Director, Process Development (Pivotal & Commercial)

Key Responsibilities

• Define and execute purification development strategy for a portfolio of 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 establishment of 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 to support 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.
• Foster an inclusive, collaborative, accountable, and learning-oriented culture consistent with Gilead's Leadership Commitments and People Leader Accountabilities.

Basic Qualifications

One of the following

• PhD with 8+ years of relevant experience;
• MS with 10+ years of relevant experience; or
• BS with 12+ years of relevant experience.

Additional information

Relevant education and experience should be in chemical engineering, biochemical engineering, biochemistry, bioengineering, biotechnology, pharmaceutical sciences, or a related scientific discipline.

Additional requirements

• 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.

Preferred Qualifications

• 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.

People Leader Accountabilities

• Create Inclusion: Model inclusive leadership and embed inclusion in team practices and decision-making.
• Develop Talent: Coach employees, provide meaningful feedback, and create development opportunities aligned with their capabilities and aspirations.
• Empower Teams: Connect team objectives to organizational priorities, clarify accountability, remove barriers, and provide the autonomy and support needed to succeed.

Pay and benefits

The salary range for this position is: $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Your Rights Under the Family and Medical Leave Act

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

• Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
• Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.