Job Title:  Manager Manufacturing Support Bioconjugation BioDS (m/w/d)

Job Requisition ID:  1906

Posting Start Date:  7/30/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

The position:

We are immediately seeking a dedicated individual for our location in Pfaffenhofen.

Manager Manufacturing Support Bioconjugation BioDS (m/w/d)

Details of the activity:

During the planning phase:

• Active participation in the establishment of a new GMP production area for biotechnological active ingredients with a focus on antibody-drug conjugates (ADCs) and single-use technology.
• Development and design of GMP concepts (e.g., zoning concepts, material and personnel flows, hygiene concepts)
• Creation, review and implementation of SOPs, manufacturing instructions, risk analyses and GMP documentation
• Close collaboration with project management, QA, engineering, as well as external partners and suppliers
• Support during the commissioning of systems, premises and production processes in a GMP environment
• Participation in qualification and validation activities (e.g. PQ, cleaning and process validation)
• Development and implementation of a training system

Operational phase (after commissioning)

• Close support/collaboration in the operational GMP environment with a clear presence on the shop floor
• Creation, maintenance and continuous improvement of manufacturing documents and SOPs
• Planning and conducting training courses as well as direct instruction of employees in the production environment
• Ensuring GMP-compliant processes and continuous improvement of processes and standards
• Handling of deviations including root cause analysis and implementation of effective CAPA measures
• Creation and management of change control procedures 
• ; performance of risk analyses (GMP and EHS)
• Preparation and active support of inspections and audits
• Taking on roles such as hygiene officer for the production area
• Close collaboration with QA, QC, EHS, development and engineering

Professional and personal requirements:

• Completed studies in pharmacy, biotechnology, biochemistry, chemistry or a comparable field. 
• At least 3 years of experience in biopharmaceutical manufacturing, ideally in the field of bioconjugation or DSP.
• Practical experience with single-use technologies is an advantage.
• Sound knowledge of GMP regulations (EU-GMP, ideally also international) 
• Experience in creating and implementing GMP documentation
• A basic understanding of bioconjugation processes (e.g., ADC) as well as their production and analysis is advantageous. 
• Structured, independent and solution-oriented work style
• Strong hands-on mentality and high presence in the production environment
• Ability to provide practical guidance and support to employees
• Excellent communication and teamwork skills, also in interdisciplinary teams 
• Organizational strength and implementation orientation
• Very good German and English skills