\n Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries.

For our offices in Pfaffenhofen an der Ilm and/or Munich we are seeking highly qualified candidates to fill the position:

Manager (m/f/x) Manufacturing Services (Biocompounds)

The pilot manufacturing services lead oversees and supports in technical coordination of the operations in BioCompounds Development, ensuring a seamless operational environment and allowing development staff to focus on scientific and operational activities.

Roles and responsibilities:

The incumbent closely works with both plasmid group, enzyme group, the bioanalytical & research lead and the scientific advisor.
Essential duties include

• Leading the team of 1 \xe2\x80\x93 3 employees
• Responsible for the creation of the process orders in the SAP-system, manufacturing of the process orders on schedule and purchase in case of shortages of resources
• Project-independent production support
• Assurance of appropriate documentation of manufacturing steps
• Support in execution of the batch record review, checking that the processes were operated within the defined ranges and that the acceptance criteria for the IPC-results are met, regular logbook review
• Assurance that the equipment and facilities remain in a cleaned, maintained, and ready-to-use state
• Contribution for the preparation of SOPs for operating procedures, hygiene, cleaning, EHS and assurance that the SOPs are followed by the personnel/colleagues
• Contribution to implement and maintain smooth, cost efficient and quality assuring procedures
• Execution of validation tests for manufacturing and cleaning processes and qualification tests for equipment
• Participation in projects, collaboration with quality control, quality assurance, engineering and other departments
• Contribution for the preparation of EHS risk assessments
• Pilot plant Training of the personnel/colleagues

• Leadership experience and people management (target setting and feedback, management of conflicts as well as development and retention planning)
• Engineering degree in biotech or any related technical field or significant experience (>5 years) in a biotechnological production environment
• Experience in project management and coordination of external engineering companies
• IT-skills, in particular SAP and MS Office suite
• Leading and motivation of co-workers
• Assurance that GMP- and EHS-requirements are followed
• Fluency in English, German mandatory
• High attention to detail, well-structured working style and very good problem-solving skills
• Strong communication and organizational skills, good prioritization
• Reliability, flexibility, and precision
• Quality orientation
• Good technical knowledge

• Excellent Benefits
• Work-Life Balance
• Growth and Development
• Health and Wellbeing Support

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