Manager, Quality Control and Analytical Development

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Teletrabalho; USD 125 000 - 141 000; Tempo integral

Resumo da oferta

Amylyx Pharmaceuticals, Inc. seeks an experienced QC/Analytical Development professional to lead release testing and stability programs with external CMOs and CTLs. You will drive method transfer, qualification, and validation activities, and review data trends across API, DS, and DP.

You will also lead OOS investigations and CAPAs, while documenting technical reports and regulatory filings. Remote-friendly role with travel to Cambridge, MA as needed; collaboration with Regulatory, External

Qualificações

• 5+ years in biotech/pharma with at least 3 years in QC/Analytical Development
• Experience with analytical methods for peptides/oligonucleotides like HPLC/UPLC, LC-MS, GC
• Strong data interpretation and trend analysis skills; proficient with JMP or similar software
• Experience managing external GMP QC/AD teams is preferred
• Background in sterile drug product and environmental monitoring investigations is a plus
• Solid knowledge of cGMP/ICH/FDA/EU/PMDA regulations
• Excellent cross-functional communication and ability to multi-task in a fast-paced environment

Responsabilidades

• Plan, coordinate and manage routine release testing and stability programs with external CMOs/CTLs
• Drive method transfer, qualification and validation activities
• Technical review and trend analysis of release/encapsulation data across API/DS/DP
• Lead investigations of OOS, deviations, CAPAs, and temperature excursions
• Support QC GMP systems including reference standards and test methods
• Author/review documentation for technical reports, SOPs, and regulatory filings
• Collaborate with Preclinical R&D, External Manufacturing, Regulatory and Quality leadership

Conhecimentos

Communication skills

Data analysis

Team collaboration

Prioritization

Formação académica

Bachelor/Master/PhD in chemistry or biochemistry

Ferramentas

HPLC/UPLC

LC-MS

GC

JMP

Descrição da oferta de emprego

The Opportunity

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.

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 present data (experience with JMP and/or other statistical software preferred)
• Experience managing external GMP QC/AD teams at manufacturing and testing partners is preferred
• Background in sterile drug product and environmental monitoring investigations experience is a plus
• 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.
• 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.

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.

Estimated Pay Range

$125,000 - $141,000 USD

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

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.