Manager, Quality Control & Analytical Development

Summary

Join Amylyx Pharmaceuticals as a Manager of QC/AD, managing all analytical activities for clinical and commercial products. You will plan and coordinate testing, lead technology transfers to CMOs/CTLs, review data, manage release and stability data, support QC GMP systems, author and review SOPs, drive investigations, support method development, collaborate cross-functionally, and work with regulatory affairs. The role requires a BS or MS in a related field, 5+ years of experience in QC/Analytical Development in biotech/pharma, and expertise in analytical methods. Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations and technical writing skills are essential. This remote position, based in the US (excluding specific states), requires travel to Cambridge, MA, several times a year.

Requirements

• BS or MS in Chemistry, Biochemistry, Biology or other related field
• 5+ years of experience working in the Biotech and/or pharmaceutical industry specifically within Quality Control/Analytical Development
• Technical knowledge of analytical methods for small molecules, 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)
• Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations
• Demonstrated knowledge of USP, EP, and JP monographs
• Technical writing expertise for Standard Operating Procedures (SOPs) and method validation protocols/reports
• Highly collaborative team player with strong communication skills
• Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities

Responsibilities

• Plan, coordinate, and manage routine testing and associated stability programs at external CMOs and CTLs
• Lead the technology method transfer to CMO/CTLS including execution and management of the development, qualification, and validation of methods 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)
• Manage release and stability data for Certificate of Analysis generation and shelf-life assignment to partner with Supply Chain and Logistics teams ensuring clinical and commercial supply of drug product
• Support of QC GMP systems including maintaining the reference standard and critical reagent programs as well as method performance monitoring
• Author, review and approve SOPs, specifications, stability protocols/reports, method validation and method transfer protocols/reports
• Drive all analytical investigations of OOS, deviations, change controls, CAPAs, temperature excursions and troubleshooting with CMO/CTLs
• Support analytical method establishment and development to characterize pre-clinical products within Amylyx pipeline
• Collaborate cross functionally with manufacturing and technical operations to ensure methods support manufacturing changes and clinical/commercial readiness
• Proactively identify and troubleshoot issues to ensure program timelines and identify opportunities for improvement of QC operations internally and at external CMOs/CTLs
• Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial filings (IND, IMPD, NDA, BLA) as needed

Preferred Qualifications

Experience managing external GMP quality control teams at manufacturing and testing partners a plus

Benefits

At Amylyx, we proudly support remote work opportunities within the United States