Manager, Quality Control
$124k - $161kScorpion Therapeutics
Manager, Quality Control (QC) Responsibilities: Independently lead and oversee QC activities at external contract laboratories for inhalation and small molecule drug substance/drug products, including raw materials, in-process, release, and stability testing. Manage analytical projects; review analytical data packages, protocols, test results, and reports for completeness, accuracy, and compliance. Lead deviations, OOS/OOT investigations, and change controls; perform root cause analysis and implement CAPAs. Support and troubleshoot analytical method implementation related to APSD, MMAD, delivered dose, and particle size distribution testing. Ensure timely review/approval of CoAs, method validation/transfer protocols, and analytical methods to enable batch disposition. Lead development/review of product specifications and justification documents. Author/review QC sections of regulatory submissions (INDs, NDAs) and respond to regulatory inquiries. Monitor contract lab performance metrics and drive continuous improvement. Required Qualifications: Bachelor’s degree in Chemistry, Biochemistry, or related field. 4 years of Quality Control experience in biotech/pharmaceutical industry. Analytical testing experience with small molecule or inhalation drug products. Nice to have: MS; combination product familiarity. Strong cGMP/ICH and USP/EP/JP standards knowledge. Oversight of contract testing labs; review of CoAs/protocols/regulatory submissions. Investigation/CAPA experience; communication, collaboration, time management. Where/Travel: Bridgewater, NJ office; full-time in-person. Occasional domestic travel (~10%). Pay Range: $124,000–$161,000 annual. #J-18808-Ljbffr
Vacancy posted 1 day ago
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