Process Scientist
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY
- Start date
- Oct 23, 2019
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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