Project Lead

vor 5 Monaten

Pfaffenhofen an der Ilm, Deutschland Daiichi-Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

**Project Lead (M/F/x) Bioconjugation Development and Production**:
**The position**:
The Project Lead (M/F/x) Bioconjugation will be in charge to lead the establishment of a new drug substance development and production unit for Antibody-Drug Conjugates (ADC). This includes the establishment of a new bioconjugation process development laboratory within an existing building as well as the construction of a GMP bioconjugation area as part of a new biotechnological development and production building at the Pfaffenhofen site.

Beyond planning and management of the construction activities, you will be responsible to lead the build-up of the future associated teams of scientists and operators. After completion of the project, you will take on responsibility as leader of the newly established area. This gives you the opportunity to significantly shape your future area of responsibility with the team.

**Roles and responsibilities**:
Responsibilities for the role encompass the following:

- Management of the planning of the new biotechnological process development laboratory as well as a GMP production area for biotechnological active substances, in particular antibody-drug conjugates, with a focus on specific requirements for processes, premises, equipment, personnel requirements, but also regulatory aspects such as segregation and clean room requirements (e.g. zone concept and material flow)
- Management of the conceptual planning and supervision of the implementation of the construction projects for antibody-drug conjugate research area and the GMP production suites (in alignment with the overall construction project)
- Recruitment, training, and technical management of the future scientific development staff as well as the GMP production team
- Preparation and implementation of production and resource planning as well as optimisation and automation of production processes
- Act in within new building project as main technical contact for the planning and construction of the bioconjugation development and production suites
- Cooperation with other departments such as Antibody production, Quality Management and Research & Development
- Organisation and release of manufacturing instructions in the GMP regulated environment
- Planning, commissioning, and controlling the use of external service providers

**Personal skills and professional experience**:

- MSc in Biotechnology or comparable, with a strong background in process technology; PhD advantageous
- Several years of management experience (team or group) in the field of biotechnological production in a pharmaceutical environment, with previous experience in ADC manufacturing or development is strongly preferred
- Detailed GMP knowledge, especially in biotechnological active ingredient production (ADC)
- Strong knowledge of regulatory requirements and hands-on experience in IND/IMPD submissions as well as associated inspections
- Solid know-how of technical building requirements (HVAC, airlocks, etc.), and handling of high potent API
- Experience in managing global project teams
- Independent & goal-oriented working style, organisational skills, and high level of commitment
- Very good knowledge of German and English

**Why work with us?**:

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