Regeneron Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a Process Development Engineer III for fermentation 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 Include:
- 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 applying multivariate design of experiment approaches such as DOE with influences from experimental data and scientific literature to tackle molecule specific-problems and optimize parameters for purification of fermentation starting materials and products.
- Crafting and performing 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 coordinated program timeline success.
- Detailing and presenting experimental execution and results. Maintaining 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 improve process control and adaptability
This Role Might be For You If You:
- Enjoy working in the lab to advance exciting new drug modalities to patients.
- You have strong initiative to complete daring tasks and be responsible for the evaluation of new process technologies.
- 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 0-3 plus years of shown experience. A strong fundamental understanding of the principles of downstream development, a history of developing downstream steps within bioprocesses, and process scale up is helpful. Experience preferred with the following systems: Depth filtration, Tangential flow filtration, Cell lysis, Centrifugation (e.g., continuous, disc stack), Ultrafiltration/Diafiltration, and Chromatography using 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.
Intro To PMPD Video:
Intro To Viral Production Core:
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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)