Amylyx Pharmaceuticals
Associate Director, Drug Substance
Amylyx Pharmaceuticals, Cambridge, Massachusetts, us, 02140
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. The role is an individual contributor but highly collaborative and visible. 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. Work with contract manufacturing organizations to develop scalable and robust manufacturing processes for oligonucleotides and peptide products
Evaluate new CDMOs to support toxicology 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, 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 collaborate with project teams
Provide input to project timelines and budgets and communicate progress
Regularly interact 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
Required Qualifications
Bachelor’s degree in organic chemistry, chemical engineering, or related field. MS preferred
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
Strong track record of successful global CMC submissions and approvals
Must be able to function independently and influence stakeholders; 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
Remote work opportunities are supported within the United States, except for employees residing in certain states (Alaska, Arizona, Hawaii, Michigan, Tennessee)
Employees will be expected to travel to the corporate location in Cambridge, MA several times a year and attend other company‑related events as necessary and requested
Remote employees must have a setting that enables meeting all role requirements (privacy, reliable internet, phone, ability to video conference)
To stay connected with us follow Amylyx Pharmaceuticals on LinkedIn.
Equal Opportunity Employer Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in the selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr
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. The role is an individual contributor but highly collaborative and visible. 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. Work with contract manufacturing organizations to develop scalable and robust manufacturing processes for oligonucleotides and peptide products
Evaluate new CDMOs to support toxicology 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, 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 collaborate with project teams
Provide input to project timelines and budgets and communicate progress
Regularly interact 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
Required Qualifications
Bachelor’s degree in organic chemistry, chemical engineering, or related field. MS preferred
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
Strong track record of successful global CMC submissions and approvals
Must be able to function independently and influence stakeholders; 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
Remote work opportunities are supported within the United States, except for employees residing in certain states (Alaska, Arizona, Hawaii, Michigan, Tennessee)
Employees will be expected to travel to the corporate location in Cambridge, MA several times a year and attend other company‑related events as necessary and requested
Remote employees must have a setting that enables meeting all role requirements (privacy, reliable internet, phone, ability to video conference)
To stay connected with us follow Amylyx Pharmaceuticals on LinkedIn.
Equal Opportunity Employer Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in the selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr