Scientist (m/f/x) GMP ADC Manufacturing

Job Title: Scientist (m/f/x) GMP ADC Manufacturing

Posting Start Date: 04/08/2025

Job Description:

For our development and production site in Pfaffenhofen an der Ilm we are seeking highly qualified candidates to fill the position:

Scientist (m/f/x) GMP Manufacturing ADC

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 an 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 ensuring 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.
• 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.

Personal skills and professional experience:

Education and Experience:

• 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 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.

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