VP Biologics CMC Strategy & Manufacturing

Korsana Biosciences; Waltham (MA); On-site; USD 300,000 - 340,000; Full time

Benefits offered by this job

Equity-based compensation

Bonus potential

Job summary

Korsana Biosciences is seeking a Vice President of CMC to lead the development and execution of CMC strategy across biologics programs. The role oversees outsourced CMC activities, including manufacturing, release, stability testing, and collaboration with CDMOs to ensure timely, high-quality deliverables.

The position requires a Ph.D. or equivalent, with 15+ years in biologics and at least 5 years as CMC head, plus hands-on experience with IND/IMPD/BLA/MAA submissions in a fast-paced biotech

Qualifications

• Ph.D. in (bio)chemistry, (bio)chemical engineering or related field is required.
• At least 15+ years in biologics development and manufacturing with 5+ years as CMC head.
• Experience in a fast-paced startup environment preferred.
• Hands-on experience with IND/IMPD/BLA/MAA submissions and approvals.

Responsibilities

• Develop, implement, and execute CMC strategy for biologics including drug substance, drug product, and analytical methods.
• Lead CDMO and contract lab oversight, tech transfer, and method development/validation.
• Manage budgets, scope, and strategic priorities for the CMC function.
• Collaborate with QA on deviations and CAPAs and support regulatory submissions (Module 3).
• Ensure product supply for clinical and preclinical studies and stay current with biologics development and manufacturing trends.

Education

Ph.D. in (bio)chemistry, (bio)chemical engineering) or related field

MS/BS with equivalent education or experience

Tools

CDMOs management

Job description

Korsana Biosciences is seeking a Vice President of CMC to lead the development and execution of CMC strategy across biologics programs. The role oversees outsourced CMC activities, including manufacturing, release, stability testing, and collaboration with CDMOs to ensure timely, high-quality deliverables.

The position requires a Ph.D. or equivalent, with 15+ years in biologics and at least 5 years as CMC head, plus hands-on experience with IND/IMPD/BLA/MAA submissions in a fast-paced biotech