Repligen Corporation (NASDAQ:RGEN) is a life sciences company and bioprocessing tools provider focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our products are developed under an ISO9001 quality management system and sold to major life sciences and biopharmaceutical companies worldwide. Our products enable customers to efficiently manufacture a broad range of biological drugs, including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies.  Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve global human health. Repligen is headquartered in Waltham, MA (USA), near the heart of Boston, with major manufacturing sites in Massachusetts, New York, California, Ireland, Sweden, and Germany.

• Working closely with commercial team, convert customer conceptual design into a product solution that meets customer applications need.  High concentration in Silicone and Thermoplastic manufacturing and development.
• Guide customer in selection of various raw materials that aligns with business preferred raw material.
• Generate finish product cost estimates for molded components, over molded tubing, extruded silicone and thermoplastic component finished goods.  Knowledge of tool design for Silicone, TPE’s and Thermoplastics.
• Design for manufacturability for silicone and thermoplastic overmolding and components.
• Basic knowledge of IQ,OQ, PQ’s and other validations.
• Product setup in ERP system which includes but not limited to creating Item Master, manufacturing router and Bill of materials.
• Initiate / Approve Engineering Change Orders for raw materials and finished products
• Building detailed raw material specifications which includes regulatory / compliance information, physical properties, application, sterilization, etc.
• Travel required <10 % of time to visit industry events and customer visit

• Minimum 2+ years of experience in designing Bioprocess Single Use products and applications or 2 years of designing Bioprocess Single use products with Bachelors degree in engineering
• Demonstrated ability to produce clear and accurate product drawings and manufacturing instructions 
• Competence with Solidworks is a must, and any prior working knowledge of with AutoCAD and PDM software will be a plus. 
• Prior hands on working experience with Silicone molding and extrusion is a must have.
• Ability to give feedback on tooling concepts and final designs being deployed to production

Other helpful Knowledge, Skills, Abilities 

• Proficiency in Microsoft Office, and prior working experience with ERP System and Quality management tool is desired. 
• A successful candidate will demonstrate or have strong skills in the following areas:
• written and verbal technical communication,
• interpersonal cross functional team based interaction,
• organizational and detail oriented, analytical, planning and problem solving,
• intellectual curiosity and a results oriented mindset.