Note: The job is a remote job and is open to candidates in USA. Regeneron is a biopharmaceutical company seeking a Principal Manufacturing Sciences & Technology Engineer for its Process Sciences Drug Product Engineering department. The role leads and supports drug product manufacturing process transfers, equipment selection and qualification, process validation, cGMP start-up, troubleshooting, compliance, investigations, and operational improvement while partnering with internal teams and contract manufacturers.
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
- Bring demonstrated technical knowledge in drug product manufacturing, product development, and validation, along with experience interacting with Contract Manufacturing Organizations
- Apply strong knowledge of industry practices and regulations (cGMP, Annex I) across multiple health authorities, including FDA, EMA, and MHRA
Skills
- Principal MSAT Engineer: 8+ years of relevant experience
- Staff MSAT Engineer: 10+ years of relevant experience
- Travel percentage: 25-50% domestic & occasionally international
- Apply strong knowledge of industry practices and regulations (cGMP, Annex I) across multiple health authorities, including FDA, EMA, and MHRA
- Bring demonstrated technical knowledge in drug product manufacturing, product development, and validation, along with experience interacting with Contract Manufacturing Organizations
- BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred
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
Company Overview
Company H1B Sponsorship