обновлено 5 дней назад
Associate Director, Technology Transfer (Aseptic Fill & Finish)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Technology Transfer (Aseptic Fill & Finish): Leading end-to-end commercial drug product transfers from process scale-up and PPQ through regulatory filing, inspection readiness, and first launch with an accent on aseptic fill & finish manufacturing. Focus on implementing processes at GMP sites, resolving complex technical challenges, managing change controls and deviations, and coordinating cross-site manufacturing strategies.
Location: Stein, AG, Switzerland; fully site-based. Relocation assistance is available for eligible candidates and their families.
Company
is a global life sciences and contract development and manufacturing organization with more than 30 sites across five continents.
What you will do
- Lead complex commercial drug product technology transfers from new product introduction through process qualification, regulatory filing, inspections, and first commercial launch.
- Act as the global subject matter expert for process technology transfer and define technical strategies across sites and product lifecycles.
- Lead process setup, scale-up, implementation, and on-site technical support at GMP drug product manufacturing sites.
- Own process implementation, control strategies, validation documentation, and review of regulatory filing dossier modules.
- Drive GMP change management, change controls, product and process deviation resolution, and CAPA implementation.
- Serve as the technical authority and primary manufacturing contact for internal and customer project teams.
Requirements
- Industry expertise in biotech, pharmaceutical, or CDMO environments, with strong drug product development and technology transfer experience.
- Experience with aseptic fill and finish processes, such as lyophilization and prefilled syringes.
- Deep knowledge of GMP, regulatory, and CMC requirements, with experience translating strategy into manufacturing execution.
- Ability to lead complex cross-site manufacturing strategies, resolve high-impact technical challenges, and influence senior stakeholders.
- University degree in Biochemistry, Pharmaceutical Science, or a related field; PhD preferred.
- Fluent English required; German is a plus.
Culture & Benefits
- Agile career environment and dynamic work culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-oriented compensation programs and competitive salary.
- Lifestyle, family, and leisure benefits.
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