Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

Early development CMC synthetics platform in Vitry is seeking an experienced and motivated scientist with leadership qualities, capable of coordinating multiple activities, to support the development of new therapeutics through preclinic up to proof of concept in human.

If you are the One, Come and Join Us.

MISSION

Within CMC-SYNTHETICS - Early Development Department

• Determine the formulation strategy and process for the execution of each drug development project for early clinical phases in collaboration with the internal teams and the external partners CROs/CMOs
• Represent the formulation team for early clinical phase drug development within CMC project teams and contribute to the development of overall strategies, providing regular updates of operational activities, timelines, and budget
• Apply/Ensure the implementation of 'Good Manufacturing Practices' (GMP) and associated documentation at all stages of formulation / drug product development for clinical studies
• Monitor and track the formulation operations carried out by CMOs/CROS within approved timelines and milestones, and ensure the compliance with defined objectives and deliverables
• Coordinate the writing of technical documentation (with appropriate alignment between functions and CMOs/CROs) and archive the approved versions of the documents
• Review the Technical conditions documents, manufacturing instructions, and executed manufacturing batch records
• Approve documentation related to pharmaceutical manufacturing operations provided by CROs/CMOs and archive appropriate GMP documentation
• Initiate and coordinate the quality actions related to pharmaceutical manufacturing operations (deviations, CAPA, change control)
• Apply for French import licenses for investigational drugs for human use
• Follow the logistics flows of bulk pharmaceutical products manufactured by CROs/CMOs
• Identify the bottlenecks, highlight the issues with CMOs/marketing team and proactively pursue their resolution with contingency planning efforts and ad-hoc cross-functional working groups, as required
• Provide accurate forecasting, tracking and budget adherence for projects
• Consolidate and follow the transition phases of projects from the early clinical phases to the later stages of clinical development
• Interface with the internal partners: site quality operations, purchasing, finance, external partnerships, global CMC Project Management, Supply chain and also interface with CROs/CMOs
• Participate in the implementation of the accelerated development approach for First-in-Human/Phase-1 studies

REQUIRED PROFILE

Qualification

• Bac+5/8, Engineer, Pharmacist, Ph.D., or equivalent

Experience

• Experience (of at least 10 years) in one of the fields of CMC and particularly in Formulation Development (pre-clinical and early clinical phases - 1 & 2a/PoC in human)
• Experience in cross functional management of teams in complex international and multi-cultural environment

Technical Skills & Specific Knowledge

• Knowledge of Good Manufacturing Practices (GMP)
• Solid knowledge in pharmaceutical development
• Project management skills

Strong communication skills to

• Manage international relationships and communication exchanges (lead meetings) internally and with CROs/CMOs/Third parties in English language
• Good written and verbal communication skills
• Perseverance, listening skills

Behavioral skills

• Reactivity, agility and flexibility in the face of a very dynamic early drug development portfolio with autonomy and sense of organization
• Functioning efficiently in a rapidly changing environment and adhering to company values, principles, and mission
• Desire to solve complex problems
• Ability to efficiently manage demanding and stressful situations
• Respect of defined deadlines and priorities
• Proficiency in self-learning new skills, tools, and software

Languages

• French and English: Read, speak, write

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.