Director, Process Engineering - Head of Internal Operations

We will consider candidates in Foster City, El Segundo, Oceanside and Thousand Oaks, CA

·Set the Internal Operations strategy, priorities, governance, and resource plan in alignment with Network MSAT, Process Development and Manufacturing-site needs, and enterprise objective.

·Lead project leaders and technical SMEs by establishing clear accountabilities, decision rights, and escalation pathways.

·Build a capable, inclusive, and accountable team; develop successors and strengthen project leadership, process stewardship, and investigation capabilities.

·Serve as the primary connection between Network MSAT and manufacturing sites, translating site priorities and technical risks into network actions.

·Define and monitor practical measures for portfolio delivery, process-document maturity, investigation effectiveness, risk reduction, and realized business value.

·Advise the Head of Network MSAT and senior stakeholders on operational risk, organizational capability, deploy resources and investments, as required, to deliver near- and long-term objectives, in a scalable manner.

·Provide leadership during high-impact manufacturing events, risks, regulatory challenges, and technical investigations; with clear executive communication.

·Accountable for leading a focused portfolio of highly-complex, cross-site MSAT projects with clear outcomes, milestones, resources, risks, and governance.

·Partner with cGML and Process Design to reflect lessons learned and improvements made to our commercial operations, which has strengthened process robustness, operational readiness, and cost effectiveness.

·Integrate project execution with validation, regulatory, supply, and site implementation plans to support predictable delivery.

·Own the governance and lifecycle of standardized global process documentation, including enhanced Process Description Reports (ePDRs).

·Lead global MSAT impact assessments for change controls and lifecycle changes to maintain cross-site consistency and reduce process drift.

·Expand process stewardship to pFMEAs, control strategy linkages, reusable technical knowledge, and effective handoffs into routine operations.

·Lead complex cross-site investigations involving process performance, critical quality attributes, comparability, assay variability, and recurring manufacturing issues.

·Establish a consistent global investigation framework, including trigger and escalation criteria, a practical playbook, analytical tools, and lessons learned.

·Ensure investigation conclusions are scientifically sound and translated into sustainable process improvements or lifecycle actions.

·Bachelor's degree in chemical engineering, biochemical engineering, biotechnology, biochemistry, biology, chemistry, or a related scientific/engineering discipline with 12+ years of relevant experience; OR a Master's degree with 10+ years of relevant experience; OR a PhD with 8+ years of relevant experience.

·Significant people-leadership experience, including leading multidisciplinary technical teams in a regulated biopharmaceutical manufacturing environment.

·Demonstrated experience leading complex, cross-functional programs across multiple sites or business units, including strategy, governance, prioritization, resource planning, risk management, and delivery through others.

·Demonstrated leadership of global or cross-site investigations involving process performance trends, critical quality attributes, comparability, assay or method variability, and product-impact assessment.

·Demonstrated experience supporting cGMP manufacturing, process lifecycle management, technical investigations, change impact assessment, CAPA, and inspection readiness.

·Proven ability to navigate ambiguity, apply systems thinking, influence senior stakeholders without direct authority, and translate technical risks into clear business decisions.

·Excellent written and verbal communication skills, including the ability to communicate with senior leaders and represent the organization in high-stakes technical and operational forums.

·Strong relationship-building and influencing skills, with the ability to align senior stakeholders and lead effectively without direct authority.

·Clear, concise, and audience-appropriate communication skills, including the ability to translate complex technical topics into business decisions.

·High learning agility, sound judgment, and comfort operating through ambiguity, changing priorities, and incomplete information.

·Demonstrated emotional intelligence, active listening, constructive challenge, and conflict-resolution skills.

·Strong organizational and prioritization skills, with the ability to balance urgent operational needs and longer-term capability development.

·Direct experience across MSAT, Manufacturing, Quality, Lifecycle Management, Technology Transfer, and/or Process Development.

·Experience in cell therapy, gene therapy, viral vector, biologics, aseptic processing, or other complex biotechnology manufacturing platforms.

·Experience leading technology transfers, new product introductions, validation/PPQ, comparability, continued process verification, and post-approval lifecycle changes.

·Working knowledge of Lean, Operational Excellence, DMAIC, statistical process control, Quality by Design, FMEA, and structured root cause analysis.

·Experience using data, analytics, automation, or digital tools to improve portfolio decisions, technical investigations, process monitoring, and knowledge management.

·Proven success developing technical experts, establishing new organizational capabilities, and leading transformation while sustaining near-term business delivery.

The salary range for this position is:

Kite 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:

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.