Drug Production, Associate Manufacturing Specialist

About the role

Regeneron is currently seeking a Biotech Production Specialist to join their Global Manufacturing team. This role focuses on manufacturing life-changing medicines in a clean room environment.

Responsibilities

• Cover all facets 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 SOPs
• 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
• Work in a fast-paced setting where priorities can quickly change based on business needs and patient needs
• Operate in a highly regulated environment, striving to continuously improve processes and maintain compliance to manufacture safe and effective medicines for patients
• Use computerized systems for daily performance of tasks

Physical Requirements

• Gowning: Full cleanroom attire including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents during gowning process
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire
• Perform physical requirements for the entirety of the shift (up to 10 hours) in a clean room environment
• Physical requirements may include: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation, and ability to lift/push/pull up to 50 lbs