Lead, CMC Sterile Drug Product

Summary

Join Amylyx Pharmaceuticals as a Lead, CMC – Sterile Drug Product and contribute to the development of potential treatments for neurodegenerative diseases. You will be responsible for formulation and drug product process development for sterile injectables, leading development, scale-up, and validation at external CDMOs. This highly collaborative role requires expertise in sterile drug product process development, regulatory requirements, and CMC filings. The position offers a remote-friendly work environment within the United States, with occasional travel to the Cambridge, MA office. Success in this role demands strong technical leadership, excellent communication, and teamwork skills. Amylyx is an equal opportunity employer committed to diversity and inclusion.

Requirements

• Prior experience with formulation development and sterile drug product process development including process validation, global regulatory requirements, and CMC filings
• BS in Chemistry, Chemical Engineering, or related field with a minimum of 8 years’ experience supporting sterile drug product formulation and process development and manufacturing
• Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, phase appropriate, risk-management based solutions to complex technical challenges
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
• Experience working with contract manufacturing organizations
• Excellent communication and teamwork skills
• Ability to travel internationally up to 10%

Responsibilities

• Serve as the CMC Technical Lead including authoring IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Act as the technical lead for regulatory submissions, inspections, and audits
• Work with contract manufacturing organizations to develop scalable and robust manufacturing processes for oligonucleotides and peptide products
• Provide technical leadership for vendor selection, process transfers and validations
• Manage external resources including Consultants and Contractors, as needed to deliver projects
• Travel to global manufacturing sites to support operations and validation activities
• Technical SME and process owner –develop scalable manufacturing process for synthetic oligonucleotide and peptide drug products

Preferred Qualifications

• Prior experience in injectable device or combination products
• Advanced degree in an applicable field

Benefits

Remote friendly role