Sr Director, Process Development

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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Kite is seeking a highly accomplished Senior Director, Manufacturing Science & Technology (MSAT), for its commercial cell therapy manufacturing facility in Amsterdam. Reporting to the VP, TCF04 Site Head, this role leads the site MSAT organization and serves on the Site Leadership Team.

As the site’s senior technical authority and process steward, the Senior Director ensures robust, compliant, and reliable commercial operations. The role sets MSAT strategy and leads manufacturing support, technology transfer, lifecycle and validation activities, laboratory operations, process and data science, and operational automation. Success requires deep cell therapy or biologics expertise, strong knowledge of global GMP requirements, and the ability to lead leaders and influence across a matrix network.

• Define and execute the site MSAT strategy, operating plan, budget, workforce model, governance, capabilities, and performance measures in alignment with site and global network priorities.

• Build and develop an inclusive, high-performing organization of managers and senior technical leaders, strengthening succession, technical depth, accountability, and ownership.
• Lead technical governance, escalation, and risk-based decisions for manufacturing support, process performance, validation, and other high-impact issues affecting patients, quality, supply, or compliance.
• Oversee shop-floor support, major and critical investigations, root-cause analysis, CAPAs, laboratory studies, and process improvements.
• Lead technology transfer and lifecycle management, including facility fit, risk assessment, control strategy, comparability, qualification, PPQ readiness, training, and sustained post-transfer performance.
• Govern the validation lifecycle and use process knowledge, statistics, digital capabilities, and data science to improve robustness, yield, cycle time, and proactive risk management.
• Set direction for MSAT laboratories and operational automation, ensuring capable, reliable, validated systems, data integrity, and effective manufacturing integration.
• Lead technical content and readiness for regulatory submissions, health-authority questions, inspections, and commitments.
• Represent site priorities in global forums and partner across Manufacturing, Quality, Supply Chain, Facilities & Engineering, Product Development, Regulatory Affairs, and global MSAT to deliver lifecycle, capacity, cost, reliability, and continuity objectives.
• Sponsor cross-site initiatives that advance operational excellence, technology modernization, and long-term site and network competitiveness.

• PhD/MS degree in relevant Science or Engineering with relevant experience of biopharmaceutical manufacturing, technology transfer or process development OR
• BA/BS degree in relevant Science or Engineering with relevant experience biopharmaceutical manufacturing, technology transfer or process development OR
• High School Diploma with significant experience  of biopharmaceutical manufacturing, technology transfer or process development
• Significant leadership experience in a commercial GMP environment, with demonstrated accountability for technical performance, organizational capability, and delivery through managers and senior technical professionals.

• Technical and operational experience in cell therapy, biologics, or another complex aseptic manufacturing environment; commercial cell therapy experience preferred.

• Proven ability to develop high-performing teams and lead managers and senior technical leaders.
• Deep knowledge of GMP requirements and manufacturing operations, including cell culture, aseptic processing, single-use systems, and automation.
• Strong understanding of technology transfer, process validation, comparability, and process control.
• Excellent prioritization, investigation, and problem-solving skills, with strong business and financial acumen.
• Executive-level communication and influencing skills, including constructive challenge and alignment of diverse stakeholders.
• Knowledge of Quality by Design and/or Six Sigma is a plus.

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.
 

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

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