Lead – CMC Sterile Drug Product

THE OPPORTUNITY

Amylyx is looking for a Lead, CMC – Sterile Drug product to join our CMC team.  In this role you will provide formulation and drug product process development for Amylyx’s sterile injectable pipeline including Phase III synthetic peptide, Avexitide, and pre-clinical antisense oligonucleotide, AMX-0114. This position will lead development, scale-up, and validation for drug product processes at external CDMOs. In this highly collaborative role, you will be a key member of CMC matrix teams. This role reports to the Head, Global CMC and External Manufacturing.

THE RESPONSIBILITIES

• Technical SME and process owner –develop scalable manufacturing process for synthetic oligonucleotide and peptide drug products.
• 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

REQUIRED QUALIFICATIONS

• Prior experience with formulation development and sterile drug product process development including process validation, global regulatory requirements, and CMC filings. Prior experience in injectable device or combination products a plus
• 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; advanced degree in an applicable field desirable
• 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%

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.