Process Expert (m/f/d) Bioconjugation

Process Expert (m/f/d) Bioconjugation

Company: Daiichi Sankyo Europe GmbH

Location: Pfaffenhofen an der Ilm, Bavaria, Germany

Posting start date: 04/08/2025

Job Description

We are seeking highly qualified candidates for the development and production site in Pfaffenhofen an der Ilm.

The Position

The Process Expert Bioconjugation 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.

Roles And 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 troubleshooting.
• 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.

Personal Skills And Professional Experience

Education and Experience

• PhD or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or a related field.
• GMP/GLP Experience beneficial: experience working in Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) environments.

Technical Skills

• 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.
• Troubleshooting in process flow and performing process validations.

Additional Skills And Attributes

• Excellent interpersonal and communication skills.
• 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 & goal‑oriented working style, organisational skills, and a high level of commitment.
• Very good knowledge of German and English.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Management and Manufacturing

Industries

Pharmaceutical Manufacturing

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