Manager, Quality Control
Insmed Incorporated
August 20, 2026
On-site
Bridgewater, NJ
Operations
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.
Application Instructions:
- Current Insmed employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from posting date or until filled.
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.
Application Instructions:
- Current Insmed employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from posting date or until filled.