Hybrid Senior QC Lead – GMP Methods & Stability

Stoke Therapeutics; Bedford (MA); Hybrid; USD 172,000 - 192,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics in Bedford, MA, is seeking a Sr. Manager, QC to oversee GMP testing and stability programs across CTLs/CMOs, ensuring compliance and product quality for clinical-stage ASO medicines.

You will lead analytical method transfers, validation, and regulatory-ready documentation, partner with CMC teams, support inspections, and drive continuous improvement in QC laboratory controls while working in a hybrid Bedford-based setup.

Qualifications

• BS degree in Biochemistry, Chemistry, Biology, or Pharm and 8+ years' biopharma experience incl. analytical method development and transfer.
• GMP, ICH, FDA knowledge; work with CTLs/CMOs for release testing.
• Hands-on QC oversight of GMP labs; attention to detail in cross-functional teams.

Responsibilities

• Establish and maintain QC SOPs for GMP testing and stability management.
• Oversee outsourced GMP release testing at CTLs/CMOs.
• Evaluate sample size for functional testing of devices for release and stability.
• Provide QC support for method transfers and validation.
• Review analytical docs, CoAs, and specifications.
• Contribute to regulatory submissions’ analytical sections.

Skills

GMP compliance

Analytical methods

QC oversight

Regulatory inspections

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in Biochemistry, Chemistry, Biology, Pharmaceuticals or equivalent

Advanced Degree (MS/PhD) preferred

Job description

Stoke Therapeutics in Bedford, MA, is seeking a Sr. Manager, QC to oversee GMP testing and stability programs across CTLs/CMOs, ensuring compliance and product quality for clinical-stage ASO medicines.

You will lead analytical method transfers, validation, and regulatory-ready documentation, partner with CMC teams, support inspections, and drive continuous improvement in QC laboratory controls while working in a hybrid Bedford-based setup.