Director – Drug Substance

The Opportunity

Amylyx is looking for a Director, Drug Substance, to join our CMC and External Manufacturing team. In this role you will be the technical development drug substance owner for Amylyx’s Phase III synthetic peptide, Avexitide, and pre-clinical antisense oligonucleotide, AMX-0114. This position will work directly with external CDMOs to develop, scale-up, and validate drug substance processes. Initially this role will be an individual contributor, however, may evolve into a functional head. In this highly collaborative and visible role, you will be a key member of asset CMC teams. This role reports to the Senior Vice President, Global CMC and External Manufacturing.

Responsibilities

• 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. Working with contract manufacturing organizations, develop scalable and robust manufacturing processes for oligonucleotides and peptide products
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Ensure robust regulatory plans for all changes while minimizing risk to product supply
• Foster effective teamwork and drive project execution. Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams. Update project timelines and budgets, communicate progress, and maintain the CMC program plan
• Regularly interacts with functional areas including Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development
• Manage external resources including Consultants and Contractors, as needed to deliver projects
• Travel to global manufacturing sites to support operations and validation activities

Required Qualifications

• 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
• Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, phase appropriate, risk-management based solutions to complex technical challenges
• Experience working with contract manufacturing organizations
• Excellent communication and teamwork skills
• Ability to travel internationally up to 10%

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.