The Technology Transfer Leader will coordinate and oversee the successful transfer of Insulins manufacturing technologies from the Sanofi Frankfurt Site to the Contract Manufacturing Organization (CMO). This role is responsible for managing the technology transfer process, ensuring the seamless integration of new manufacturing processes into production while adhering to quality and regulatory compliance, as well as project validation, batch, and commercialization timelines.
Main Responsibilities:
- Coordinate and manage the transfer of manufacturing technologies, processes, and analytical methods between the Sending Unit and Receiving Unit (CMO).
- Collaborate with cross-functional teams including production, quality assurance, regulatory affairs, and supply chain to ensure smooth technology transfer.
- Execute technology transfer plans and ensure all aspects are well documented and meet regulatory and quality standards.
- Ensure compliance with Good Manufacturing Practice (GMP), local regulations, and relevant pharmaceutical standards.
- Facilitate training programs for operational staff and stakeholders on new processes, technologies, and equipment.
- Oversee expert knowledge in aseptic processes for sterile injectable products relevant to equipment acquisition, process validation, and cleaning validation.
Skills and Experience:
- Minimum of 3 years’ experience in pharmaceutical manufacturing, specifically in sterile production (e.g., injectable products).
- Proven experience in managing cross-functional teams within a regulated environment.
- Familiarity with product transfer programs and sterile injectable process equipment.
- Strong knowledge of pharmaceutical production processes and GMP requirements.
- Excellent communication skills with the ability to present complex technical information to various stakeholders.
- Proficient in English (Advanced level).
Educational Requirements:
- Degree in Pharmaceutical Engineering, Chemical Engineering, Biotechnology, or a related scientific field.
- At least 3 years’ experience in a similar role in a sterile injectable product manufacturing unit.
Special Conditions:
- Ability to lead and drive cross-functional teams.
- High attention to detail and effective prioritization of multiple tasks in a fast-paced environment.
- Strong troubleshooting and analytical skills.
This position offers robust opportunities for professional growth with an emphasis on collaboration and innovation within a global healthcare company.
