Job description
Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and determination, we encourage you to read the opportunity below and apply.
THE OPPORTUNITY
The Quality team is expanding and looking to hire a Manager of QC/AD, reporting to the Director of QC/AD. This individual will be responsible for managing all analytical activities to support release and stability testing of our clinical and commercial products across multiple programs with several external CMO/CTLs. The ideal candidate will be a motivated, self-starter, well versed in GMPs and excited about the potential to deliver therapies to patients in need.
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.
REQUIRED QUALIFICATIONS
- 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)
- Experience managing external GMP quality control teamsat manufacturing and testing partners a plus
- 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
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, Delaware, Hawaii and Kansas.
- 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.
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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
