Daiichi Sankyo Europe GmbH | Germany | 85xxx Pfaffenhofen an der Ilm | Permanent position | Full time | Published since: 17.04.2026 on stepstone.de
Head of Fill & Finish (m/f/d)
At Daiichi Sankyo we are united behind a single goal: to improve life around the world through innovative medicines. With active innovation since 1899, presence in more than 30 countries and over 19,000 employees, we develop groundbreaking therapies in oncology, cardiovascular diseases, rare diseases and immune diseases. In line with our vision 2030, "to be an innovative global healthcare company that contributes to the sustainable development of society," we create a healthier, hopeful future for patients, their families and society. Our European headquarters is located in Munich, Germany, and we have offices in 15 European countries and Canada. From now on we are looking for a dedicated/n for our location in Pfaffenhofen Head (m/w/d) of Fill & Finish 5 Position: Daiichi-Sankyo invests in a state-of-the-art production unit for aseptic filling and lyophilization of high-potent drugs. To strengthen our team we are looking for a future department manager with many years of experience in Fill&Finish including. Lyophilization. You should have fun taking on a leading role in the planning, organisational building and commissioning of the area. After completion of the project, you take responsibility as department manager for the newly built area. This allows you to significantly shape your future area of responsibility with the team. .
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Your tasks • Your profile • What we offer
During the projecting phase: Close cooperation with the project manager, the project team and external service providers Cooperation in the planning/design of clean rooms and production facilities, taking into account the requirements relating to: GMP, reliability, capacity, EHS, GMP and material and personnel flows Compilation of Qualification Documents (PQ), SOPs, Manufacturing Protocols, Risk Analysis, Hygiene and Documentation Concepts together with the team and, if applicable, external service providers Development of production concepts and processes Planning the start-up and preparation of the required documents together with the project team for the Fill & Finish area Creation of training concepts and documents and their implementation Conscientious development of the production team Close cooperation with the existing production departments After commissioning: Line of production unit with several teams (layer system) Budget (investments / personnel) and cost planning as well as organizational concepts Implementation of the production plan in line with the deadline for production planning Ensuring compliance with EHS requirements Ensuring GMP and approval-compliant production and documentation Ensuring the implementation of employee training Examination and assessment of deviations and complaints Working with production transfers, qualifications and validations Continuous improvement and standardization of manufacturing processes under economic, technological, GMP and EHS points of view Representation of inspections by national and international authorities and customers and self-inspections Ensuring the smooth internal operation through the information and motivation of the employees and delegation of tasks and responsibilities to the production team
Complete university degree (pharmacist), pharmacist or comparable qualification, ideally with completed doctoral degree At least 10 years of production experience in the aseptic filling and as much as possible lyophilization of medicinal products, ideally also with insulator technology and high-potential pharmaceuticals, and CIP/SIP systems At least 5 years of leadership experience in the GMP-regulated environment Knowledge of legal regulations (national and international) Deep understanding of regulatory requirements (EU-GMP incl. Annex 1, FDA regulations etc.) including long-term audit and inspection experience including US-FDA Very good German and English skills in word and writing High sense of responsibility, hands-on mentality, good team skills and ability to motivation the employees Exact mode of operation and flexibility Impressed communication and decision-making skills and structured and solution-oriented working methods
Attractive Benefits Work-life balance Personal growth and development Health and well-being
Location
 | Daiichi Sankyo Europe GmbH | |
| 85276 Pfaffenhofen an der Ilm | ||
| Germany |
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