Lead, Process Engineer
Posted on: November 21, 2022
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
- 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
- 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
- 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
- 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
- Must be able to function independently and influence
appropriate stakeholders and recommend scientifically rigorous,
risk-management-based solutions to complex technical
- Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC
- Experience working with contract manufacturing
- 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.
Keywords: Amylyx, Cambridge , Lead, Process Engineer, Engineering , Cambridge, Massachusetts
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