Process Scientist

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 Process Sciences Department IPC Development group through laboratory-scale validation and evaluation studies, as well as the design, implementation and maintenance of in-process control (IPC) programs for manufacturing bioprocesses.

Essential Duties and Responsibilities may include, but are not limited to, the following:

• Develops and writes protocols for laboratory-scale process validation and evaluation studies.

• Conducts scaled-down mammalian cell culture and/or antibody purification production procedures to support characterization and validation of candidate or existing bioprocesses.

• Collects and analyzes results and writes summary reports of laboratory-scale process validation and evaluation studies.

• Collates and analyzes data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to develop in-process control programs for manufacturing bioprocesses.

• Oversees lifecycle activities of established in-process control programs for manufacturing bioprocesses, including impact assessment, change control, and document generation or revision.

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

• Develops and writes responses for technical sections of regulatory documents.

• Presents findings at group and interdepartmental meetings.

• Maintains lab supplies and equipment.

• Produces and maintains accurate records.

Knowledge Skills and Abilities:

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Effective time management skills

• Strong interpersonal skills

• Excellent written and verbal communication skills

Education and Experience:

• Requires PhD in Chemistry, Biochemistry, Chemical Engineering or a related field with 0-2 years experience; may consider another discipline with added relevant experience. cGMP experience is desirable.

• Strong working knowledge of protein biochemistry is required.

• Previous chromatography experience is required.

• Previous filtration experience is desirable.

• Working knowledge of statistics is desirable.

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.