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

Regeneron Pharmaceuticals, Inc; Village of Tarrytown (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron seeks a Process Development Engineer II to join its Preclinical Manufacturing & Process Development (PMPD) team in Tarrytown, NY. You will develop scalable bioconjugation and purification processes, apply QbD principles, and transfer technologies for GMP production.

You will collaborate with analytical, manufacturing and external partners, utilize DOE to optimize processes, and contribute to tech transfer documentation and regulatory support.

Qualifications

• This role requires a strong background in bioconjugation and purification.
• Hands-on experience with bioconjugation processes and downstream purification techniques.
• Experience with analytical characterization tools is preferred.

Responsibilities

• Design scalable, GMP-ready bioconjugation and purification processes.
• Collaborate with analytical groups to establish characterization techniques.
• Plan and data review in cross-functional teams to guide development goals.
• Ensure compliance with lab and regulatory safety standards.
• Use DOE to optimize bioconjugation, purification, and analytics.
• Support technology transfer to CDMOs and Regeneron manufacturing suites.
• Contribute to tech transfer docs and regulatory support materials.

Skills

Bioconjugation

DOE

GMP

Analytical methods

Education

Bachelor's degree in chemical/biochemical engineering

Master's degree in chemical/biochemical engineering

Tools

Chromatography

Ultrafiltration

Membrane technologies

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: On-site, 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

#pmpd

Does this sound like you? We are committed to building a workplace with an inclusive culture. 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 hardship.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$93,900.00 - $153,300.00