Director, Analytical Development — Innovative Science Lead

Gilead Sciences Inc.; Foster City (CA); In loco; USD 226.000 - 293.000; Tempo pieno

Descrizione del lavoro

Gilead Sciences Inc. seeks a Director of Analytical Development to lead a team responsible for analytical strategy from candidate nomination through commercial approval across small molecule portfolios.

You will manage method development, control strategies, and technology innovation while collaborating with Research, Regulatory Affairs, Process Chemistry, and Manufacturing to align with regulatory expectations and product understanding.

Competenze

• Ph.D. in Analytical Chemistry or related with 8+ years in pharma/biotech analytical development.
• Strong leadership and team-building experience guiding sizeable scientific teams.
• Deep knowledge of ICH guidelines, cGMP and global regulatory expectations.

Mansioni

• Define and implement end-to-end analytical development strategy across the portfolio.
• Mentor scientists, lead cross-functional governance, and collaborate with Regulatory Affairs, Process Chemistry, and QC.
• Develop and transfer analytical methods (HPLC/UPLC, GC, dissolution, KF, spectroscopy) per ICH and development stage.
• Drive QbD, data integrity, and modern analytical technologies to improve productivity.
• Prepare and support regulatory submissions (IND/IMPD, NDA/MAA) and respond to health authority questions.
• Oversee budget, resources, and portfolio prioritization within Analytical Development.

Conoscenze

People management

Analytical development

HPLC/UPLC

ICH guidelines

Regulatory submissions

Cross-functional leadership

Formazione

Ph.D. in Analytical Chemistry or related

Strumenti

LIMS/ELN

Digital lab initiatives

Descrizione del lavoro

Gilead Sciences Inc. seeks a Director of Analytical Development to lead a team responsible for analytical strategy from candidate nomination through commercial approval across small molecule portfolios.

You will manage method development, control strategies, and technology innovation while collaborating with Research, Regulatory Affairs, Process Chemistry, and Manufacturing to align with regulatory expectations and product understanding.