Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is seeking a Manager of Quality Control and Analytical Development to manage analytical development for pipeline products. The role supports phase-appropriate method development, qualification and validation, GMP release and stability testing, and collaboration with external partners and cross-functional teams.
Responsibilities
- Plan, coordinate and manage routine release testing and applicable stability programs at external CMOs and CTLs
- Manage the technology transfer of method development, qualification and validation activities to support product characterization, release and stability across multiple programs
- Technical review and trend analysis of in process, release and stability data across active pharmaceutical ingredients (API), drug substance (DS) and drug product (DP)
- Drive all analytical investigations of OOS, deviations, change controls, CAPAs, temperature excursions and troubleshooting with CMO/CTLs
- Support QC GMP systems by maintaining reference standard, critical reagent and method performance programs
- Author, review and approve documentation including technical reports, SOPs, test methods, specifications and CMC sections of regulatory filings
- Collaborate cross functionally with teams including Preclinical R&D, External Manufacturing, Regulatory and Quality leadership to develop strategies and deliver on key objectives
Skills
- BA/BS, MS or PhD in chemistry, biochemistry or related discipline
- 5+ years of experience working in the biotech and/or pharmaceutical industry with at least 3 years in Quality Control/Analytical Development
- Technical knowledge of analytical methods for peptides and/or oligonucleotide products including HPLC/UPLC, LC-MS, GC
- Ability to analyze, trend, interpret, organize and present data
- Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations
- Highly collaborative team player with strong communication skills
- Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
- Experience with JMP and/or other statistical software
- Experience managing external GMP QC/AD teams at manufacturing and testing partners
- Background in sterile drug product and environmental monitoring investigations experience
Benefits
- Remote work opportunities within the United States, except employees residing and/or working in Alaska, Arizona, Hawaii, Michigan, and Tennessee; travel to the corporate location in Cambridge, MA several times a year is expected.
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