Biologics CMC/Quality Program Lead

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 153,000 - 180,000; Full time

Job summary

A leading biotech firm in Princeton, NJ seeks an Associate Director for CMC/Quality Project Management. The ideal candidate will have extensive experience in CMC development and regulatory processes, overseeing biologics from early phases to BLA submission. Strong leadership skills and proficiency in project management tools required. This role offers a competitive salary and the opportunity to drive impactful programs in the company.

Qualifications

• Minimum of 8+ years in the pharmaceutical/biotech industry.
• Extensive experience in CMC development.
• Professional proficiency in Mandarin preferred.

Responsibilities

• Drive success in CMC, Supply, Quality, and Business activities.
• Ensure alignment in CMC strategy for regulatory filings.
• Monitor CDMO performance against KPIs and manage risks.

Skills

Leadership of cross-functional teams

Integrated project planning

Risk management

Communication skills

Education

Bachelor’s degree in life sciences or related field

Advanced degree (MS, PharmD, PhD, MBA)

Tools

Smartsheet

MS Project

Power-BI

Job description

A leading biotech firm in Princeton, NJ seeks an Associate Director for CMC/Quality Project Management. The ideal candidate will have extensive experience in CMC development and regulatory processes, overseeing biologics from early phases to BLA submission. Strong leadership skills and proficiency in project management tools required. This role offers a competitive salary and the opportunity to drive impactful programs in the company.