Process Development Associate, Synthetic and Bioconjugation Scale-Up Technologies (SBST) (1 of 2)

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Associate for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimization using the principles of Quality by Design (QbD) to make the processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization.

A typical day in the role of Process Development Associate II might include:

• Working at the bench to design and develop scalable, robust and controlled GMP-ready bioconjugation and purification processes.

• Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization techniques.

• Discussing plans and data in cross functional teams to evaluate processes and determine developmental goals and ensure integrated program success.

• Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc.

• Using statistical design of experiments (DOE) to optimize bioconjugation processes including conjugation reactions, purification operations, and analytical characterization.

• Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMO’s intended for GMP production and successfully transferring processes with immediate, first-time success.

• Researching, identifying, and developing new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT) to ensure robust and controllable bioconjugation and purification processes.

• Authoring robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities.

• Analyzing and presenting data in a clear and cohesive manner to a broad audience facilitating data-driven decision making.

• Authoring, reviewing, or providing domain expertise for publications, reports, tech transfer documents, regulatory support documents and patents.

• Being a responsible lab citizen by ensuring timely maintenance of lab equipment, keeping the lab tidy and organized and proactively planning for lab resources.

• Coaching and mentorship of junior team members of the organization as needed.

This Role May be for You if You:

• Enjoy working in the lab to advance exciting new drug modalities to patients.

• Have strong initiative and aim to complete challenging tasks and learn new technologies.

• Have a strong fundamental understanding of various protein purification and technology transfer principles

• Are capable of multi-tasking and working both independently and in a collaborative environment involving cross-functional teams.

• Have excellent interpersonal, verbal and written communication skills.

• Can think critically and demonstrate problem-solving skills.

This role requires a Bachelor’s + 0-3 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, membrane technologies etc. is preferred. Experience with a variety of analytical characterization tools such as electrophoresis, mass spectrometry, high-performance liquid chromatography (HPLC), UV spectroscopy, etc. is preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 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)