Director, Assay Development and Biomarkers
Korro Bio, Inc.
Director, Drug Substance
Amylyx Pharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Lead CMC drug substance phase-appropriate development activities to ensure Module 3 content that supports global clinical filings and registration plans
- Serve as the technical SME and process owner for drug substance; develop scalable and robust manufacturing processes for oligonucleotides and peptide products with CDMOs
- Author IND and NDA Module 3 content, Master Batch Records, Validation Plans and Reports
- Ensure robust regulatory plans for changes while minimizing risk to product supply
- Foster effective teamwork and drive project execution; track critical path activities, anticipate risks, create contingency plans, update timelines and budgets, and maintain the CMC program plan
- Regularly interact with Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development
- Manage external resources including consultants and contractors as needed
- Travel to global manufacturing sites to support operations and validation activities
Requirements
- Bachelor’s degree in organic chemistry, chemical engineering, or related field (MS or PhD preferred)
- A solid understanding of small molecule, RNA, and amino acid chemistries
- At least 15 years of experience in API development from early through late-phase
- Prior process validation experience preferred
- Experience developing oligonucleotide and/or synthetic peptide processes including impurity control strategies
- Experience leading global, cross-functional, high performing teams
- Prior experience leading or serving on a CMC team preferred
- Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
- A strong track record of successful global CMC submissions and approvals
- Ability to function independently and influence stakeholders and recommend scientifically rigorous, phase appropriate, risk-management based solutions
- Experience working with contract manufacturing organizations
- Excellent communication and teamwork skills
- Ability to travel internationally up to 10%
