Role Summary
Regeneron is currently looking for a Drug Production, Associate Manufacturing Specialist in the Global Manufacturing department. In this role, you will focus on manufacturing life changing medicines for patients around the world while working in a clean room environment.
Responsibilities
- Performing all aspects of drug production in a clean room including cell culture and purification of monoclonal antibodies
- Completing and reviewing batch records and logbooks in accordance with Current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP)
- Performing in-process sampling and analysis of buffer solutions, cell culture, and drug substance
- Operating automated equipment such as bioreactors, chromatography columns, and filtration skids
- Supporting equipment start-up, troubleshooting, and validation
- Partnering with R&D teams to implement new drug manufacturing processes and technologies
Qualifications
- Required: HS diploma + 4 years of relevant work experience
- Required: AS, BS or BA in Life Sciences or related field
Skills
- Ability to operate in a highly regulated environment and strive to continuously improve processes while maintaining compliance
- Ability to learn and use computerized systems for daily performance of tasks
- Good communication skills and the ability to give and receive feedback constructively
Education
- AS, BS or BA in Life Sciences or related field
Additional Requirements
- Gowning and Environment: Full cleanroom attire and procedures; ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire
- Shift & Physical Requirements: Ability to perform physical requirements for up to 10 hours in a clean room; multiple shifts available to support 24/7 production; physical activities may include bending, climbing, crawling, kneeling, reaching, sitting, standing, driving, and lifting/pushing/pulling up to 50 lbs