Director, Process Development (Pivotal & Commercial)

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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.

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.

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