Director, Process Development (Pivotal & Commercial)

Gilead Sciences•Foster City, CA

1d•$226,185 - $292,710

About The Position

Gilead is seeking a Director, Process Development to define and execute purification development strategy for a portfolio of pivotal, commercial, and lifecycle-management biologics programs. The role provides scientific and technical direction across process development, characterization, scale-up, validation readiness, technology transfer, and commercial manufacturing support. It oversees development of robust, manufacturable drug substance purification processes, including harvest clarification, chromatography, virus inactivation and filtration, ultrafiltration/diafiltration, formulation, and final drug substance filtration. The Director leads risk-based process characterization and control strategy work, supports technology transfers and commercial manufacturing activities, and provides technical leadership for regulatory content and health-authority interactions. The position also advances new technologies and data-driven development methods while leading, coaching, and developing a team of scientists and engineers. The Director establishes priorities, roles, decision rights, objectives, and performance expectations, and fosters an inclusive, collaborative, accountable, and learning-oriented team culture.

Requirements

PhD with 8 or more years of relevant experience, or MS with 10 or more years, or BS with 12 or more years.
Relevant education and experience in chemical engineering, biochemical engineering, biochemistry, bioengineering, biotechnology, pharmaceutical sciences, or a related scientific discipline.
Extensive experience in biologics purification process development, characterization, scale-up, technology transfer, validation readiness, or commercial manufacturing support.
Demonstrated experience leading complex process-development programs or a portfolio of related activities.
Strong knowledge of downstream processing and biologics manufacturing.
Experience developing process control strategies and translating process understanding into manufacturing controls.
Knowledge of cGMP manufacturing, process validation, data integrity, regulatory submissions, and lifecycle management.
Experience authoring, reviewing, or providing technical leadership for CMC documentation.
Demonstrated experience leading and developing scientists or engineers.
Proven ability to lead cross-functional work and influence stakeholders across organizational levels.
Excellent scientific judgment, decision-making, communication, technical writing, presentation, and stakeholder management skills.

Nice To Haves

Two or more years of direct people leadership experience.
Experience supporting pivotal or commercial-stage monoclonal antibodies, complex proteins, bispecific antibodies, antibody-drug conjugates, or other advanced biologics.
Experience supporting BLAs, MAAs, post-approval filings, health-authority responses, or regulatory inspections.
Experience with process performance qualification, continued process verification, comparability assessments, manufacturing investigations, and post-approval changes.
Experience transferring biologics drug substance processes to internal manufacturing sites, external partners, or contract development and manufacturing organizations.
Knowledge of viral clearance and associated regulatory expectations.
Experience applying quality risk management, design of experiments, statistical analysis, scale-down models, process modeling, automation, or high-throughput process development.

Responsibilities

Define and execute purification development strategy for pivotal, commercial, and lifecycle-management biologics programs.
Provide scientific and technical direction for process development, characterization, scale-up, validation readiness, technology transfer, and commercial manufacturing support.
Oversee development of robust and manufacturable drug substance purification processes, including harvest clarification, chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, formulation, and final drug substance filtration.
Direct risk-based process characterization strategies, scale-down model development, process parameter evaluation, and scientifically justified process control strategies.
Provide technical support for technology transfers to internal manufacturing sites, external partners, and contract development and manufacturing organizations.
Partner with Manufacturing Sciences and Technology and Manufacturing on engineering runs, process performance qualification, investigations, continued process verification, comparability assessments, and post-approval changes.
Provide technical leadership for purification-related regulatory content, health-authority responses, and inspection support.
Identify and communicate technical risks, development options, resource requirements, and recommendations to functional and cross-functional stakeholders.
Advance new technologies, platforms, automation, high-throughput experimentation, modeling, and data-driven development approaches.
Lead, coach, and develop a high-performing team of scientists and engineers.
Establish clear priorities, roles, decision rights, development objectives, and performance expectations.
Model inclusive leadership; coach employees, provide meaningful feedback, and create development opportunities; connect team objectives to organizational priorities, clarify accountability, remove barriers, and support team autonomy and success.