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

Position: Process Development Associate, Synthetic and Bioconjugation Scale-Up Technologies (SBST) (1 of 2)
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Process Development Associate to join our Preclinical Manufacturing & Process Development (PMPD) group's new Synthetic and Bioconjugation Scale-up Technologies (SBST) group, on-site in Tarrytown, NY. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small molecules, working in close collaboration with cross-functional teams to optimize processes using Quality by Design (QbD) principles for GMP production.

This position offers the opportunity to contribute to 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 entrance to the clinic through product commercialization.

When & where:

* Shift Requirements:
Full-time, standard business hours, with on-site presence during scale-up/GMP manufacturing activities as needed

* Location:

On-site in Tarrytown, NY

* Flexibility & travel:
Minimal to no travel; on-site presence required to support lab operations, with occasional travel to CDMO sites for technology transfer

What you'll do:

* Work at the bench to design and develop scalable, robust, and controlled GMP-ready bioconjugation and purification processes

* Collaborate with analytical groups within or outside the organization to establish supportive analytical characterization techniques

* Discuss plans and data in cross-functional teams to evaluate processes and determine developmental goals, ensuring integrated program success

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

* Partner with the External Manufacturing group and other key partners at Regeneron's IOPS organization to provide technical assessment of CDMOs intended for GMP production and successfully transfer processes with immediate, first-time success

* Research, identify, and develop new technologies to improve processes, generate predictive process models, and pioneer novel at-line/in-line process analytical technologies (PAT)

* Author robust technology transfer documentation and support production with onsite presence during scale-up/GMP manufacturing activities

* Analyze and present data in a clear and cohesive manner to a broad audience, facilitating data-driven decision-making

* Author, review, or provide domain expertise for publications, reports, tech transfer documents, regulatory support documents, and patents

* Coach and mentor junior team members of the organization as needed

The environment and physical rhythms of this role:

* This is a hands-on, on-site laboratory role requiring bench work to design and develop bioconjugation and purification processes, along with proactive compliance with lab safety and environmental safety expectations set by Regeneron and regulatory bodies such as the FDA and DoT.

* Flexibility to multitask and work both independently and within cross-functional teams, along with occasional onsite presence during scale-up/GMP manufacturing activities, is required.

Let's find out if we're a fit:

Must-haves:

* Bachelor's degree and 0-3 years of relevant experience in chemical/biochemical engineering or a related field

* Strong initiative and drive to complete challenging tasks and learn new technologies

* Strong fundamental understanding of various protein purification and technology transfer principles

* Excellent interpersonal, verbal, and written communication skills, with the ability to think critically and demonstrate problem-solving skills

Preferred / nice-to-haves:

* Experience with antibodies in the bioconjugates space

* 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

* Experience with analytical characterization tools such as…