B87 Filling and Formulation Manager Job Lower Merion area,Pennsylvania USA,Manufacturing / Production

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 (5W2

Hs, Gembas, MSV/LSVs, e 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.