Sr Director, Process Development

2310 Kite Pharma EU B.V.; Hoofddorp; In loco; EUR 210.000 - 260.000; Tempo pieno

Descrizione del lavoro

Kite Pharma EU B.V. in Amsterdam seeks a Senior Director, Manufacturing Science & Technology (MSAT) to lead the site MSAT organization for commercial cell therapy manufacturing. Reporting to the Site Head, you will set MSAT strategy, lead manufacturing support, technology transfer, lifecycle and validation activities, and ensure robust, compliant operations.

The role requires deep cell therapy or biologics expertise, strong GMP knowledge, and the ability to lead leaders across a matrix network.

Competenze

• PhD/MS in relevant Science or Engineering with biopharmaceutical manufacturing/technology transfer experience.
• BA/BS in relevant field with biopharmaceutical manufacturing experience.
• High School Diploma with substantial biopharma manufacturing experience.

Mansioni

• Define and execute site MSAT strategy, budget, workforce model, governance, and performance metrics.
• Build and develop an inclusive, high-performing organization of managers and senior leaders.
• Lead governance, escalation, and risk decisions for manufacturing support and validation.
• Oversee investigations, CAPAs, laboratory studies, and process improvements.
• Lead technology transfer, lifecycle management, qualification, and post-transfer performance.
• Govern validation lifecycle, leverage data science and digital capabilities to improve metrics.
• Set direction for MSAT labs and automation, ensuring data integrity and integration.
• Prepare regulatory content and respond to agency questions and inspections.
• Represent site priorities in global forums and drive cross-site initiatives.

Conoscenze

MSAT leadership

GMP knowledge

Technology transfer

Lifecycle management

Process development

Data science

Operational automation

Regulatory readiness

Executive communication

Cross-functional leadership

Formazione

PhD/MS in relevant Science or Engineering

BA/BS in relevant Science or Engineering

High School Diploma with relevant experience

Descrizione del lavoro

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. 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 Kite and help create more tomorrows.

Job Description At Kite, we are united by one goal: curing cancer. Join us in connecting that purpose to our work every day. 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.

Key Responsibilities

• 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.

Basic Requirements

• PhD/MS degree in relevant Science or Engineering with relevant experience of biopharmaceutical manufacturing, technology transfer or process development
• BA/BS degree in relevant Science or Engineering with relevant experience biopharmaceutical manufacturing, technology transfer or process development
• 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.

Preferred Qualifications

• 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.

Equal Employment Opportunity (EEO)

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.

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.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.