Quality Control & Analytical Development Manager

Amylyx Pharmaceuticals, Inc.; United States; A distancia; USD 125.000 - 141.000; Jornada completa

Descripción de la vacante

Amylyx Pharmaceuticals, Inc. is seeking a Manager of QC/AD to lead analytical development supporting peptide, antisense oligonucleotide, and small molecule programs.

This role requires GMP experience, external QC/AD management, and collaboration with Regulatory, Quality, and Manufacturing to ensure compliant release and stability testing across programs. The position offers remote work within the United States with periodic travel to Cambridge, MA and other sites as needed.

Formación

• BA/BS, MS or PhD in chemistry, biochemistry or related discipline.
• 5+ years in biotech/pharma with at least 3 years in QC/Analytical Development.
• Analytical methods for peptides/oligonucleotides include HPLC/UPLC, LC-MS, GC.
• Ability to analyze, trend, interpret and present data; JMP preferred.
• Experience managing external GMP QC/AD teams is preferred.
• Background in sterile drug product and environmental monitoring investigations is a plus.
• Knowledge of cGMP/ICH/FDA/EU/PMDA regulations.
• Strong collaboration and communication; multitasking in a fast-paced environment.

Responsabilidades

• Plan, coordinate and manage routine release testing and stability programs with CMOs and CTLs.
• Manage tech transfer of method development to support product characterization, release and stability.
• Technical review and trend analysis of data across API, DS and DP.
• Drive analytical investigations of OOS, deviations, CAPAs, and temperature excursions with CMOs/CTLs.
• Support QC GMP systems by maintaining reference standards and reagents.
• Author, review and approve documentation including reports, SOPs, test methods, specs and CMC sections.
• Collaborate cross-functionally with Preclinical R&D, External Manufacturing, Regulatory and Quality leadership.

Conocimientos

Cross-functional collaboration

Strong communication

Prioritization & multitasking

Analytical mindset

Attention to detail

Educación

BA/BS/MS or PhD in chemistry/biochemistry or related discipline

Herramientas

HPLC/UPLC

LC-MS

GC

JMP

Descripción del empleo

Amylyx Pharmaceuticals, Inc. is seeking a Manager of QC/AD to lead analytical development supporting peptide, antisense oligonucleotide, and small molecule programs.

This role requires GMP experience, external QC/AD management, and collaboration with Regulatory, Quality, and Manufacturing to ensure compliant release and stability testing across programs. The position offers remote work within the United States with periodic travel to Cambridge, MA and other sites as needed.