Teamlead GMP Production Bioconjugation (m/f/x)

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.

For our development and production site in Pfaffenhofen an der Ilm we are seeking highly qualified candidates to fill the position:

Teamlead GMP Production Bioconjugation (m/f/x)

The position:

The Teamlead GMP Production Bioconjugation will be a key contributor to 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.
Your primary role will be to support the establishment of the new production facility as expert from GMP perspective including the necessary workflows and procedures. This also includes the training of the future operational team.
Once the facility is up and running, your task will be to contribute to the management of all operations and maintenance in this GMP bioconjugation facility. Your task will be to ensure compliance with the regulatory requirements and to collaborating with other departments to support manufacturing with good quality.

Roles and responsibilities:

• Contribute to the management of the planning of the new GMP production area for biotechnological active substances, in particular antibody-drug conjugates, with a focus on specific requirements for GMP processes, workflows, and equipment.
• Appropriately manage equipment and regulatory aspects such as segregation and clean room requirements (e.g. zone concept and material flow).
• Support the management of the planning and supervision of the construction project for the GMP production suites (in alignment with the overall construction project).
• Support recruitment and drive training of the future GMP production team.
• Contribute to the preparation and implementation of production and resource planning as well as optimisation and automation of production processes.
• Develop and establish manufacturing instructions in the GMP regulated environment.
• Cooperate with other departments such as Antibody production, Quality Management and Research & Development.
• Responsible for regulatory compliance, policy development and risk assessment.

Professional experience and personal skills:

Education and Experience:

• MSc in Biotechnology, Chemistry, Chemical Engineering, Biotechnology, or a related field; PhD advantageousMaster's degree with extensive relevant experience may also be considered.
• Experience in leading and managing production teams.
• Deep understanding of bioconjugation chemistries and techniques (e.g., antibody-drug conjugates, peptide conjugates) and significant experience in bioconjugation, biopharmaceutical manufacturing, or a related area and proven track record in GMP-regulated environment.
• Knowledge of purification, characterization, and analytical methods for biocompounds and experience of MSAT in New Product Introduction.
• Experience with regulatory inspections and audits.
• Ability to design and optimize manufacturing processes and ability to troubleshoot and resolve technical issues.
• Understanding of quality assurance and quality control strategy.
• Experience with documentation, batch records, and generating SOPs
• Very good knowledge of German and English.

Leadership and Management Skills:

• Ability to lead, mentor, and develop a team of operators and technicians and promote quality culture within the organization.

• Excellent interpersonal and communication skills.

• Experience in managing complex projects, including planning, execution, and delivery within timelines and budgets.

• Ability to prioritize tasks and manage resources effectively.

• Ability to work effectively with global cross-functional teams, including R&D, quality, regulatory, and production departments.

• Independent & goal-oriented working style, organisational skills, and high level of commitment.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.de