Manager, Quality Control and Analytical Development

The posting, as Amylyx Pharmaceuticals wrote it

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 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 p

[…]
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.

Base salary is one component of Amylyx’s total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company’s long-term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees.

Estimated Pay Range
$125,000 — $141,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn .

To return to our website please click here .

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.