Senior Director, External Manufacturing
Amylyx Pharmaceuticals
June 26, 2026
Remote
United States
Operations
Responsibilities:
- Provide strategic leadership and oversight of external manufacturing across clinical development and commercial supply.
- Establish and govern CDMO partnerships; ensure performance, accountability, and alignment with program objectives.
- Define and execute manufacturing strategies for technology transfer, scale-up, commercialization, and lifecycle management.
- Establish supplier performance metrics and business review processes.
- Mentor relationship owners serving as internal teams’ lead and supplier point of contact.
- Ensure supply continuity via proactive risk identification, mitigation planning, and issue escalation.
- Oversee technology transfer, manufacturing execution, and process performance across global external sites.
- Support commercial launch readiness (validation, supply planning, inspection preparedness).
- Partner cross-functionally with Finance, Legal, CMC, Quality, and Supply Chain.
- Build scalable external manufacturing infrastructure, operating models, and governance.
Required Qualifications:
- Bachelor’s degree in engineering/life sciences/related; advanced degree preferred.
- 15+ years in pharmaceutical/biotech manufacturing, including significant external manufacturing leadership.
- Proven track record managing CDMOs for clinical and commercial supply.
- Deep knowledge of cGMP and global regulatory expectations.
- Experience with manufacturing strategy, technology transfer, and commercialization.
- Strong leadership, communication, and stakeholder management.
- Experience supporting commercial launches, RFPs, supply agreement negotiations, and high-value budgets.
- Experience across API, drug product, packaging, and device.
- Ability to travel ~10%.
Preferred Qualifications:
- Experience across small molecule, peptide, and oligonucleotide modalities.
- Track record of process scale-up, validation, and continuous improvement.
Compensation:
- $245,000–$276,000 USD (estimated).
- Provide strategic leadership and oversight of external manufacturing across clinical development and commercial supply.
- Establish and govern CDMO partnerships; ensure performance, accountability, and alignment with program objectives.
- Define and execute manufacturing strategies for technology transfer, scale-up, commercialization, and lifecycle management.
- Establish supplier performance metrics and business review processes.
- Mentor relationship owners serving as internal teams’ lead and supplier point of contact.
- Ensure supply continuity via proactive risk identification, mitigation planning, and issue escalation.
- Oversee technology transfer, manufacturing execution, and process performance across global external sites.
- Support commercial launch readiness (validation, supply planning, inspection preparedness).
- Partner cross-functionally with Finance, Legal, CMC, Quality, and Supply Chain.
- Build scalable external manufacturing infrastructure, operating models, and governance.
Required Qualifications:
- Bachelor’s degree in engineering/life sciences/related; advanced degree preferred.
- 15+ years in pharmaceutical/biotech manufacturing, including significant external manufacturing leadership.
- Proven track record managing CDMOs for clinical and commercial supply.
- Deep knowledge of cGMP and global regulatory expectations.
- Experience with manufacturing strategy, technology transfer, and commercialization.
- Strong leadership, communication, and stakeholder management.
- Experience supporting commercial launches, RFPs, supply agreement negotiations, and high-value budgets.
- Experience across API, drug product, packaging, and device.
- Ability to travel ~10%.
Preferred Qualifications:
- Experience across small molecule, peptide, and oligonucleotide modalities.
- Track record of process scale-up, validation, and continuous improvement.
Compensation:
- $245,000–$276,000 USD (estimated).