Associate Director, Quality Control & Analytical Development

Amylyx Pharmaceuticals • Cambridge, MA

2h • $164,000 - $184,000 • Remote

About The Position

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.

Requirements

• 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.
• 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

Nice To Haves

• Environmental monitoring investigations to support sterile drug product experience is a plus.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree