The OpportunityThe Quality Operations team is expanding and looking to hire a Manager of QC/AD, reporting to the Senior Director of QC/AD. This individual will be responsible for managing analytical development activities to support the Amylyx pipeline products including synthetic peptides, antisense oligonucleotides and small molecules. This individual will support phase appropriate analytical development, qualification/validation and oversight of GMP release and stability testing. The ideal candidate will be a motivated, self-starter, well versed in the GMPs, willing to actively collaborate cross functionally and excited about the potential to deliver therapies to patients in need.
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.
Requirements- 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 (experience with JMP and/or other statistical software preferred)
- Experience managing external GMP QC/AD teams at manufacturing and testing partners is preferred
- Background in sterile drug product and environmental monitoring investigations experience is a plus
- 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
Work Location and Conditions- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
- You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
CompensationThe pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.
Estimated Pay Range
$125,000-$141,000 USD
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