Staff External Manufacturing Specialist (Clinical Drug Product)
Regeneron
10 days ago
On-site
East Greenbush, NY
Operations
Responsibilities:
- Act as technical and operational authority for clinical contract drug product (DP) filling at CMO/business partner sites; own end-to-end tech transfer and lead active batch management through lot disposition.
- Provide aseptic filling expertise: sterile filtration, filling (time-pressure, peristaltic, rotary piston), stoppering/capping, and lyophilization cycle development and scale-up.
- Interpret EM, airborne particulate, and media fill (APS) results to assess batch disposition and process adequacy.
- Assess cleanroom design/equipment suitability for Grade A/ISO 5 filling zones and Grade B/C support areas.
- Support E&L risk assessments for product-contact materials and container closure selection.
- Own/lead tech transfer to CMO filling sites: gap assessments, risk evaluations, facility/equipment readiness, and engineering run execution; approve TRD, MBR, validation and summary reports.
- Oversee tech transfer/qualification/validation of filling lines and critical equipment (isolator/RABS, vial/syringe filling, lyophilizers, component prep).
- Provide technical mentorship and leadership for mid-level EM specialists; coach on batch record review, deviation management, and escalation.
- Serve as primary technical contact for active clinical batches; track in-process data, lead deviation investigations and CAPA closure, analyze cycle time/yield/reject trends, and drive continuous improvement.
- Serve as key GMP decision-maker; apply FDA 21 CFR, EU GMP Annex 1, and USP/EP/JP requirements; coordinate post-approval change strategies and support GMP audits.
Qualifications/Required skills:
- Bachelor’s (or advanced) degree in relevant field and 10+ years DP manufacturing with significant sterile filling and CMO oversight.
- Hands-on GMP sterile filling experience (aseptic filling, lyophilization, CCI, inspection).
- Demonstrated tech transfer leadership incl. MBR/TRD, PPQ, and process validation.
- Experience leading deviation investigations and CAPA for sterile filling.
- Ability to mentor technical staff and lead in a team/lead capacity.
- Strong analytical, communication, and cross-functional collaboration skills; ability to decide in ambiguous situations.
- Travel domestically/internationally up to 25%+.
Benefits (if applicable):
- Comprehensive benefits vary by location (U.S. may include medical/dental/vision/life/disability, fitness centers, 401(k) match, equity awards, annual bonuses, paid time off, paid leaves).
Application instructions:
- “Apply now to take your first step…”
- Act as technical and operational authority for clinical contract drug product (DP) filling at CMO/business partner sites; own end-to-end tech transfer and lead active batch management through lot disposition.
- Provide aseptic filling expertise: sterile filtration, filling (time-pressure, peristaltic, rotary piston), stoppering/capping, and lyophilization cycle development and scale-up.
- Interpret EM, airborne particulate, and media fill (APS) results to assess batch disposition and process adequacy.
- Assess cleanroom design/equipment suitability for Grade A/ISO 5 filling zones and Grade B/C support areas.
- Support E&L risk assessments for product-contact materials and container closure selection.
- Own/lead tech transfer to CMO filling sites: gap assessments, risk evaluations, facility/equipment readiness, and engineering run execution; approve TRD, MBR, validation and summary reports.
- Oversee tech transfer/qualification/validation of filling lines and critical equipment (isolator/RABS, vial/syringe filling, lyophilizers, component prep).
- Provide technical mentorship and leadership for mid-level EM specialists; coach on batch record review, deviation management, and escalation.
- Serve as primary technical contact for active clinical batches; track in-process data, lead deviation investigations and CAPA closure, analyze cycle time/yield/reject trends, and drive continuous improvement.
- Serve as key GMP decision-maker; apply FDA 21 CFR, EU GMP Annex 1, and USP/EP/JP requirements; coordinate post-approval change strategies and support GMP audits.
Qualifications/Required skills:
- Bachelor’s (or advanced) degree in relevant field and 10+ years DP manufacturing with significant sterile filling and CMO oversight.
- Hands-on GMP sterile filling experience (aseptic filling, lyophilization, CCI, inspection).
- Demonstrated tech transfer leadership incl. MBR/TRD, PPQ, and process validation.
- Experience leading deviation investigations and CAPA for sterile filling.
- Ability to mentor technical staff and lead in a team/lead capacity.
- Strong analytical, communication, and cross-functional collaboration skills; ability to decide in ambiguous situations.
- Travel domestically/internationally up to 25%+.
Benefits (if applicable):
- Comprehensive benefits vary by location (U.S. may include medical/dental/vision/life/disability, fitness centers, 401(k) match, equity awards, annual bonuses, paid time off, paid leaves).
Application instructions:
- “Apply now to take your first step…”