POSITION SUMMARY

In this role you will provide technical leadership and serve as the process owner for Amylyx’s small molecule, AMX-0035. This position will support all Amylyx assets throughout the product lifecycle, including process development, optimization, scale-up, validation, and continuous improvement. You will be the primary technical lead for process-related development, validation, and improvements; technical transfers; and ongoing manufacturing technical support. You will participate in long-term strategic planning and implementation of activities to meet forecasts, reduce supply risks, improve processes, reduce COGS, and support global expansion. This role reports to the Head, Global CMC and Technical Services.

RESPONSIBILITIES

• Technical SME and process owner - author, review, and approve regulatory and technical documentation, including but not limited to NDA, annual product reports, SOPs, Validation Master Plans, and Technical Reports; act as the technical lead for regulatory submissions, inspections, and audits.
• Provide technical impact assessments for process operations events and change control/CAPA as appropriate for quality system support.
• Troubleshoot process issues, monitor and evaluate process data, identify process trends and improvement opportunities for our Small Molecule API and Drug Product.
• Drive continuous improvement – work with CMOs to identify opportunities to improve the consistency and robustness of process operations.
• 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.

REQUIREMENTS

• Bachelor in Biology, Chemistry, Chemical Engineering, or related field with a minimum of 8 years experience supporting small molecule process development and manufacturing; advanced degree in an applicable field desirable
• Experience with small molecule product process development and/or manufacturing, process validation, global regulatory requirements, and CMC filings
• Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations and product impact assessments
• Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, 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

COVID-19 Vaccination Policy: Candidates should be aware that Amylyx’s current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.