Manager, Quality Control

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.

• 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.

• 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.

• Bridgewater, NJ office; full-time in-person.
• Occasional domestic travel (~10%).

• $124,000–$161,000 annual.