B87 Filling and Formulation Manager
Sanofi
September 04, 2026
On-site
Swiftwater, PA
$90,000 - $130,000 USD yearly
Operations
Role Responsibilities:
- Lead startup operations for aseptic filling and formulation in a new facility through commissioning, qualification, and commercial readiness.
- Drive preparation and execution of Development Aseptic Process Simulations (media fills/APS) by Q4 2026.
- Oversee PPQ execution and commercial readiness throughout 2027; ensure inspection readiness by Dec 2027.
- Serve as SME for aseptic operations during C&Q and validation activities.
- Lead Environmental Monitoring Performance Qualifications (EMPQs), smoke studies, and cleanroom qualification.
- Own shift performance for aseptic filling and formulation; drive execution using SMS 2.0 standards.
- Leverage digital systems (eOOE, iObeya, SAP, Qualipso, Ocularis) and lead real-time problem solving.
- Lead operational functions (5W2Hs, Gembas, MSV/LSVs, eBR approvals, Sartocheck, Paltronic, Ops Tracker audits) and support closure of deviations/quality items.
- Build and develop a high-performing operations team; foster continuous improvement and cross-functional collaboration.
- Champion digital transformation and Industry 4.0 adoption in aseptic operations.
Qualifications (Required):
- Bachelor’s in Life Sciences/Engineering (or related) + 1+ year GMP/pharma manufacturing operations + 6+ months people leadership OR High School Diploma + 5+ years GMP/pharma operations + 1+ years people leadership.
- Demonstrated aseptic processing experience (Drug Substance, Drug Product, Biologics).
- Strong GMP and regulatory compliance knowledge.
- Proven leadership; excellent communication and technical writing.
- Ability to work flexible hours (extended shifts/weekends) as needed.
- Proficiency with digital systems and data analytics tools.
Qualifications (Preferred):
- Facility/production line startup, commissioning, or qualification experience; APS/PPQ media fill background.
- Lean/Six Sigma or continuous improvement experience; Lean operating systems.
- Industry 4.0 concepts/digital manufacturing tools; change management in regulated environments.
- Experience in biologics/vaccines/sterile drug product manufacturing.
Schedule:
- 2nd shift leadership role; flexible during startup/qualification; C&Q primarily first shift; media fills/PPQs/commercial launch require shift-aligned hours.
- Lead startup operations for aseptic filling and formulation in a new facility through commissioning, qualification, and commercial readiness.
- Drive preparation and execution of Development Aseptic Process Simulations (media fills/APS) by Q4 2026.
- Oversee PPQ execution and commercial readiness throughout 2027; ensure inspection readiness by Dec 2027.
- Serve as SME for aseptic operations during C&Q and validation activities.
- Lead Environmental Monitoring Performance Qualifications (EMPQs), smoke studies, and cleanroom qualification.
- Own shift performance for aseptic filling and formulation; drive execution using SMS 2.0 standards.
- Leverage digital systems (eOOE, iObeya, SAP, Qualipso, Ocularis) and lead real-time problem solving.
- Lead operational functions (5W2Hs, Gembas, MSV/LSVs, eBR approvals, Sartocheck, Paltronic, Ops Tracker audits) and support closure of deviations/quality items.
- Build and develop a high-performing operations team; foster continuous improvement and cross-functional collaboration.
- Champion digital transformation and Industry 4.0 adoption in aseptic operations.
Qualifications (Required):
- Bachelor’s in Life Sciences/Engineering (or related) + 1+ year GMP/pharma manufacturing operations + 6+ months people leadership OR High School Diploma + 5+ years GMP/pharma operations + 1+ years people leadership.
- Demonstrated aseptic processing experience (Drug Substance, Drug Product, Biologics).
- Strong GMP and regulatory compliance knowledge.
- Proven leadership; excellent communication and technical writing.
- Ability to work flexible hours (extended shifts/weekends) as needed.
- Proficiency with digital systems and data analytics tools.
Qualifications (Preferred):
- Facility/production line startup, commissioning, or qualification experience; APS/PPQ media fill background.
- Lean/Six Sigma or continuous improvement experience; Lean operating systems.
- Industry 4.0 concepts/digital manufacturing tools; change management in regulated environments.
- Experience in biologics/vaccines/sterile drug product manufacturing.
Schedule:
- 2nd shift leadership role; flexible during startup/qualification; C&Q primarily first shift; media fills/PPQs/commercial launch require shift-aligned hours.