Head – CMC

THE OPPORTUNITY

Amylyx is looking for a Head of CMC, Peptides and Oligonucleotides, to join our CMC and External Manufacturing team. In this role you will lead CMC matrix teams as well as be the drug substance process owner for Amylyx’s Phase III synthetic peptide, Avexitide, and pre-clinical antisense oligonucleotide, AMX-0114. As the CMC team lead, this role will represent technical operations at asset program teams. In addition to the CMC team leadership, 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 managing the matrix CMC team, however, may evolve into a functional head. In this highly collaborative and visible role, you will be a key member of asset program teams. This role reports to the Head, Global CMC and External Manufacturing.

THE RESPONSIBILITIES

• Lead CMC teams to identify and prioritize development activities to ensure phase appropriate 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 biology, chemistry, chemical engineering, or related field. MS or PhD preferred
• At least 15 years of experience in technical development including prior oligonucleotide and/or peptide process development within the pharmaceutical industry
• 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%
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WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.