6 дней назад
Senior Director, Process Development (Cell Therapy)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Process Development (Cell Therapy) (Biopharmaceutical Manufacturing): Leading site MSAT strategy and commercial cell therapy manufacturing operations with an accent on GMP compliance, technology transfer, process validation, and operational automation. Focus on governing manufacturing support, lifecycle management, data-driven process improvement, regulatory readiness, and cross-functional technical leadership.
Location: Netherlands - Hoofddorp; commercial cell therapy manufacturing facility in Amsterdam
Company
is a biopharmaceutical company developing CAR T-cell and T-cell receptor engineered cancer immunotherapies.
What you will do
- Define and execute the site MSAT strategy, operating plan, budget, workforce model, governance, and performance measures.
- Lead and develop managers and senior technical leaders across the MSAT organization.
- Oversee manufacturing support, investigations, root-cause analysis, CAPAs, laboratory studies, and process improvements.
- Lead technology transfer, lifecycle management, facility fit, comparability, qualification, PPQ readiness, and post-transfer performance.
- Govern validation, process knowledge, statistics, data science, digital capabilities, and operational automation to improve robustness, yield, cycle time, and risk management.
- Represent site priorities in global forums and lead technical readiness for regulatory submissions, inspections, and health-authority commitments.
Requirements
- Degree in relevant science or engineering, or a high school diploma with significant relevant experience.
- Significant leadership experience in a commercial GMP environment.
- Experience in biopharmaceutical manufacturing, technology transfer, or process development.
- Experience leading through managers and senior technical professionals with accountability for technical performance and organizational capability.
- Strong knowledge of GMP requirements, manufacturing operations, technology transfer, process validation, comparability, and process control.
- Experience with cell therapy, biologics, complex aseptic manufacturing, cell culture, single-use systems, or automation is highly relevant.
Nice to have
- Commercial cell therapy manufacturing experience.
- Knowledge of Quality by Design or Six Sigma.
- Strong business and financial acumen with executive-level communication and influencing skills.
Culture & Benefits
- Full-time leadership role within a cancer immunotherapy organization.
- Collaboration across Manufacturing, Quality, Supply Chain, Facilities & Engineering, Product Development, Regulatory Affairs, and global MSAT.
- Focus on inclusive leadership, employee development, accountability, and technical excellence.
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