Scientist (m/f/x) GMP ADC Manufacturing

Overview

Scientist (m/f/x) GMP Manufacturing ADC at Daiichi Sankyo Europe GmbH – Pfaffenhofen site. This role contributes to the establishment of a new drug substance production unit for Antibody-Drug Conjugates (ADC) at the site in Pfaffenhofen. The primary role is to support the establishment of the new production facility as GMP expert, including the generation of the required GMP documents. Once the facility is up and running, you will contribute to all operations and maintenance in this GMP bioconjugation facility, ensuring compliance with regulatory requirements and collaborating with other departments to support manufacturing with high quality.

Roles And Responsibilities

• Contribute to the planning of the new GMP production area for biotechnological active substances, in particular antibody-drug conjugates, focusing on GMP processes, workflows, and equipment.
• Develop and establish manufacturing instructions in the GMP regulated environment.
• Appropriately manage equipment and regulatory aspects such as segregation and clean room requirements (e.g., zone concept and material flow).
• Support the planning of the construction project for the GMP production suites (in alignment with the overall construction project).
• Cooperate with other departments such as Antibody production, Quality Management and Research & Development.

Education, Experience and Qualifications

• Master's degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or a related field.
• Significant experience in bioconjugation or biopharmaceutical manufacturing.
• Proven track record in GMP-regulated environment.

Technical Skills

• Deep understanding of bioconjugation chemistries and techniques (e.g., antibody-drug conjugates, peptide conjugates).
• Knowledge of purification, characterization, and analytical methods for bioconpounds.
• Thorough understanding of GMP regulations and guidelines.
• Experience in the generation of GMP documents.

Additional Skills and Attributes

• Ability to work effectively with global cross-functional teams, including quality, regulatory, and production departments.
• Promote quality culture within the organization.
• Ability to troubleshoot and resolve technical issues.
• Optimization based on CAPA and challenges to new manufacturing technology.
• Independent & goal-oriented working style and high level of commitment.
• Very good knowledge of German and English.

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.

What we offer

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

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing

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