Formulation Development Scientist

Formulation Development Scientist

Sanofi

Compiègne, France

ABOUT THE JOB

Drive formulation development process for drug type of project, for new products, switches, line extension and business protection for the main Brands amongst CHC portfolio:

• Support building the development strategy for the projects assigned to Compiegne Development Center, mainly for internal development projects;
• Be based on high level of scientific support to cover high level of regulatory and quality requirements;
• Guide technical work across all project phases;
• Provide information and support needed for budget and milestones definition;
• Keep status update for development projects;
• Interface with CHC Development Center network, including Product Research, Technology platform, and TRC. Interface and partnership with Science Hub and M&S;
• Follow Agile method framework for projects under development, securing Development Center milestones deliveries, right resource allocation and budget tracking.

As Formulation Expert Scientist, the job incumbent is:

• Deliver clear milestones at all project phases;
• At early-stage program: virtual prototypes & mockup testing; Formulation Design & Small size prototyping non GMP; TPP and ideation sessions input;
• At Feasibility stage program: Feasibility Plan definition; Formulation design; API & RM sourcing definition, Cleaning ingredients assessment, Specification assessment, Manufacturing process design, Preliminary stability batches, Formula validation, Feasibility report;
• Responsible to ensure the use of QbD tools: DoE, FMEA, QTPP;
• Product Development strategy: Manufacturing process design; Scale up process ; clinical batches manufacturing, manufacturing of submission batches & ICH Stability; Development report;
• Tech Transfer to the manufacturing site;
• M&S transfer & Launch support.

Main responsibilities:

• Lead and execute formulation development phases;
• Lead pharma status projects, from mid-high complexity, and at different stage gates;
• Ensure the delivery of high-quality development technical dossiers, that will apply for multiple markets and regulatory agencies;
• Build together with Performance group the development plan milestones and project updates on time;
• Connect and engage with Science Hub and Growth Hub category teams to ideate and co-create the pipeline for drug projects. Lead prototyping activities at the DC for pipeline enhancement;
• Scouting of new technologies and new ingredients, as needed;
• Represent Compiègne Development Center at global project teams;
• Seek simplification where needed;
• Ensure HSE and Quality policies are in place at all phases.

ABOUT YOU

Education:

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

Experience:

• +5 years of relevant experience in Pharma industries, with relevant experience in formulation development, Innovation process and transfer to industrial sites;
• Experience in working with transversal teams and with different initiatives.

Language:

• Fluent English communication skills, verbal and written;
• French is a nice-to-have.

Technical skills:

• Relevant experience in formulation development, Innovation process and transfer to industrial sites;
• Knowledge on regulatory environment of drug products, especially OTC;
• Knowledge of Agile methods;
• Skilled on facilitation, situational awareness, continuous improvement, empowerment and increasing transparency.

Soft skills:

• Leadership, Communication skills, problem solving, transverse interaction and proactivity;
• Hands on attitude;
• Ability to drive complex projects in a transverse environment;
• Excellent communicator, able to communicate with external stakeholders and management;
• Ability to drive new Way of Working in a complex environment and to challenge the status quo.

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France      Manufacturing and Logistics      On-site      Pre-clinical Research and Development      Sanofi