Senior QC & Analytical Development Lead

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remote; USD 125,000 - 141,000; Full time

Job summary

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

Qualifications

• 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

Responsibilities

• 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

Skills

Communication skills

Data analysis

Team collaboration

Prioritization

Education

Bachelor/Master/PhD in chemistry or biochemistry

Tools

HPLC/UPLC

LC-MS

GC

JMP

Job description

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