in various projects where you offer support or implement solutions, which involves interaction with local and European stakeholders. We believe you have a genuine interest in all parts of the IT infrastructure; software, hardware, databases and networks. 

This position will be remote based ideally within the Northern CA/ San Fran- Bay Area vicinity    Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.   The VPT Support Specialist is responsible for providing technical assistance and expertise to the C Technologies, Inc. (CTI)/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory technology developed and marketed by CTI/Repligen includes spectroscopy instrumentation most notably the SoloVPE variable path length UV/Vis spectrophotometer system. The system is sold primarily into the pharmaceutical and biotech industry and is commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing and quality assurance.                         The VPT Support Specialist will provide support both at CTI/Repligen and on site at customer locations. The type of support will include system qualifications (Installation, Operation and Performance (IQOQPQ), product testing, system maintenance and customer training. Delivering training and support will involve travel to customer locations both domestic and international. Training will be provided by CTI/Repligen.

This position will function in our OPUS Column packaging team located at our new production site in Breda. Our OPUS Columns are plug-in purification columns which saves time in the production process of pharmaceutical products. As a Process Operator you will play a key role in ensuring that the department's production and quality goals are met. You have strong technical knowledge and problem-solving skills. Our Process Operators 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. Ability to read engineering drawings and be familiar with process control software is also highly desirable. You must be willing and able to learn new manufacturing processes as the company grows and to work overtime when needed (including occasional weekends).

Our creative and energized engineering team is looking for an Principal R&D System Engineer to design and develop actuation and control systems for the Analytical Instruments business unit. The products involved are optical fiber based assemblies and instruments that are used in wide range of industries including medical devices, pharmaceuticals, science and technology, telecommunications, metrology and others.   This individual will play a key role in new product development projects. Responsibilities include research, design and development of new systems and devices which will be used to control, monitor and regulate Pharma or Biotech processes in Lab. or production environments. Additional responsibilities include overseeing test procedures, writing reports and making sure that the devices developed comply with quality standards and safety regulations.

This position will be remote based ideally within Maryland/ Gaithersbury vicinity.     Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.   The VPT Support Specialist is responsible for providing technical assistance and expertise to the C Technologies, Inc. (CTI)/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory technology developed and marketed by CTI/Repligen includes spectroscopy instrumentation most notably the SoloVPE variable path length UV/Vis spectrophotometer system. The system is sold primarily into the pharmaceutical and biotech industry and is commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing and quality assurance.                         The VPT Support Specialist will provide support both at CTI/Repligen and on site at customer locations. The type of support will include system qualifications (Installation, Operation and Performance (IQOQPQ), product testing, system maintenance and customer training. Delivering training and support will involve travel to customer locations both domestic and international. Training will be provided by CTI/Repligen.

This position is responsible for the day-to-day activities involved with the Repligen ISO 9001 Quality Management System.

Repligen is one of the fastest growing bioprocessing tools provider in the life sciences industry. The growth is fueled by an industry leading portfolio of innovative products like  XCell ATF™ single-use cell retention systems, TFDF™ integrated clarification systems, OPUS® pre-packed columns, Spectrum® Hollow Fiber Filters and TFF systems, TangenX™ Flat Sheet Cassettes and ProConnex® Flow Paths enabling single-use bioprocessing in the monoclonal antibodies, recombinant proteins and vaccines manufacturing market . With the significant growth in the number of new candidates in the gene therapy development pipeline, Repligen is uniquely positioned to offer bioprocessing solutions that help optimize process development and manufacturing workflows and help reduce time to launch these life-saving therapies. We are searching for a Director of Business Development in a commercial leadership role for Repligen's Gene Therapy team in North America. The Director of Business Development will be responsible for developing the commercial strategy and a pipeline of new opportunities focusing in the field of gene therapy.

This individual will work closely with Process Engineering team to help assist in equipment commissioning, qualification and validation, including process improvement projects. The successful candidate will play a key role in supporting the projects in an assist role.  The applicant will be the key interface between manufacturing, R&D and QC.  Hands-on mechanical aptitude and an exceptional problem-solving ability are important.

This position is in Repligen’s Affinity Ligands group. The successful candidate will be responsible for the team’s production and quality goals. Applicants must have strong technical knowledge and problem-solving skills. 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/ISO/document-controlled environment would be beneficial. Leadership skills, 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.

As the marketing manager for bioprocess upstream technologies, you will lead strategic positioning and asset creation for the upstream business unit at Repligen. Today, the product lines include ATF and TFDF.  You have experience in bioprocessing with a natural ability to craft a compelling story or are a great writer marketing storyteller who devours technical information through complete immersion.  While hands-on experimental work is not a primary responsibility, you should be willing to roll your sleeves up if required. This role will report to the Director of Strategic Marketing.  Inspiring creativity, strong writing skills and the ability to rapidly learn technical information will be essential for success.

Repligen is a bioprocessing-focused life sciences company bringing over 30 years of expertise and innovation to our customers.  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.    Our business continues to grow and develop resulting in the expansion of our team.

Part of the US Accounts Payable Team, with primary responsibility for managing the Accounts Payable function in Waltham, MA. The Accounts Payable Specialist will liaise with both internal and external contacts to ensure the timely and accurate processing and payment of purchase invoices and respond to queries from vendors.

  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 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 preferred position will be based in Korea

This position will function in Repligen's OPUS Column Packing groups. Cross training into other departments may be required based on the changing needs of the department. 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. Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.   Schedule: Monday through Friday, 7AM - 3PM

This position will function in Repligen's OPUS Column Packing groups. Cross training into other departments may be required based on the changing needs of the department. 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. Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.   Schedule: Monday through Friday, 11PM - 7AM

The HR Business Partner will be responsible for providing HR support to our Rancho Domingo, Simi Valley, Anaheim and Irving, TX manufacturing locations.   This is a highly visible, hands-on role that will provide the opportunity to collaborate and act as a trusted, partner to site leadership by providing proactive HR leadership, consultative services to leaders and program/project execution.    

Repligen is seeking a New Product Development Engineer – I/II to join the New Product Introduction (NPI) engineering team in the R&D group located in Waltham. In this role you'll support New Product Development  for our ATF and OPUS products.  This successful candidate should have some product development experience and a willingness to work with and contribute to a group environment. The group work will involve other engineers and scientists from R&D as well as individuals from Product Management, Manufacturing, Quality, and Process Engineering. The ideal candidate is an experienced engineer, capable of overseeing both the implementation of design and process changes, driving new product development projects to completion.   This candidate should be both creative and possess good engineering prowess to make sound decisions regarding component design/design for manufacturability/design for assembly and materials of construction. Types of work include new product development, project/ engineering management, prototyping and testing, creating and executing validation protocols, completing change orders/ change controls, creating 2D/3D drawings, concept layouts and leading design reviews.   - The Mechanical Engineer will lead the design and development of new and legacy products, along with qualification and all stages of Repligen NPI process - Participate in planning, designing, documentation, and manufacturing transfer of complex systems - Create complete engineering drawing packages for new and existing products as required - Manage templates and standard PDM workflow, train others as needed - Lead design reviews of new products- components, assemblies and/or sub-assemblies - Work closely with Product Management, Manufacturing, and Quality Engineering to spearhead assigned projects and grow into a technical SME - Must have curiosity to solve problems, a strong drive to complete projects in a cross functional atmosphere - Ability to develop well documented, effective and clear project plans - Ability to make design and project decisions and communicate them upstream and downstream the organization - Lead and guide design verification and validation process, work closely with Sustaining Engineering and Applications R&D group to bring NPI projects to the finish line - Work under general supervision. Follow established processes and procedures. Self-motivated and positive attitude towards work - Should be open to learn along, adapt and improve - Interact regularly with Management to communicate status of milestones and impacts of technical or other challenges - Biotechnology/medical device/ Bioprocessing experience is a plus  

Overview This position is for the 3rd shift in the Bioprocessing group; M-F, 11P-7A. 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. 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 also to work overtime.