B87 Filling and Formulation Manager

Scorpion Therapeutics; Pennsylvania; On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Pennsylvania seeks a seasoned leader to drive startup operations for aseptic filling and formulation in a new facility, guiding commissioning, qualification, and commercial readiness. You will oversee media fills, APS, PPQ, and inspection readiness as the site scales toward launch.

You will serve as SME for aseptic operations during C&Q and validation, lead EMPQs and cleanroom qualification, and own shift performance.

Qualifications

• 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.

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.

Skills

People leadership

Regulatory compliance

Communication

Technical writing

Digital systems

Data analytics

GMP knowledge

Education

Bachelor's in Life Sciences/Engineering or related

High School Diploma with 5+ years GMP operations

Tools

SAP

Qualipso

Ocularis

Job description

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.