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

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

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Process Development Engineer II for the PMPD group in Tarrytown, NY. You will develop conjugation and purification processes for bioconjugation of proteins to synthetic molecules, applying QbD principles for GMP readiness, and support tech transfer to CDMOs or Regeneron manufacturing sites.

The role requires designing scalable processes, collaborating across teams, and mentoring junior staff, with onsite, full-time employment in a fast-growing

Qualifications

• Bachelor's degree or higher with 5–6 years for bachelor-track or 3–4 years for master-track in chemical/biochemical engineering or related field.
• Experience with antibodies in the bioconjugates space is highly preferable.
• Hands-on experience with bioconjugation processes (lysine-based, cysteine-based, site-specific) with downstream purification techniques.
• Experience with analytical characterization tools such as electrophoresis, mass spectrometry, HPLC, UV spectroscopy.

Responsibilities

• Design and develop scalable GMP-ready bioconjugation and purification processes.
• Collaborate with analytical groups to establish characterization techniques.
• Lead technology transfer and documentation for CDMO partnerships.
• Use DOE to optimize bioconjugation processes and analytical methods.
• Present data clearly to cross-functional teams and stakeholders.
• Mentor junior team members and ensure lab safety and compliance.

Skills

GMP bioconjugation

Bioconjugation techniques

DOE

Scale-up

Data analysis

Cross-functional collaboration

Mentoring

Analytical characterization

Education

Bachelor's degree in chemical/biochemical engineering or related field

Master's degree in chemical/biochemical engineering or related field

Tools

CDMOs

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.

#pmpd

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

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
• 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 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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.