Senior Director, CMC

Amylyx Pharmaceuticals•Cambridge, MA

7d•$246,000 - $277,000•Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating 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 are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Amylyx is looking for a highly experienced Senior Director, Chemistry, Manufacturing, and Controls (CMC), to lead the CMC organization to develop Amylyx’s pipeline including Phase III synthetic peptide, Avexitide, and Phase I antisense oligonucleotide, AMX0114. The CMC group works with external CDMOs to develop robust, scalable, compliant processes for clinical and commercial supply. The Senior Director may lead directly or manage the leads of internal matrix CMC Asset teams and represent CMC on Asset program teams. This leader will work cross-functionally to drive technical excellence and ensure CMC readiness and alignment to program goals. The ideal candidate will combine strong strategic leadership while working closely with teams and actively contributing to hands-on execution when needed. This role reports to the Senior Vice President, Global CMC and External Manufacturing.

Requirements

Advanced degree in chemistry, chemical engineering, or related field.
A solid understanding of small molecule, RNA, and peptide/amino acid chemistries.
At least 15 years of experience in technical process development from early through late phase.
Expertise in developing phase-appropriate oligonucleotide and/or synthetic peptide manufacturing processes.
Advanced knowledge of cGMP/GLP regulations, ICH, FDA, EMA, JP CMC Guidance Documents.
A strong track record of successful global CMC submissions and approvals.
Must be able to function independently, influence appropriate stakeholders, and build relationships internally and externally.
Experience partnering with contract manufacturing organizations.
Excelling leadership, communication, and collaboration skills.
Ability to travel internationally up to 10%.

Nice To Haves

Prior process validation experience preferred.

Responsibilities

Partner with Regulatory, Quality, Analytical Development, Supply Chain, and External Manufacturing teams to execute CMC strategies for drug development from early-phase through commercialization aligned with asset development plans.
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 guidance on timelines, budgets, and risk mitigation strategies.
Evaluate new CDMOs to support tox and clinical material needs.
Provide technical leadership for all due diligence and tech transfer projects.
Travel to global manufacturing sites to support development operations and foster collaboration.
Manage CMC leads and/or lead key matrix CMC Asset teams when needed.
Author and/or review CMC sections of IND, NDA, and global regulatory submissions (Module 3).
Ensure compliance with cGMP, ICH guidelines, and FDA CMC requirements.
Lead phase-appropriate process development, optimization, and validation activities.
Recommend scientifically rigorous, phase-appropriate, risk management-based solutions to complex technical challenges.
Develop impurity control strategies and ensure processes meet global regulatory standards.
Serve as the technical subject matter expert (SME) and process owner when needed.
Drive successful technology transfers and monitor clinical manufacturing operations, including batch record review and data trending.
Lead and mentor a team of technical professionals, fostering a culture of collaboration, accountability, and continuous improvement.
Provide career development guidance, performance feedback, and succession planning for team members.
Allocate resources effectively across projects and ensure alignment with organizational priorities.
Promote technical excellence through coaching, training, and knowledge-sharing initiatives.
Drive engagement and retention by creating an inclusive and supportive work environment.