VP, CMC Biologics — Strategy, Scale-Up & Partnerships

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

Job summary

Korsana Biosciences, Inc. in Waltham, MA is seeking a VP, CMC to lead the CMC strategy across biologics from discovery through regulatory submission.

This role partners with QA, Regulatory, Clinical, and external CDMOs to deliver high-quality drug substance/product, analytics, and release testing on schedule and within budget. The ideal candidate will have 15+ years in biologics development, at least 5 years as a CMC head, and a proven track record in IND/IMPD/MAA submissions.

Qualifications

• Ph.D. in (bio)chemistry or related field, or MS/BS with equivalent education or experience is required.
• A minimum of 15+ years of experience in biologics development and manufacturing in biotech or biopharma with at least 5 years as CMC head.
• Experience in a fast-paced, high-growth startup environment is preferred.
• Hands-on experience with IND/IMPD/BLA/MAA submissions and approvals.

Responsibilities

• Develop, implement, and execute CMC strategy for biologics technical development including drug substance, drug product, combination product, analytical methods, cGMP manufacturing, and product release and stability testing.
• Lead biologics product development, scale-up, tech transfer and analytical method development, qualification and validation with CDMOs and contract labs.
• Build, maintain and evolve the CMC function to align with the growth of company’s pipeline.
• Lead the selection of CDMOs and contract labs, contract negotiation, and budget/scope management.
• In partnership with QA, support deviation investigations and associated CAPAs implementation.
• Author and review CMC sections, Module 3 Quality, of global regulatory submissions (IND/IMPD/BLA/MAA).
• Ensure product supply for clinical and preclinical studies.
• Establish and maintain an understanding of current trends and emerging biologics development and manufacturing technologies.
• Responsible for establishing and managing objectives/priorities and budgets for the CMC function.
• Develop and maintain SOPs, policies, and guidance documents relevant to areas of responsibility.
• Regularly update executive management with respect to CMC deliverables and timelines

Skills

Leadership

Strategic thinking

Communication

CDMOs management

Education

PhD in (bio)chemistry or related field

MS/BS with equivalent experience

Job description

Korsana Biosciences, Inc. in Waltham, MA is seeking a VP, CMC to lead the CMC strategy across biologics from discovery through regulatory submission.

This role partners with QA, Regulatory, Clinical, and external CDMOs to deliver high-quality drug substance/product, analytics, and release testing on schedule and within budget. The ideal candidate will have 15+ years in biologics development, at least 5 years as a CMC head, and a proven track record in IND/IMPD/MAA submissions.