Execute new product development activities including process development, design verification, validation, scale-up, and technology transfer, taking ownership of deliverables and project outcomes.
Evaluate membrane formulations, process improvements, and emerging technologies to enhance product performance and manufacturability, bringing forward new ideas and approaches to technical challenges.
Design, execute, and analyze laboratory and pilot-scale experiments to address technical challenges, make informed decisions, and support project objectives.
Support validation activities using quality and manufacturing tools including DFMEA, PFMEA, IQ/OQ/PQ, control plans, and process verification methodologies, maintaining a strong commitment to quality, integrity, and compliance.
Prepare clear and accurate technical documentation, including development reports, characterization studies, validation reports, technology transfer packages, and SOPs.
Maintain a highly hands-on approach, spending significant time in the laboratory and pilot-scale environment developing processes, operating equipment, and troubleshooting complex technical issues with a strong sense of ownership and accountability.
Collaborate effectively with cross-functional teams, sharing knowledge and perspectives and working toward common goals to advance development projects and commercialization efforts.
Qualifications
Ph.D. in Chemical Engineering, Polymer Science, Materials Science, Chemistry, or related discipline with 2+ years of relevant industrial experience, or M.S. with 5+ years, or B.S. with 8+ years of relevant experience.
Experience in polymeric membrane development, membrane formation processes, and membrane separation technologies.
Experience supporting new product development projects, including process scale-up and technology transfer to manufacturing.
Familiarity with Stage-Gate product development processes, design verification and validation, and process validation activities.
Working knowledge of quality and manufacturing tools such as DFMEA, PFMEA, IQ/OQ/PQ, process characterization, and statistical analysis.
Strong experimental and troubleshooting skills with the ability to independently design and execute technical studies, make sound technical decisions, and take ownership of results.
Highly hands-on scientist/engineer who enjoys working in laboratory and pilot-scale environments.
Strong problem-solving, communication, organizational, and teamwork skills, with the ability to collaborate effectively, share ideas, and contribute to team success.
Demonstrated ability to manage multiple projects, prioritize effectively, and deliver results in a fast-paced environment while maintaining high standards of quality and accountability.
What Repligen Offers
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $113,000-$163,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
