Senior Director, Biologics Analytics & Strategy

Generate:Biomedicines; Somerville (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

Generate:Biomedicines is seeking a Senior Director, Analytical Development to set strategic direction for analytical development of biologics in a lean, fully virtual model. The leader will drive analytical strategy, method lifecycle management, release and stability testing, comparability, and CDMO collaboration, reporting to the VP of Technical Operations.

The role oversees a small senior team and partners with QA, Regulatory, and CMC to ensure inspection readiness and regulatory submissions.

Qualifications

• Ph.D. in Biochemistry, Analytical Chemistry, or related field with 15+ years of industry experience, or M.S. with significant equivalent experience.
• Deep expertise in analytical development and QC for biologics including antibodies and fusion proteins.
• Experience leading analytical strategy from candidate through commercialization readiness.

Responsibilities

• Define long-term analytical development strategy and external partner network for biologics portfolio.
• Lead development and execution of analytical strategies for protein therapeutics through late-stage development.
• Establish phase-appropriate analytical control strategies including method development, qualification, validation, and stability programs.
• Serve as senior analytical partner to cross‑functional teams (CMC, Process Development, MS&T, Quality, Regulatory).
• Build and lead a high-performing analytical organization and manage external partner performance.

Skills

Analytical development

Quality control

GMP compliance

Leadership

External partnerships

Education

Ph.D. in Biochemistry/Analytical Chemistry or related

M.S. with extensive experience

Tools

HPLC/LC-MS

Job description

Generate:Biomedicines is seeking a Senior Director, Analytical Development to set strategic direction for analytical development of biologics in a lean, fully virtual model. The leader will drive analytical strategy, method lifecycle management, release and stability testing, comparability, and CDMO collaboration, reporting to the VP of Technical Operations.

The role oversees a small senior team and partners with QA, Regulatory, and CMC to ensure inspection readiness and regulatory submissions.