Head (M/F/x) of Bioconjugation Research

vor 1 Woche

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo, Inc. Vollzeit

Head (M/F/x) of Bioconjugation Research

Position:
The Head of 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 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 supporting 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:

- Establishment and management of the newly build bioconjugation process development laboratory 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.
- Supervision of the implementation of the construction project for 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.
- Act within new building project as main technical contact for process related questions 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.

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