Manager, Quality Control

Scorpion Therapeutics; Bridgewater (MA); On-site; USD 124,000 - 161,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager, Quality Control (QC) to lead QC activities at external contract laboratories for inhalation and small molecule drug substances and products.

You will oversee analytical projects, participate in investigations, and ensure regulatory readiness.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or related field is required.
• Minimum 4 years of QC experience in biotech/pharmaceutical industry.
• Analytical testing experience with small molecules or inhalation drug products.

Responsibilities

• Independently lead and oversee QC activities at external contract laboratories for inhalation and small molecule drug substances/products.
• Manage analytical projects; review 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 corrective actions.
• 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 for 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.

Skills

Leadership

Project management

Regulatory submissions

Investigation/CAPA

Contract lab oversight

Analytical testing

Education

Bachelor’s degree in Chemistry, Biochemistry, or related field

MS; combination product familiarity

Job description

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.