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Senior Process Manager

vor 2 Monaten


Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit
About Daiichi Sankyo Europe GmbH

Daiichi Sankyo Europe GmbH is a leading pharmaceutical company with over 120 years of experience and a global presence in over 20 countries. Our company is dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.

About the Role

We are seeking a highly qualified Senior Process Manager - Bioconjugation Expert to join our team in Munich, Germany. As a key contributor to the establishment of a new drug substance development and production unit for Antibody-Drug Conjugates (ADC), you will play a crucial role in the development and implementation of bioconjugation processes.

Key Responsibilities
  • Support the management of the planning and establishment of a new biotechnological process development laboratory and GMP production area for biotechnological active substances, with a focus on specific requirements for processes and equipment, including regulatory aspects.
  • Contribute to the local build-up of scientific and technical know-how on bioconjugation process development, characterization, and troubleshooting.
  • Support recruitment and drive training of the future laboratory staff (scientists and technicians).
  • Lead technical transfer to GMP manufacturing suite.
  • Drive local process development as part of a global organization.
  • Closely collaborate and communicate with all relevant stakeholders to implement and advance development projects in the new laboratory.
  • Support development projects as Subject Matter Expert concerning scientific and regulatory aspects.
  • Cooperate with scientists and experts from other departments and research groups within the global organization.
Requirements
  • 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 and goal-oriented working style, organizational skills, and high level of commitment.
  • Very good knowledge of German and English.