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

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

Job summary

Regeneron is seeking a Process Development Engineer II to join the PMPD group in Tarrytown, NY. You will design scalable bioconjugation and purification processes for GMP-ready production, collaborating with cross-functional teams to apply QbD principles and support technology transfer to CDMOs or Regeneron manufacturing suites.

The role emphasizes DOE-driven process optimization, data-driven decision making, and on-site support during scale-up activities.

Qualifications

• Bachelor's or Master's degree with relevant work experience in chemical/biochemical engineering.
• Experience with antibodies in bioconjugates space is highly preferable.
• Hands-on bioconjugation with downstream purification techniques.
• Analytical characterization tools include electrophoresis, mass spectrometry, HPLC, and UV spectroscopy.
• Strong initiative, multitasking, and cross-functional collaboration.

Responsibilities

• Design and develop scalable GMP-ready bioconjugation and purification processes.
• Collaborate with analytical groups to establish characterization techniques.
• Present data to cross-functional teams for program decisions.
• Ensure safety and regulatory compliance (FDA/DoT).
• Apply DOE to optimize processes and transfer to CDMOs or Regeneron sites.
• Lead technology transfer documentation and on-site scale-up support.
• Communicate findings clearly to broad audiences and stakeholders.
• Mentor junior team members as needed.

Skills

Bioconjugation

Process development

DOE

Cross-functional teamwork

Data presentation

Education

Bachelor's degree + 5-6 years in chemical/biochemical engineering

Master's degree + 3-4 years in chemical/biochemical engineering

Tools

Chromatography

Ultrafiltration/Diafiltration

Membrane technologies

Mass spectrometry

HPLC

UV spectroscopy

Electrophoresis

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 preferredli>
• 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

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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