Bioconjugation Process Development Specialist

vor 3 Wochen


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

About Daiichi Sankyo Europe GmbH

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Daiichi Sankyo is a leading global pharma innovator with over 120 years of experience. We have more than 17,000 employees in over 20 countries worldwide.

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We are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are located in Munich, Germany, and we have affiliates in 13 European countries and Canada.

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Job Opportunity

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We are seeking a highly qualified Process Expert Bioconjugation (m/f/x) to fill the position at our development and production site in Pfaffenhofen an der Ilm.

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The successful candidate will contribute to the establishment of a new drug substance development and production unit for Antibody-Drug Conjugates (ADC). This role will support the establishment of a new bioconjugation process development laboratory and, once the laboratory is operational, perform process transfer activities to the site in Pfaffenhofen.

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  • Main Responsibilities:
  • Support the planning of the new biotechnological process development laboratory for biotechnological active substances, in particular antibody-drug conjugates, 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 trouble shooting
  • Perform technical transfer activities to GMP manufacturing suite, including process development and analytical tasks
  • Closely collaborate and communicate with relevant stakeholders, in particular the process development lab in Japan, to implement and advance development projects in the new laboratory (once established)
  • Perform PCS studies for regulatory submissions
  • Support development project as Subject Matter Expert concerning scientific and regulatory aspects
  • Cooperate with scientists and experts from other departments and research groups within the global organization
  • Lab maintenance, incl. analytical equipment such as HPLCs
  • Material (raw materials, consumables and waste) logistics
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Requirements

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To be successful in this role, you should possess a PhD or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or a related field. GMP/GLP Experience is beneficial.

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Additionally, you should have knowledge of bioconjugation techniques and chemistries, 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, and troubleshooting in process flow and performing process validations.

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Benefits

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We offer excellent benefits, including work-life balance, growth and development opportunities, health and wellbeing support, and a competitive salary range of €80,000 - €110,000 per year, depending on your qualifications and experience.

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Our ideal candidate is an independent and goal-oriented individual with excellent interpersonal and communication skills, ability to drive innovation in bioconjugation techniques and manufacturing processes, commitment to continuous improvement in laboratory practices and procedures, and ability to work effectively with global cross-functional teams.

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Please note that we require very good knowledge of German and English.



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