22 дня назад
Global Head of Characterization BioAnalytics (Biopharma)
129 040 - 193 560€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Global Head of Characterization BioAnalytics (Biopharma): Leading a global organization responsible for analytical characterization of biologic therapies from CMC development through commercialization and transfer to Manufacturing & Supply with an accent on CQA definition, analytical control strategies, and advanced characterization platforms. Focus on building high-performing teams across sites, harmonizing global operations, supporting regulatory submissions, and transferring high-performance analytical methods.
Location: Frankfurt am Main, Germany
Salary: €129,040–€193,560 per year
Company
is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.
What you will do
- Lead a new global organization of BioAnalytics groups across multiple sites and countries.
- Develop and implement extended characterization strategies for antibodies, nanobodies, multispecifics, and viral and nonviral gene therapy modalities.
- Define critical quality attributes and connect them to analytical and integrated control strategies.
- Manage resources, budgets, forecasting, priorities, and deliverables across a complex biologics pipeline.
- Build teams, develop scientific talent, harmonize processes, and ensure operational and scientific excellence.
- Advance analytical platforms, support CMC dossiers and global submissions, and transfer high-performance analytical methods to Manufacturing & Supply.
Requirements
- At least 15 years of industry experience, including at least 5 years leading an analytical characterization function.
- Extensive experience in extended characterization of large molecules and late-phase development.
- PhD in Analytical Chemistry, Molecular Biology, or an equivalent qualification.
- Strong knowledge of CMC for biological drug development, process and formulation development, Quality by Design principles, and ICH guidelines.
- Experience with global submissions, regulatory agency interactions, analytical project leadership, organizational change, and matrix environments.
- Fluent English required.
Nice to have
- Advanced scientific network in academia and industry.
- Track record of publications and patents.
- Familiarity with digitalization and the evolution of AI in CMC.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion and international career development.
- Rewards package and employee benefits based on contribution and impact.
- Healthcare, prevention, wellness programs, and at least 14 weeks of gender-neutral parental leave.
- Work at the intersection of drug discovery, AI, data, and digital platforms.
- Patient insights are incorporated early into drug development and study design.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →