Associate Director, Drug Substance - Remote

Overview

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and determination, we encourage you to read the opportunity below and apply.

The Opportunity

Amylyx is looking for an Associate 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. This role will be an individual contributor, however, it is a 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 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. Working 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. Serve as the technical SME on all DS tech transfer projects
• Monitor drug substance GMP operations including clinical batch record review, and process data trending and support of related quality events.
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Understand regulatory plans for all proposed changes, 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.
• Provide input to project timelines and budgets and communicate progress
• Regularly interacts 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

Requirements

• Bachelor’s degree in organic chemistry, chemical engineering, or related field. MS preferred
• A solid 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
• 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%

Benefits

• Remote work opportunities within the United States
• Collaborative and supportive work culture
• Opportunity to work on innovative therapies
• Professional growth and development
• Dynamic team environment