Biologics Analytical Development Director

Biopharma Careers; Foster City (CA); On-site; USD 243,000 - 315,000; Full time

Benefits offered by this job

Benefits package

Medical, dental, vision

Job summary

Gilead Sciences, located in Foster City, CA, seeks a Senior Director to lead Analytical Development for pivotal and commercial biologics. You will guide a team of ~20 scientists, oversee analytical strategy, and ensure robust control strategies to support regulatory filings and late-stage development.

You will collaborate with Quality, Manufacturing, CMC Regulatory Affairs, and Clinical Development to deliver on ambitious biologics programs, adopting state-of-the-art technologies while

Qualifications

• PhD or equivalent with 12+ years of industrial experience in biologics analytical development.
• Extensive experience with analytical method development and control strategies for biologics.
• Expert in mass spectrometry, biophysical techniques and separation methods used for biologics characterization.
• Proven ability to draft and defend regulatory documents (IND, BLA, PAS) and collaborate across CMC functions.

Responsibilities

• Provide leadership to a group of analytical development scientists; mentor and guide staff.
• Oversee budgeting for capital equipment.
• Set clear expectations and prioritization of work packages.
• Manage workload and resources effectively.
• Lead extended characterization studies using MS and biophysical techniques.
• Define phase-appropriate analytical comparability strategies for pivotal and post-approval changes; include risk assessment and regulatory justification.
• Establish state-of-the-art analytical laboratory; drive adoption of new analytical technologies.
• Guide CMC sections in regulatory filings and support interactions with health agencies.
• Collaborate with PDM, Quality, Supply Chain, Regulatory Affairs and Clinical Development to ensure timely delivery and successful commercialization.
• Demonstrate knowledge of cGMP practices; shape late-stage development strategies.
• Drive strategic areas including CQAs, methods, references and specifications.

Skills

Leadership

Analytical development

Regulatory strategy

Cross-functional collaboration

People management

Education

PhD with 12+ years

Tools

Mass spectrometry

Biophysical techniques

Separation methods

Automation

Job description

Gilead Sciences, located in Foster City, CA, seeks a Senior Director to lead Analytical Development for pivotal and commercial biologics. You will guide a team of ~20 scientists, oversee analytical strategy, and ensure robust control strategies to support regulatory filings and late-stage development.

You will collaborate with Quality, Manufacturing, CMC Regulatory Affairs, and Clinical Development to deliver on ambitious biologics programs, adopting state-of-the-art technologies while