Associate Director, Drug Substance

Role Summary

Associate Director, Drug Substance at Amylyx, leading CMC drug substance development and acting as technical SME for DS processes, with external manufacturing collaboration. Reports to the Senior Vice President, Global CMC and External Manufacturing.

Responsibilities

• Lead CMC drug substance phase-appropriate process development activities from Phase 1 through NDA, ensuring Module 3 content supports global clinical filings and registration plans
• Serve as the technical SME and process owner for drug substance; with contract manufacturing organizations, develop scalable and robust manufacturing processes for oligonucleotides and peptide products
• Evaluate new CDMOs to support tox and clinical material needs; act as technical SME on all DS tech transfer projects
• Monitor drug substance GMP operations including clinical batch record review and process data trending, and support related quality events
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Understand regulatory plans for proposed changes, minimizing risk to product supply
• Foster effective teamwork and drive project execution; track critical path activities, anticipate risks, create contingency plans and decision-making exercises with project teams
• Provide input to project timelines and budgets and communicate progress
• Regularly interact with key CMC team members including Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing
• Travel to global manufacturing sites to support operations and validation activities

Qualifications

• Bachelor‚Äôs degree in organic chemistry, chemical engineering, or related field; MS preferred
• Understanding of small molecule, RNA, and amino acid chemistries
• At least 5 years of experience in API process development from early through late-phase; prior process validation experience preferred
• Experience developing oligonucleotide and/or synthetic peptide manufacturing processes including impurity control strategies
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
• Track record of successful global CMC submissions and approvals
• Ability to function independently and influence stakeholders; provide scientifically rigorous, phase-appropriate, risk-managed solutions
• Experience working with contract manufacturing organizations
• Excellent communication and teamwork skills
• Ability to travel internationally up to 10%

Skills

• CMC strategy and regulatory submission expertise
• Tech transfer and manufacturing process development for DS
• Oligonucleotide and peptide process development
• Quality systems and GMP compliance
• Project management and cross-functional collaboration

Education

• Bachelor‚Äôs degree in organic chemistry, chemical engineering, or related field; MS preferred

Additional Requirements

• Travel to international sites up to 10%; willingness to relocate if necessary