Aseptic Fill & Formulation Manager

Scorpion Therapeutics

Pennsylvania

On-site

USD 150,000 - 210,000

Full time

6 days ago

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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.