Amylyx Pharmaceuticals · 5 hours ago
Senior Director, CMC
Cambridge, MA
Full-time
Hybrid
Director/Executive
$246K/yr - $277K/yr
15+ years expAmylyx is a clinical-stage company focused on treating diseases with high unmet needs. They are seeking a Senior Director, Chemistry, Manufacturing, and Controls (CMC) to lead the CMC organization in developing their pipeline and ensuring compliance with regulatory standards.
BiotechnologyMedicalNeurosciencePharmaceutical
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
Qualification
Required
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. Prior process validation experience preferred
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%
Company
Amylyx Pharmaceuticals
Amylyx Pharmaceuticals specializes in providing solutions for Alzheimer’s and other diseases of the brain.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$623.45MKey Investors
Viking Global InvestorsMorningside
2025-09-10Post Ipo Equity· $175M
2022-10-06Post Ipo Equity· $246.3M
2022-01-07IPO
Leadership Team
Jim Frates
Chief Financial Officer
Camille Bedrosian
Chief Medical Officer
Recent News
BioWorld Financial Watch
2026-01-11
Longevity.Technology
2026-01-11
Company data provided by crunchbase