Role Summary
Drug Production, Associate Manufacturing Specialist. Regeneron is seeking a Drug Production, Associate Manufacturing Specialist in Global Manufacturing to manufacture life-changing medicines in a clean room environment.
Responsibilities
- Perform all aspects of drug production in a clean room including cell culture and purification of monoclonal antibodies
- Complete and review batch records and logbooks in accordance with cGMP and SOP
- Perform in-process sampling and analysis of buffer solutions, cell culture, and drug substance
- Operate automated equipment such as bioreactors, chromatography columns, and filtration skids
- Support equipment start-up, troubleshooting, and validation
- Partner with R&D teams to implement new drug manufacturing processes and technologies
Qualifications
- HS diploma + 4 years of relevant work experience or
- AS, BS or BA in Life Sciences or related field
Skills
- Ability to operate in a fast-paced, highly regulated environment
- Strong organizational, detail-oriented, and communication skills
- Proficiency with computerized systems for daily tasks
- Ability to work in both small and large teams and adapt to changing priorities
Education
- AS, BS or BA in Life Sciences or related field
Additional Requirements
- Shift flexibility with 4 x 10-hour shifts to support 24/7 production
- Physical ability to perform job duties in a clean room environment (up to 10 hours per shift) and lift/push/pull up to 50 lbs
- Gowning in full cleanroom attire and compliance with cleanroom procedures