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

Regeneron Pharmaceuticals•Tarrytown, GA

40d•$93,900 - $153,300•Onsite

About The Position

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.

Requirements

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

Responsibilities

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