QA Project Manager (Drug Product)
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY, United States
- Start date
- Apr 26, 2019
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- Discipline
- Marketing, Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Summary: Support manufacturing activities at CMOs and partners by providing quality oversight. Accomplishes quality objectives by planning and evaluating project activities. The PM support may include operations and validation.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Provide operational support to manufacturing operations at CMO sites including formulation, fill/finish, assembly, packaging and labeling activities.
• Primary interface with External Manufacturing Project Managers for all quality related issues at CMOs, including but not limited to qualification activities, process validation, process investigations, and process improvements
• Resolving problems, identifying trends and determining system improvements
• Ensuring compliance with internal procedures and regulatory expectations by proactively working with quality organizations at CMOs.
• Preparing and completing action plans; implementing productivity, quality, and customer-service standards
• Implementing change when necessary within the guidelines of GMP manufacturing operations.
• Support Qualification/Start-up activities at internal/CMO drug product sites
• Interacting with Subject Matter Experts to provide guidance/direction to CMO sites with respect to equipment/process strategic initiatives
Education and Experience:
• Requires BS/BA in a scientific discipline with 10+ years of related experience in a cGMP environment, preferably in a project management capacity for pharmaceutical or biotechnology industries. QA/QC experience preferred.
• Working knowledge of Installation and Operational Qualification Expectations/Requirements, with direct experience on concept preferred.
• Working knowledge of Sterilization qualification Expectations/Requirements, with direct working experience on concept preferred.
*Level will be determined based on skills and related experience.*
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.
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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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