Join Our Team at Regeneron: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Process Development Engineer II to join our Preclinical Manufacturing & Process Development (PMPD) group, supporting the new Synthetic and Bioconjugation Scale-up Technologies (SBST) team. You'll develop conjugation and purification processes for bioconjugation of proteins to a diverse range of synthetic molecules, working closely with cross-functional teams to apply Quality by Design (QbD) principles that make processes suitable for GMP production. You'll also support process scale-up and technology transfer of manufacturing workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron-based manufacturing suites, helping ensure timely and reliable progress from clinic to commercialization. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & Where:
Location: Tarrytown, NYWork model/flexibility: Onsite, full-time
Discover Your Role:- Works at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes
- Collaborates with analytical groups within or outside the organization to establish supportive analytical characterization techniques
- Discusses plans and data in cross-functional teams to evaluate processes and determine developmental goals, ensuring integrated program success
- Proactively complies with lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as the FDA and Department of Transportation (DoT)
- Uses statistical design of experiments (DOE) to optimize bioconjugation processes, including conjugation reactions, purification operations, and analytical characterization
- Partners with the External Manufacturing group and other key partners at Regeneron's IOPS organization to provide technical assessment of CDMOs intended for GMP production, successfully transferring processes with immediate, first-time success
- Researches, identifies, and develops new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT)
- Authors robust technology transfer documentation and supports production with onsite presence during scale-up/GMP manufacturing activities
- Analyzes and presents data in a clear and cohesive manner to a broad audience, facilitating data-driven decision making
- Authors, reviews, or provides domain expertise for publications, reports, tech transfer documents, regulatory support documents, and patents
- Acts as a responsible lab citizen by ensuring timely maintenance of lab equipment, keeping the lab tidy and organized, and proactively planning for lab resources
- Coaches and mentors junior team members of the organization as needed
- This Role Requires:
- Bachelor's degree + 5-6 years relevant experience, or Master's degree + 3-4 years relevant experience, in chemical/biochemical engineering or a related field
- Experience with antibodies in the bioconjugates space is highly preferable
- Hands-on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific, etc.) with practical knowledge of downstream purification techniques such as chromatography, ultrafiltration/diafiltration, and membrane technologies is preferred
- Experience with a variety of analytical characterization tools such as electrophoresis, mass spectrometry, high-performance liquid chromatography (HPLC), and UV spectroscopy is preferred
- Strong initiative with the drive to complete challenging tasks and learn new technologies
- Strong fundamental understanding of protein purification and technology transfer principles
- Capable of multi-tasking and working both independently and in a collaborative, cross-functional environment
- Excellent interpersonal, verbal, and written communication skills
- Strong critical thinking and problem-solving skills
