Director, Process Engineering & Materials Science

Job Description

Director, Process Engineering & Materials Science

Foster City, CA

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

This position will represent a new Process Engineering function as part of the Materials Sciences group, under the Process Chemistry organization.

Responsibilities:

• Serve as the global leader of process engineering function within Gilead and provide engineering expertise to support chemical development and optimization across all scales for small to large molecules, ensuring and enabling robust, safe, and high-performing processes.
• Evaluate critical chemical processing strategies and unit operations for practicality, efficiency, and scalability to large-scale manufacturing.
• Evaluate innovative technologies and/or processing techniques to overcome technical challenges and/or to achieve targeted outcomes.
• Integrate engineering resources across multiple sites, functions, and modalities, and support drug development (small molecules & biologics) at all stages.
• Plan, design, and execute experiments to translate lab-scale understanding into robust process knowledge for drug substance and drug product manufacturing. Integrate study designs with process R&D (e.g., QbD, etc.) to enable robust knowledge and datasets to support a strong regulatory filing strategy and position.
• Collaborate with chemistry teams to develop and implement economical, state-of-the-art techniques for isolating, characterizing, purifying, and mass-producing drug substances.
• Serve as a subject matter expert and advisor to chemistry teams, providing guidance on development direction and strategy. Participate and/or lead industry consortia on process engineering to promote the science, share information, and learn/innovate/implement state-of-the-art technologies.
• Lead scientific innovation in engineering, identifying and implementing new technologies (e.g., flow chemistry, predictive tools, machine learning, etc.) to advance Gilead's capabilities.
• Support commercial teams in the launch of new products and life-cycle management in manufacturing, problem-solving, CPV, regulatory compliance, and process robustness enhancement.
• Participate in performance calibrations and individual development plan reviews.
• Contribute to building departmental objectives and policies in line with company goals.
• Contribute to department operations, including staffing assignments, budget allocation, performance calibrations, recruiting, and training programs.
• Advocate for quality and safety compliance within the department.

Skills and Qualifications:

• Excellent research and development experience and ability. Collaborative and creative mindset to explore and develop technologies to solve complex issues and challenges or drive toward a targeted outcome.
• Thorough understanding of API/BDS production in a GMP environment, including GMP compliance, process implementation, and operational excellence.
• Strong analytical and problem-solving skills with the ability to analyze complex situations and data, requiring ingenuity and creativity.
• Excellent hands-on experimental skills and experience in process development and scale-up.
• Demonstrated ability to think critically and creatively, work independently, and effectively manage resources.
• Innovative mindset and SME on state-of-the-art technologies and manufacturing techniques in industry. Ability to translate exploratory science and imaginative ideas to practical, effective, efficient, and scalable manufacturing options.
• Strong organizational and planning skills.
• Exceptional scientific communication skills (written and verbal) and interpersonal skills.
• Collaborative team player with a strong problem-solving spirit.
• In-depth knowledge of engineering principles and theories with the ability to apply them to support product development.
• Manages direct reports, including subordinate managers with people and project management responsibilities. Strong emphasis on developing colleagues, mentorship to individuals and project teams on strategy with influence beyond individual group members and programs.
• Recognized as a functional area expert within the department and across PDM.

Specific Education & Experience Requirements:

• Ph.D. in Chemical Engineering or Chemistry with at least 8 years of pharmaceutical industry experience
• MS degree in Chemical Engineering or Chemistry with at least 10 years of pharmaceutical industry experience
• BS degree in Chemical Engineering or Chemistry with at least 12 years of pharmaceutical industry experience
• Extensive experience scaling up synthetic routes and developing safe processes.
• Must think critically and creatively and be able to work independently to determine appropriate resources for the resolution of problems.