Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating 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 are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
The Quality Operations team is expanding and looking to hire an Associate Director of QC/AD, reporting to the Director of QC/AD. This individual will be responsible for managing analytical development activities to support the Amylyx pipeline including synthetic peptides, antisense oligonucleotides and small molecules. This individual will be responsible for leading phase appropriate analytical profiles of products spanning pre-clinical, clinical and commercial readiness. The ideal candidate will be a motivated, self-starter, willing to actively collaborate cross functionally and excited about the potential to deliver therapies to patients in need.
Responsibilities
- Lead phase-appropriate analytical control strategies for drug substance and drug product development, including specifications and initial shelf-life assignment.
- Leads method establishment, development and qualification for release, and stability testing of drug substance and drug product for peptides, oligonucleotide and other modalities.
- Manage and budget analytical activities at various global CMO/CTLS, including method technology transfer across Amylyx programs.
- Drive robust impurity characterization, profiling, and quantitation of drug substance and drug product across all stages of clinical development with a focus on HPLC and LC/MS.
- Lead method troubleshooting, optimization and life-cycle management for characterization, release and stability across multiple programs, through direct oversight of CMO/CTLS.
- Collaborate cross functionally with teams including Preclinical R&D, External Manufacturing, Regulatory and Quality leadership to develop strategies and deliver on key objectives.
- Author, review and approve documentation including technical reports, SOPs, test methods, specifications and CMC sections of regulatory filings.
- Travel may be required up to 10%, which may include on-site review of third-party laboratory and manufacturing operations.
Required Qualifications
- BA/BS, MS or PhD in chemistry, biochemistry or related discipline with at least 8+ years of experience.
- At least 6+ years of industry experience within Analytical Development and/or Quality Control.
- Technical expertise in the development of analytical methods for peptides and/or oligonucleotide products is required.
- Environmental monitoring investigations to support sterile drug product experience is a plus.
- 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
- 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, which may include travel by air, driving or public transportation.
- You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location.
Compensation
The 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.
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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.
Top Skills
Amylyx Cambridge, Massachusetts, USA Office
Cambridge, MA, United States, 02141
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