Principal Manufacturing Sciences & Technology Engineer
About The Position
Regeneron is seeking a Principal MSAT Engineer to join our Process Sciences Drug Product Engineering department. This role supports and/or leads equipment selection, CMO selection strategy, management of equipment qualification and/or process validation activities and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of internal or external manufacturing, reviews process data to ensure operational consistency after processes are successfully transferred and provides support for investigations.
Requirements
- Demonstrated technical knowledge in drug product manufacturing, product development, and validation, along with experience interacting with Contract Manufacturing Organizations
- Strong knowledge of industry practices and regulations (cGMP, Annex I) across multiple health authorities, including FDA, EMA, and MHRA
- BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred
- Principal MSAT Engineer: 8+ years of relevant experience
- Staff MSAT Engineer: 10+ years of relevant experience
- Level is determined based on qualifications relevant to the role
Responsibilities
- Serves as technical lead and subject matter expert for drug product manufacturing process transfer, providing oversight for new product introduction, technology transfer, and process troubleshooting/issue resolution
- Tracks and reports project milestones (raw material/component procurement, equipment readiness, analytical transfer, documentation) and partners with/leads cross-functional internal and external teams to ensure successful transfer execution
- Reviews and approves cGMP batch documentation (master batch records, specifications, validation protocols) and authors policies, technical reports, protocols, and change controls in support of cGMP activities
- Monitors cGMP compliance at drug product contract manufacturers to protect product integrity and company reputation
- Trends process performance to establish and improve process capability, ensuring operations remain within the intended control strategy
- Investigates deviations, determines root cause, and identifies/implements CAPA; develops sampling plans for GMP batches (lot release, stability, characterization)
- Collaborates with internal/external teams to identify and drive opportunities for improved process performance and cGMP operations
- Leads or assists in equipment selection, qualification, and start-up activities, and works with Manufacturing to ensure robust operating procedures
- Partners with Strategic Sourcing/Procurement to define technical requirements for raw materials, components, equipment, and services, ensuring on-time vendor delivery
- Works with DP MSAT management to define organizational structure, prioritize strategic initiatives, and assess staffing needs to support growth
- Leverages subject matter expertise to resolve emerging issues and escalates to line management as needed to manage impact
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
Principal
