Key Responsibilities:

Global Process Stewardship

• Own and maintain global process documentation, including Process Descriptions, Process Control Strategy, & process FMEAs for multi-site commercial processes
• Conduct global change control impact assessments to ensure process consistency across the network
• Support the development of a standardized documentation and governance framework to enable lifecycle management and harmonization

Project Leadership & Strategic Execution

• Lead high-priority, complex global MSAT projects spanning multiple sites, functions, and jurisdictions
• Contribute to Global MSAT project portfolio strategy, prioritization, and execution
• Drive cross-functional alignment and ensure reliable execution of network-level initiatives

Operational Excellence & Process Consistency

• Lead global investigations across sites to identify root causes and implement sustainable solutions
• Develop and implement standard investigation frameworks and playbooks
• Ensure adherence to global governance and change management processes to support process harmonization

Network Integration & Cross-Site Support

• Act as a site-agnostic process expert, supporting alignment of site activities with network strategy
• Partner with Manufacturing, Process Development, and Quality to bridge development and commercial operations
• Support process harmonization and implementation of best practices across sites

Core Competencies:

• Technical depth & process expertise in late-stage clinical and commercial T cell and viral vector manufacturing
• Leadership without authority across a matrixed, global organization
• Ability to establish business processes, drive standardization and governance in complex environments

• Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy

• Ability to establish business processes, drive standardization and governance in complex environments

Basic Qualificaitons:

• Bachelor's Degree in Engineering, Biotechnology or Life Sciences with the following years of experience in pharmaceutical/biotech manufacturing, process development or process engineering with at least 8 years of relevant experience

OR

• Masters in Engineering, Biotechnology or Life Sciences with the following years of experience in pharmaceutical/biotech manufacturing, process development or process engineering with at least 6 years of relevant experience

Preferred Qualifications:

• Expertise in process equipment and engineering, technology transfer or pharmaceutical manufacturing experience
• Expertise in viral vector manufacturing is a plus
• Cell culture, cell therapy or aseptic processing experience
• Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation

• Experience in Project Management and Project Management Methodology
• Strong understanding of GMP environment and change control processes
• Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)

• Proactive and willing to accept temporary responsibilities outside of initial job description
• Experience in engineering in highly regulated manufacturing environments

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
 

Please apply via the Internal Career Opportunities portal in Workday.