Sr. Manager Quality Control - Chemistry
Scorpion Therapeutics
Responsibilities Lead QC Chemistry laboratory and 1st/2nd shift Quality Control operations; oversee startup, operational readiness, and transition to steady-state commercial operations. Manage day-to-day QC Chemistry operations and 1st/2nd shift QC teams (7 days/week cross‑functional night shift support). Lead analytical method transfer, qualification/validation, and routine testing. Support analytical method families: chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel‑based methods, and compendial chemistry testing. Ensure compliance with safety guidelines, cGLPs, cGMPs, and applicable regulations. Build, coach, and develop a high‑performing QC organization; implement effective digital tools. Partner cross‑functionally with Manufacturing, Process Development, QA, Facilities & Engineering, Supply Chain, and others. Support regulatory inspections and site licensure/inspection readiness. Drive Lean principles, establish goals/KPIs/staffing models for sustainable 24/7 operations, translate technical data to actionable insights, and lead operational excellence. Basic Qualifications High school/GED + 12 years Aseptic Manufacturing OR Associate’s + 10 years OR Bachelor’s + 8 years OR Master’s + 6 years OR Doctorate + 2 years. Minimum 2 years directly managing people and/or leading teams/projects/resources. Preferred Qualifications GMP/pharma environment experience (classified areas/gowning); chemistry‑related degree. QC analytical chemistry operations (method transfer/qualification/validation/routine testing for biologics). Experience with deviations, CAPAs, change controls, regulatory documentation, data integrity, inspections. Strong communication; independent leadership; Lean/continuous improvement. Benefits (Total Rewards) Health/welfare, retirement/savings, bonus (or sales incentive), stock incentives, time‑off, flexible work models where possible. Application Instructions Apply via careers.amgen.com. No application deadline; sponsorship not guaranteed. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 2 days ago
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