Scientist (m/f/d) GMP ADC Manufacturing

Overview

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

For Our Development And Production Site In Pfaffenhofen An Der Ilm We Are Seeking Highly Qualified Candidates To Fill The Position.

The Position

The Scientist GMP manufacturing ADC will be a key contributor to the establishment of a new drug substance production unit for Antibody-Drug Conjugates (ADC) at the site in Pfaffenhofen.

Your primary role will be to support the establishment of the new production facility as expert from GMP perspective, including the generation of the required GMP documents. Once the facility is up and running, your task will be to contribute to all operations and maintenance in this GMP bioconjugation facility. Your task will include to ensure performance of your tasks in compliance with the regulatory requirements and collaborating with other departments to support manufacturing with good quality.

Roles And Responsibilities

• Contribute to 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.
• Develop and establish manufacturing instructions in the GMP regulated environment.
• Aproperly 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.

Personal Skills And Professional Experience

Education and Experience:

• Bachelor'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 biocompounds.
• 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?

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.