Staff Engineer, Fermentation Development

Regeneron Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a Staff Engineer for Plasmid Purification Process Development . In this role, you will work as part of a multi-functional team to develop Fermentation manufacturing processes, fermentation derived-starting materials, and products with the aim of providing treatment to unmet medical needs.

Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.

A Typical Day in the Role Might Look Like :

• Leading the design, execution / optimization, scale-up and characterization of robust processes for purifying fermentation products (e.g., plasmid DNA and recombinant proteins) and starting materials from microbial expression platforms.
• Independently utilizing multivariate design of experiment approaches such as DOE with influences from experimental data and scientific literature to solve molecule specific-problems and optimize parameters for purification of fermentation starting materials and products.
• Designing and executing in-process methods to quantify process derived impurities and product quality attributes across multiple assay formats.
• Discussing development program risks, and / or experimental data in multi-functional teams to evaluate process performance, determine / adjust development plans, and ensure integrated program timeline success.
• Documenting and presenting experimental execution and results. Maintaining and troubleshooting equipment.
• Partnering with External Manufacturing group and other related functions at Regeneron’s Industrial Operations and Product Supply (IOPS) organization to provide technical assessment of CDMO’s GMP production capability (gap assessments) and provide technology transfer support to ensure first-time-right time performance.
• Driving fermentation-purification platform development and new technology implementation to improve process performance, generation of predictive process models, and enhance process control and robustness.
• Cross-training on and providing support to formulation, analytical and upstream operations.
• Support weekend or off-hour experimental and pilot scale work, as required.

This Role Might Be For You If You :

This position requires a Bachelor’s degree in either Chemical Engineering, Biochemical Engineering, Biochemistry, or related field with 8-10 years, a Master’s Degree with 8-10 years, or a Ph.D with 3-5 years of meaningful experience. The extent of the candidate’s prior experience will determine the grade of the position. A strong fundamental understanding of the principles of purification process development, a history of developing downstream steps within bioprocesses, and process scale up is required. Experience preferred with the following systems : Depth filtration, Tangential flow filtration, Cell lysis, Centrifugation (e.g., continuous, disc stack), Ultrafiltration / Diafiltration, and Chromatography utilizing the Akta Avant 150 / Pilot (e.g., ion exchange, hydrophobic interaction, and size exclusion). Proficiency with statistical analysis software (e.g., DOE, and Spotfire) is also required. Prior experience with purifying plasmid DNA is desired, and consideration will be given to similar experience with other biologics such as monoclonal antibodies, bispecific antibodies, adeno-associated virus, and other therapeutics proteins.

Salary Range (annually) : $106,200.00 - $173,200.00

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Salary : $106,200 - $173,200