Process Specialist - Manufacturing
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manufacturing Process Specialist (Associate through Senior level) to join our IOPS team, providing technical support across our manufacturing processes and playing a key role in the implementation and transfer of our production programs. In this role, you will resolve process challenges, support manufacturing personnel on the floor, and drive continuous improvement — while collaborating with Process Sciences, Engineering, Maintenance, Quality, Regulatory, and Facilities teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Requirements
- BS in Life Sciences or a related field
- Associate Specialist: 0–2 years of relevant cGMP manufacturing, engineering, or scientific experience
- Specialist: 2+ years of relevant cGMP manufacturing, engineering, or scientific experience
- Senior Specialist: 5+ years of relevant cGMP manufacturing, engineering, or scientific experience
- May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role
- Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
Nice To Haves
- Experience in a cGMP manufacturing environment with familiarity with drug substance or drug product manufacturing processes preferred
Responsibilities
- Liaise with process science and technology transfer teams on the transfer and startup of manufacturing processes; serve as a key technical contributor to manufacturing records, batch sheets, and procedures
- Provide technical input to resolve process problems on and off the production floor; support manufacturing personnel in building technical knowledge of critical process steps
- Write and review SOPs and other controlled documents; modify process method files through the quality system in alignment with change control requirements
- Support CAPA implementation for process-related improvements and contribute to investigations into process variances in accordance with site procedures
- Partner cross-functionally with Maintenance, Process Sciences, Engineering, Facilities, Process Development, Regulatory, Quality Assurance, and Quality Control to resolve process issues and implement improvements
- Support Right First Time (RFT) programs on the floor and implement continuous improvement initiatives across manufacturing operations
- Represent Manufacturing during regulatory and client audits; uphold the highest safety standards and support safety improvements requiring technical input
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
