Job Description
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:
Senior GMP Production Manager (m/f/x) Bioconjugation
The position:
The Senior GMP Production Manager 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. You task will be to ensure compliance with the regulatory requirements and to collaborating with other departments to support manufacturing with good quality.
- 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
Education and Experience:
- Ph.D. in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or a related field
- Master's degree with extensive and relevant experience may also be considered
- Leadership Experience: Proven track record in leading and managing scientific teams in a laboratory setting
- GMP/GLP Experience: Experience working in Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) environments
Technical Skills:
- In-depth knowledge of bioconjugation techniques and chemistries (e.g., antibody-drug conjugates, peptide conjugates)
- Proficiency in analytical methods for characterization and quality control of bioconjugates
- Experience in the development, optimization, and scale-up of bioconjugation processes
- Familiarity with purification and analytical techniques related to bioconjugates
- Understanding of regulatory requirements and guidelines pertinent to bioconjugate production
Leadership and Management Skills:
- Ability to lead, mentor, and develop a team of scientists and technicians
- 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
- Trouble shooting in process flow and perform process validations
- Responsible for regulatory compliance, policy development and risk assessment
- Understanding of quality assurance and quality control strategy
- Data acquisition to support manufacturing and regulatory submission
Additional Skills and Attributes:
- Ability to drive innovation in bioconjugation techniques and manufacturing processes
- Commitment to continuous improvement in laboratory practices and procedures
- 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
- Very good knowledge of German and English
- Excellent benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support