Head of New Technology Formulation (m/w/d) Design/Process Development

Purpose of the function

The role is responsible for formulation design and process development across various modalities, with a focus on ADCs, within the Formulation Technology Research Laboratories (FTRL). Responsibilities include supporting the preparation of regulatory submissions (e.g., NDA, BLA, and post-approval changes) as well as manufacturing technology transfer to commercial sites. The role also drives the exploration and evaluation of new technologies within FTRL and serves as an integral contributor to decision-making processes in the Formulation Technology Research Laboratories

Your Responsibilities

• Provide technical and disciplinary leadership for the group.

• Plan, lead, and implement product development projects within the Formulation Technology Research Laboratories (FTRL).

• Establish manufacturing processes, control strategies, and formulation designs.

• Provide technical support for Life Cycle Management (LCM) of commercialized products.

• Lead manufacturing technology transfer activities, primarily to Daiichi Sankyo Europe and CDMOs in the EU, as well as pivotal formulation development.

• Oversee CTM manufacturing activities at Daiichi Sankyo manufacturing sites and/or CDMOs in the EU.

• Support and prepare regulatory submissions for clinical development, NDA, and BLA applications.

• Develop and execute the group's mid-term strategy, annual business plan, and performance review process.

• Manage project progress, operational activities, and resource allocation within the group.

• Drive talent development, foster employee engagement, and support team growth.

• Lead the training and supervision of pharmaceutical interns in accordance with local regulations (Approbationsordnung).

Qualifications

• Ph.D. in Pharmacy, Engineering, Life Sciences, or a related discipline, or a Master's degree with equivalent professional experience.

• Extensive experience (preferably 10+ years) in formulation research, CMC development, or related functions within the pharmaceutical industry, ideally in a global organization.

• Proven expertise in formulation development, product development, and analytical activities.

• In-depth knowledge of global CMC development, particularly formulation research, technology transfer, CMC regulatory requirements, and GMP compliance.

• Demonstrated creativity and, ideally, a strong track record of successful drug development

Skills & Competencies

• Strong leadership and people management skills, with the ability to provide strategic direction, develop talent, and build high-performing, inclusive, and collaborative teams.