We are seeking a Process Development Engineer I to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group as a part of our Preclinical Manufacturing & Process Development (PMPD) department. In this exciting new role, you will develop manufacturing processes for the production of synthetic small-molecules used in Regeneron’s diverse range of therapeutic modalities. You would work in close collaboration with cross-functional teams performing chemical process development and optimization using the principles of Quality by Design (QbD) to deliver 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) to ensure timely and reliable entrance to the clinic and eventual commercialization.
A typical day in the role of a Process Development Engineer I might include:
- Working at the bench to design and develop scalable, robust and controlled GMP-ready processes for synthetic small molecules.
- Collaborating with analytical groups within or outside the organization to establish supportive analytical characterization of synthetic intermediates and final products.
- Discussing plans and data in multi-functional teams to evaluate processes and determine developmental goals and ensure integrated program success.
- Proactively complying with 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 synthetic chemical processes including reaction parameters, purification operations, and analytical characterization.
- Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to provide technical assessment of CDMOs 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 synthetic 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 >Salary Range (annually)
