Process Development Engineer II - Synthetic and Bioconjugation Scale-Up Technologies (SBST)

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); On-site; USD 110,000 - 150,000; Full time

Job summary

Regeneron seeks a Process Development Engineer II for its PMPD group in Tarrytown, NY. You will design and develop scalable GMP-ready bioconjugation and purification processes while collaborating to apply QbD principles and support tech transfer to CDMOs.

This role requires a Bachelor’s degree with 5–6 years or a Master’s with 3–4 years in chemical/biochemical engineering, experience with antibodies, bioconjugation, downstream purification, and analytical tools like HPLC, MS, and

Qualifications

• Bachelor’s degree with 5–6 years or Master’s with 3–4 years in chemical/biochemical engineering or related field.
• Experience with bioconjugation processes and downstream purification techniques.
• Experience with analytical tools: HPLC, MS, electrophoresis, UV spectroscopy.
• Familiarity with DOE and QbD in GMP settings.
• Strong communication and cross-functional collaboration.

Responsibilities

• Design and develop scalable GMP-ready bioconjugation and purification processes.
• Collaborate with analytical groups to establish analytic characterization techniques.
• Discuss plans in cross-functional teams to evaluate processes and goals.
• Proactively comply with lab safety and regulatory expectations (FDA/DoT).
• Use DOE to optimize bioconjugation, purification, and analytics.
• Transfer processes with CDMOs for GMP production with first-time success.
• Develop new technologies and predictive process models; author docs.
• Mentor junior team members and present data for decision making.

Skills

Bioconjugation

DOE

Data presentation

Education

Bachelor’s degree in chemical/biochemical engineering

Master’s degree in chemical/biochemical engineering

Tools

Chromatography

Ultrafiltration/Diafiltration

Membrane technologies

Electrophoresis

Mass spectrometry

HPLC

UV spectroscopy

Job description

Build our future together:

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, NY

Work 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

Does this sound like you?

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue ha