Associate Director, ECO Process Development
Codexis, Inc.
Director, Analytical Development and Clinical Quality Control
Disc Medicine
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteJob Level
Lead
About the role
- Report to Head of ADQC in Technical Operations and lead the clinical QC function for Disc Medicine biologics pipeline programs from early development to commercialization
- Support selection, negotiation, and review of service agreements and statements of work with analytical and QC CDMOs
- Develop and manage relationships with external CDMO partners to ensure appropriate scopes of work and program expectations
- Guide qualification and validation of analytical methods to support GMP in-process, batch release and stability studies; review and approve protocols and reports
- Establish training and technical approaches to transfer analytical methods between development and QC testing sites
- Establish and implement product specifications, oversee outsourced GMP release testing, stability programs, and reference standard management at CDMOs
- Accountable for QC OOS/OOT/deviation investigations and identification of root cause and CAPA for testing-related issues
- Support quality assurance in product release activities and product shelf-life management
- Establish systems and procedures for product and reference standard trending and review trend reports periodically
- Author, review, and approve SOPs, protocols, reports, and change controls; support annual product review and annual report activities
- Represent quality control operations in regulatory and partner audits and author/review global health authority CMC dossier sections for clinical trials and commercial licensure
- Foster a positive workplace culture that prioritizes collaboration, accountability, and continuous improvement
Requirements
- B.S. degree is required; M.S./Ph.D. preferred
- 12+ years of related experience in the biopharmaceutical industry
- Comprehensive knowledge of cGMP and global regulatory requirements
- Prior experience in leading quality control functions
- Experience in IND and BLA filings is highly desired
- Expert knowledge of biopharmaceutical drug development from pre-clinical to post-approval changes
- Working knowledge and experience in quality systems, product specification establishment, analytical method validation, transfer, and method lifecycle management
- Ability to collaborate well with cross-functional groups, including Process Development, Manufacturing, Quality, Regulatory and Program Management
- Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment and prioritize on tight timelines
- Excellent communication and interpersonal skills; ability to convey complex ideas succinctly
