Senior QC & Analytical Development Leader

Merida Biosciences; Cambridge (MA); Sur place; USD 160 000 - 190 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

Competitive salary

Résumé du poste

A biotechnology company in Cambridge is looking for a Senior Manager/Associate Director in Quality Control and Analytical Development. The role involves overseeing CDMO activities for analytical methods and stability programs, with a strong emphasis on teamwork and innovative problem-solving. Ideal candidates should have over 8 years of experience in biologics development, especially in monoclonal antibodies, and be familiar with relevant regulations and analytical techniques. Competitive salary between $160,000-$190,000, along with a comprehensive benefits package, is offered.

Qualifications

• 8+ years of relevant experience in biologics drug development.
• Expertise in HPLC, CE-SDS, icIEF, spectroscopy, ELISA.
• Strong understanding of cGMP/ICH/FDA/EU regulations.

Responsabilités

• Oversee CDMOs for analytical method development and validation.
• Manage stability programs and troubleshoot QC method performance.
• Author and review CMC sections for regulatory filings.

Connaissances

Analytical techniques for biologics

Strong interpersonal and communication skills

Experience with HPLC and ELISA

Formation

Bachelor’s Degree in relevant discipline

PhD or MS in relevant discipline

Outils

HPLC

LC-MS

Spectroscopy

Description du poste

A biotechnology company in Cambridge is looking for a Senior Manager/Associate Director in Quality Control and Analytical Development. The role involves overseeing CDMO activities for analytical methods and stability programs, with a strong emphasis on teamwork and innovative problem-solving. Ideal candidates should have over 8 years of experience in biologics development, especially in monoclonal antibodies, and be familiar with relevant regulations and analytical techniques. Competitive salary between $160,000-$190,000, along with a comprehensive benefits package, is offered.