Process Scientist

Rensselaer, NY
Oct 23, 2019
Required Education
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: Supports the Manufacturing, CMC Regulatory, and Process Sciences Departments through activities and documentation related to implementation and maintenance of in-process control programs for manufacturing bioprocesses.
Essential Duties and Responsibilities may include, but are not limited to, the following:

• Collates and analyzes data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to develop IPC programs.

• Applies statistical process control tools for limit establishment and monitoring of the manufacturing process.

• Contributes to scientific analysis of results generated from laboratory-scale, and manufacturing-scale studies, including determination of possible mechanisms of process behavior in cell culture and/or purification systems.

• Completes and reviews IPC documentation associated with batch manufacture.

• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.

• Participates in process and quality risk assessments.

• Presents findings, limit setting strategies, and process monitoring data at group, departmental, and interdepartmental meetings as necessary.

• Assists in troubleshooting activities associated with the manufacturing process.

• Supports off-site transfer activities as needed.

Knowledge and Skills:

• Ideal candidate should have knowledge of and/or experience with:
o Process validation
o Cell culture
o Protein chromatography

• Strong interpersonal, oral, and written communication skills

• Knowledge of statistical analysis, word processing, spreadsheet, database management, graphing, and presentation programs

• Knowledge of cGMP operations and large-scale equipment

• Knowledge of IPC strategies and execution of validation support packages is beneficial

Education and Experience:

• Requires PhD in Chemistry, Biology, Biochemistry, Chemical Engineering, or a related field, and a minimum of 1 year in a biopharmaceutical cGMP environment preferred.

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.