Process expert (m/f/x) DSP

JR Germany; Pfaffenhofen an der Ilm; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the healthcare sector is seeking a Process Expert (m/f/x) DSP in Pfaffenhofen to drive the Downstream Processing workstream. The role involves overseeing project phases, optimizing processes, and ensuring GMP readiness for mammalian cell culture capabilities. Candidates should have a Ph.D. or Master's in Life Sciences and a minimum of 5 years of relevant experience. Fluency in English and German is required.

Qualifikationen

• Minimum 5 years of experience in biotech projects with mammalian cell culture.
• Leadership experience in managing teams within direct and matrix structures.

Aufgaben

• Collaborating with engineering firms for process design and overseeing project phases.
• Drafting and reviewing project documents for accuracy and suitability.
• Optimizing floor planning and process/material flow for manufacturability.

Kenntnisse

Leadership

Problem Solving

Communication

Organizational Abilities

Ausbildung

Ph.D. or Master's in Life Sciences

Tools

MS Office

MS Project

Jobbeschreibung

Job Details

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Posted:

14.05.2025

Expiry Date:

28.06.2025

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Job Description:

Daiichi Sankyo, with over 120 years of experience and approximately 19,000 employees across more than 30 countries, is committed to discovering and delivering innovative healthcare solutions worldwide.

In Europe, our focus areas are:

• Cardiovascular Disease: Protecting people from cardiovascular conditions and supporting patients to enjoy quality life.
• Oncology: Driving innovation in solid tumors and blood cancers, based on breakthrough science from our labs in Japan.

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

For our site in Pfaffenhofen/Ilm, we are seeking highly qualified candidates for the position of:

Process Expert (m/f/x) DSP

Purpose of the Role:

The Process Expert in Downstream Processing (DSP) is a key member of the BioDS project team, responsible for driving the DSP workstream within the project.

The initial focus is on completing activities related to process, qualification, and GMP readiness to establish mammalian cell culture capabilities as part of the BioDS project. Subsequently, the role will focus on clinical trial material (CTM) production and commercial monoclonal antibody (mAb) production in GMP suites.

Key responsibilities include:

• Collaborating with engineering firms responsible for process design, overseeing all project phases from basic design to commissioning, including OQ.
• Drafting and reviewing project documents such as URS, FS, HDS, timelines, and cost estimates for accuracy and suitability.
• Optimizing floor planning, equipment placement, and process/material flow for manufacturability.
• Coordinating closely with DSJ (BTRL Tatebayashi) on process equipment, tech transfer, and knowledge exchange.
• Establishing disciplinary leadership for the downstream team during process transfer and validation phases.

Qualifications:

• Ph.D. or Master's in Life Sciences (e.g., Biology, Biochemistry, Biotechnology, Chemistry, or related fields).
• Minimum 5 years of experience in biotech projects involving mammalian cell culture USP and DSP, preferably with single-use equipment.
• Leadership experience in managing teams within direct and matrix structures.
• Proficiency in MS Office, especially MS Project.

Personal Skills:

• Fluent in English and German.
• High attention to detail with excellent problem-solving skills.
• Strong communication and organizational abilities.