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).
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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.

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.