Regeneron Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a Process Development Engineer III 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.
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: Enjoy working in the lab to advance exciting new drug modalities to patients.Have a strong fundamental understanding of plasmid DNA and protein purification, process scale-up, and technology transfer principles.Enjoy developing talent in junior team members.You have strong initiative to complete challenging tasks and lead the evaluation of new process technologies.You are capable of multi-tasking, thinking critically, working both independently, as part of a team, and as a team-leader.Have excellent interpersonal, verbal, and written communication skills.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 5-7 years, or a Ph.D with 0-2 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.
#pmpd Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
Salary Range (annually) $106,200.00 - $173,200.00
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