COMPLETE External New Product Development Lead - Tokyo

About the job

The Japan External New Product Development Lead role will act as the key Science Hub interface between the R&D/GH Brand leads, internal development centers, M&S and CDMOs and is responsible for development and delivery of  Japan brand projects covering both OTC and Food Supplements. The role requires a mix of strong communication skills, ability to work and influence across the organization as well as a strong background in product development. For Japan scope projects work with brand leads to prepare project briefs and TPPs. Prepares development strategy for development in the internal development centers or with CDMOs, and is responsible to manage their delivery according to the TPP, Sanofi quality standards, within budget and to the agreed project timelines. Acts as an advisor to global projects where Japan is in scope ensuring Japanese specific requirements are included.

As External New Product Development Lead:

• Key interface for product development between M&S, CDMOs, Growth and Science Hub colleagues
• Drive & lead the development and delivery of development projects that meet the project brief, TPP, on time and in budget
• Act as the technical development advisor for all Japan new product projects and as a Japan expert for global projects for assigned development projects, ensuring all project strategies consider the Japanese market.
• Proposes CDMOs for projects and supervises the end to end CMC development activities at the CDMO.
• Participate in Japan specific ideation workshops providing technical insights and stimulation.
• Provide detailed technical input into the TPP considering Japanese requirements.
• Provide input into development timelines.

• Interface with CHC Development Center network, including Product Research, Technology platform, and TRC. Interface and partnership with Science Hub and M&S.

Main responsibilities:

• Connect and engage with Science Hub and Growth Hub category teams to ideate and co-create the Japanese pipeline for drug projects as the Japanese product development  expert.
• Deliver innovation projects that meet the brief, the TPP, responsible for the development on time and within budget.
• Lead and define technical development strategies for Japan only projects, for CMC,  formulation, analytical and manufacturing process
• Provide guidance on Japan specifics for global projects including CMC technical elements, freedom to operate, organoleptics and ingredients.
• Propose CDMO for each development project to be developed externally and lead and supervise all development activities at the selected CDMO.
• Supervise all project manufacturing activities at Narita M&S site or CDMO for scale-up and transfer and clinical/registration batch manufacture. Support M&S or CDMO during process validation.
• Input into high-quality development technical dossiers to ensure that will be suitable for the Japanese market and regulatory agency.   
• Work on projects of all complexities and at different stage gates.

About you

Education

• Master's degree or Bachelor's degree in Pharmacy, Chemistry or Life Sciences  

Expérience 

• +10 years of relevant experience in Japan Pharma/OTC industries, with relevant experience in formulation development, Innovation process and transfer to industrial sites.
• Track record of working on and delivering products to the Japanese market
• Expert in one CMC discipline i.e. formulation, analytical or process development with a working knowledge of the other disciplines.
• Experience in working with global transversal teams on multiple initiatives.
• Good knowledge of external environment including Japan technology companies and CDMOs

Language :

• Japanese mother tongue language skills, verbal and written.
• Good English communication skills, verbal and written required.

Technical skills :

• Excellent CMC knowledge and a subject matter expert on one of the CMC technical disciplines.
• Good knowledge of Sanofi Innovation process
• Knowledge on Japanese regulatory environment of drug product and non-drug products.
• Skilled on facilitation, situational awareness, continuous improvement, empowerment and increasing transparency.

Soft skills:

• Leadership, Communication skills, problem solving, transverse interaction and proactivity
• Able to work proactively, with little supervision.
• Ability to contribute to complex projects in a transversal environment both internally and externally.
• Good communicator, able to communicate with team members, stakeholders and management.
• Ability to drive new way of working in a complex environment and to challenge the status quo.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.