Process Development Associate II - Bioreactor Scale-Up and Development

Location
Tarrytown, NY, United States
Posted
Jul 01, 2019
Ref
16829BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary
We are seeking a Process Development Associate II to work in the Bioreactor Scale-Up and Development group within Pre-Clinical Manufacturing and Process Development. This person will be primarily involved in developing clinically-enabling bioreactor processes intended for use in cGMP manufacturing.

Responsibilities

• Cultivation of mammalian cells using aseptic technique in bench and pilot scale bioreactors for the production of monoclonal antibodies.

• Scale-up process evaluation and troubleshooting in support of clinical productions.

• Detailed data analysis of seed train, production, and quality data in support of process understanding and technology transfer followed by authoring of development reports and process transmittals and documentation in electronic notebooks

• Active involvement in Technology Transfer Start-Up Teams, which includes technology transfer via written process transmittals and on-site support to our manufacturing facility in Albany, NY during clinical production campaigns.

• Supports technology development and improvement initiatives. Identifies value adding opportunities for improvement and proposes potential solutions.

• Production of various nonclinical reagents in support of Regeneron's Research and Development activities.

• Executes experiments/projects and analyzes data alone or in collaboration with others

• Links scientific literature and technical documentation to ongoing development

• Technical writing and presentations to senior management are lucid and succinct with clear line of sight between hypothesis and conclusion

• Responsible for maintaining scientifically current (state of the art) laboratory environment and/or product inventory. Maintains accurate and complete records consistent with company policy and legal requirements.

• Has cross-functional knowledge and skills, contributes within his/her own functional area.

Other Duties and Responsibilities:

• Contributes to lab equipment maintenance and safety to help create a safe, effective and efficient working environment.

• Anticipates and recognizes potential problems with laboratory supplies / equipment and acts to prevent and solve problems.

• Keep up with SOP training and/or compliance responsibilities.
Requirements
This position requires a Bachelor's Degree or Master's Degree in Engineering with 0-2yrs experience. Candidates with experience with the below preferred:

Bioreactor Scale-Up and Development
NOVA FLEX, Sartorius Biostat DCU Bench top Bioreactors, Applikon bench top bioreactors, WAVE bioreactors, ABEC/Hyclone Single Use Bioreactors (50-500L), ABEC Stainless Steel Pilot Scale (40-500L) bioreactors, Medium Prep skid, CIP, Biosafety cabinets, incubators, autoclave, Computational Fluid Dynamics, ANSYS Fluent, PI Historian, JMP, LIMS, Kepware.

Please include your GPA on your resume in order to be considered!

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.