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

Daiichi Sankyo Europe GmbH; Pfaffenhofen an der Ilm; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Inclusive and diverse work culture

Opportunities for continuous learning

Zusammenfassung

Daiichi Sankyo Europe GmbH in Pfaffenhofen an der Ilm is seeking a qualified individual to lead formulation design and process development. The role involves supporting regulatory submissions, implementing product development projects, and overseeing CTM manufacturing activities.

The ideal candidate holds a Ph.D. with extensive experience in formulation research and leadership skills. You will foster continuous learning in an inclusive environment while contributing to our mission of improving patients' lives.

Qualifikationen

• 10+ years of experience in formulation research or related functions.
• Experience in global organizations with drug development.
• Strong understanding of CMC regulatory requirements.

Aufgaben

• Lead product development projects within FTRL.
• Support regulatory submissions for clinical development and BLA.
• Train pharmaceutical interns according to local regulations.

Kenntnisse

Leadership skills

Communication skills

Problem-solving skills

Analytical skills

English proficiency

Ausbildung

Ph.D. in Pharmacy, Engineering, Life Sciences, or related discipline

Master's degree with equivalent professional experience

Jobbeschreibung

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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.
• Demonstrated success in supporting and/or leading BLA submissions.
• Previous experience in a line management role.
• Excellent communication, presentation, and negotiation skills, with the ability to influence stakeholders, build consensus, and manage conflicts across all organizational levels.
• Proven ability to work effectively in global matrix organizations and to lead cross‑functional, multi‑regional, and multicultural teams.
• Strong analytical, organizational, and problem‑solving skills, with the ability to develop and oversee long‑ and mid‑term formulation strategies and ensure effective resource planning.
• Business‑level proficiency in written and spoken English.

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.