Process Expert

Vor 7 Tagen

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

**Process expert (M/F/x) Process Development Laboratory**:
**Purpose of the function**:
The process expert Process Development Laboratory is a key member of the BioDS project team and drives the project in the workstream Process Characterization Studies (PCS). Purpose is to help establishing the analytical methods, tasks and processes for the Process Characterization Studies of the glycoengineered mAb’s for the future ADC portfolio of Daiichi Sankyo.

**Roles & Responsibilities**:
The incumbent closely works with the colleagues from BTRL in Tatebayashi responsible for the process design and is directly involved in all phases from the laboratory layout finalization to equipment ordering and qualification to planning and performing of PCS studies after successful project completion.
- Joint responsibility for the establishment of a biotechnological laboratory: write safety instructions, SOPs and recipes, order chemicals, support with the installation of novel laboratory equipment
- Support with the qualification and be responsible for laboratory equipment
- Responsibility for the independent establishment and optimization of biotechnological process steps in the upstream and downstream processes:

- Develop and troubleshoot bioprocesses for monoclonal antibodies on a small scale.
- Collaborate with cross-functional teams to optimize processes and ensure quality standards.
- Conduct experiments and analyze data to improve process efficiency and yield.
- Maintain compliance with GMP standards and contribute to the documentation and SOPs.
- Involvement in reporting to and communication with Japanese collaboration team as well as the Analytical Development team (AD) in Pfaffenhofen

**Professional experience & Education**:

- Ph.D. or master's degree in Life Sciences (e.g., Biology, Biochemistry, Biotechnology)
- Experience in bioprocess development, particularly with monoclonal antibodies.
- Experience with analytics of monoclonal antibodies.
- Strong problem-solving skills and the ability to work independently.
- Knowledge of GMP regulations is advantageous.
- Prior experience in setting up Process Characterization Studies (PCS) is advantageous

**Personal skills**:

- Language skills: German (very good spoken and written skills) English (very good spoken and written skills)
- High attention to detail and very good problem-solving skills
- Strong communication with internal teams and external partners, good organizational skills
- Self-reliant and shows initiative, works carefully with a high degree of reliability and sense of responsibility

**Why work with us?**:

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