Formulation Project Manager
Compiegne
About the job
At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately,challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing "Health in Your Hands".
Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the "Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World".
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We strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.
To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.
The formulation scientist manager is a member of Compiegne Global Development Center, part of the Global CHC Science Hub.
In Compiegne Development Center we create oral products for global and local brands, through a fusion of internal and external technologies, that stand out in the market, and meet the diverse needs of our consumers. We foster a culture of collaboration, working closely with our internal stakeholders and tapping into a rich network of CDMOs.
Main responsibilities
- Lead and actively participate on the formulation and process development of CHC products (new products, line extensions, business protection as needed) in line with regulatory requirements according to the region/country and group's quality policies.
- Management of a team of 3 to 4 galenic technicians.
- Guarantee the right level of technical competence required for the team, by promoting internal discussions and by promoting technical training for team members.
- Ensure the delivery of high-quality technical development files, which will apply to multiple markets and different regulatory agencies eg EU, US, JP.
- Build the development plan milestones with the Performance group and ensure the project is monitored on time.
- Co-create the TPP (Target Product Profile) with the global project team.
- Provide clear milestones and deliverables across all phases of a project:
- Early stage (ideation phase): virtual prototypes and mock tests; formulation design and non-GMP small-scale prototyping; participation in TPP and ideation sessions
- Feasibility phase (feasibility phase): definition of the feasibility plan; Design of formulas; process, API and RM procurement plan, taking into account the regulations and the group's restrictive ingredient list, evaluation of specifications, preliminary stability batches, validation of the formula, feasibility report.
- Participates in the implementation of QbD tools: DoE, FMEA, QTPP.
- Development phase (Product development strategy): scale-up of the manufacturing process; manufacture of clinical batches, manufacture of submission batches & ICH Stability; Development report
- Transfer of technology to the manufacturing site
- Support for process validation and launch
- Early stage (ideation phase): virtual prototypes and mock tests; formulation design and non-GMP small-scale prototyping; participation in TPP and ideation sessions
- External Development Management - CDMO Technical Contact
- Prospecting new galenic forms and new technologies
- Seek simplification where necessary.
- Ensure HSE and Quality policies are in place at all project phases.
About you
- A minimum +5 years experience in pharmaceutical industry in development, management experience is a plus.
- The ability to manage multiple projects in a cross-functional and multi-cultural organization, problem solving orientation. Ability to communicate in complex environments, Leadership, and assertiveness skills.
- Skills in formulation and process development of oral dosage forms, knowledge of the regulatory environment of pharmaceutical products, technical transfer to industrial sites.
- A Master or equivalent in Science/Pharmacy or Engineering.
- Proficiency in French AND English, both spoken and written.
Why choose us?
We are excited about external stakeholder engagements and how we can bring the science behind our products to life, how we can put health in the hands of our consumers. With our agile mindset, we are unstoppable to make it simple and clear. If you enjoy working in an agile, creative, cross-functional, multinational team, this is the place to be.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.