Process expert (m/f/x) DSP

Daiichi Sankyo; Pfaffenhofen an der Ilm; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the pharmaceutical sector is seeking a Process Expert (m/f/x) in Downstream Processing to join their team in Pfaffenhofen. The role focuses on driving the BioDS project, ensuring GMP readiness, and leading the downstream team. Candidates should have a Ph.D. or Master's in Life Sciences and significant experience in biotech projects. Strong leadership and problem-solving skills are essential. Join us to make a difference in patients' lives.

Qualifikationen

• Minimum 5 years in biotech projects for mammalian cell culture USP and DSP processes.
• Experience in leading and managing teams in direct reporting and matrix structures.

Aufgaben

• Drive the project in the workstream process DSP.
• Ensure timely completion of activities related to GMP readiness.
• Draft and review documents for factual correctness and suitability.

Kenntnisse

Leadership

Problem Solving

Communication

Organizational Skills

Ausbildung

Ph.D. or Master's degree in Life Sciences

Tools

MS Office

MS Project

Jobbeschreibung

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Process expert (m/f/x) DSP

Date: 12 May 2025

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For our site in Pfaffenhofen/Ilm we are seeking highly qualified candidates to fill the position:

Process expert (m/f/x) DSP

Purpose of the function:

The process expert Downstream Processing (DSP) is a key member of the BioDS project team and drives the project in the workstream process DSP.

Initial focus of the role is timely completion of activities (process-related, qualification-related and related to ,,GMP readiness‘‘) to ensure establishment of mammalian cell culture capabilities in course of the BioDS project as committed to Japan. Later, the role is expected to focus on clinical trial material (CTM) production and commercial mAb production in the respective GMP suite(s) in the BioDS building B02.

• The incumbent closely works with the engineering company responsible for the process design and is the direct contact for all project phases from basic design, detail design into construction and commissioning with the OQ being the expected final project phase.
• Essential duties include draft and timely review of documents provided by the engineering contractor such as URS, FS, HDS, timelines, cost estimates,...for factual correctness and suitability for the project. The process expert DSP will also ensure best possible floor planning, equipment positioning, process and material flow for manufacturability. Close cooperation with DSJ (BTRL Tatebayashi) is required to align and drive decisions on process equipment, tech transfer topics as well as knowledge exchange for future projects.
• In addition, it is planned to establish disciplinary leadership for the downstream team as the project moves into process transfer and preparation for IQ / OQ and PQ.

Professional experience & Education:

• Ph.D. or master's degree in Life Sciences (e.g., Biology, Biochemistry, Biotechnology, Chemistry or related field)
• Significant professional experience (minimum 5 years) in biotech projects for mammalian cell culture USP and DSP processes, ideally working directly
• with single-use equipment.
• Leadership Experience: Experience in leading and managing teams in a direct reporting line and also in matrix structures
• Knowledge in MS Office suite, particularly MS Project

Personal skills:

• Fluency in English, German mandatory
• High attention to detail and very good problem-solving skills
• Strong communication and organizational skills

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.