Senior Manager Formulation Technology

Senior Manager Formulation Technology

Daiichi Sankyo Europe

Pfaffenhofen an der Ilm, Germany

Purpose of the function:

The holder of the position “Senior Manager Formulation Technology (m/f/x)” is responsible for the planning and organization of formulation and process development of various modalities - with a focus on parenteral formulation containing nanoparticular systems (e.g. LNPs). The position also includes scientific and hands-on support of the members in the operational group, as well as scouting and establishing new manufacturing technologies. Cooperation with external partners and close collaboration within international teams are an essential part of this position.

Key responsibilities:

• Independent planning and evaluation of experiments for formulation and process development of various modalities;
• Independent planning and evaluation of physical and chemical properties of liquid and lyophilized products;
• Scientific and hands-on support of the operational team members;
• Writing scientific reports and support of the generation of regulatory documents;
• Scouting and evaluation of new manufacturing technologies and collaboration with external partners;
• Preparation and technical support of technical transfers;
• Collaboration in international, multi-disciplinary project teams (incl. colleagues from Japan, US, and CMOs);
• Support of the expansion and life cycle management of the lab and equipment;
• Writing and approval of SOPs and manufacturing documents;
• Support of general lab operations.

Personal skills and professional experience:

• Ph.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master’s degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences;
• Several years of experience in international pharmaceutical/biotechnology industry, especially in the field of lyophilization and nanoparticular systems (e.g. LNPs);
• Experience in working with CMOs preferred;
• Excellent communication skills, team work and intercultural competence;
• Good knowledge of DoE;
• Good knowledge of the regulatory requirements;
• German language would be preferred.

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