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.

$70,300.00 - $110,100.00