- Pharmaceutique / Biotechnologique
CMC Project Leader - All Gender
- Éducation : Bac +5 / Master
- Expérience : > 10 ans
Who are they?
At Sanofi, we pursue the miracles of science to improve people’s lives. In France, more than 20,000 passionate men and women tirelessly push their limits to transform the practice of medicine and improve patient health with drugs and vaccines.
The desire to advance science is our strength. We want to improve the health of populations and find new solutions for patients by combining scientific progress and advanced technologies.
In France, we provide more than 400 drugs, vaccines and health products, including 18 vaccines and more than 200 drugs of major therapeutic interest.
Sanofi’s roots are anchored in France where most of the Research and Development is located. In the French medical research landscape, we hold a central role and actively participate in the construction of a dynamic health sector.
To contribute to the world of tomorrow, three commitments guide our actions: access to care for the most vulnerable, inclusion of all through work and preservation of the planet. Nothing would be possible without the remarkable mobilization of our employees and partners.
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.
- The CMC PL is accountable for the CMC (Chemistry Manufacturing Controls) project activities (drug substance, drug product & analytics) of mammalian projects of Sanofi’s R&D pipeline for pre-clinical and early clinical development from pre-candidate selection (PCS) to proof of concept (POC). For this mandate, he/she leads a cross-functional CMC team with functional members/sub-team leaders from R&D CMC including Mammalian & synthetics DS platform, drug product & formulation platform, device development, Bioanalytics, Quality, Regulatory CMC, CMC dossiers, and Demand & Supply representatives in accordance to development phases. He/she has an oversight in CMC and subteams of approximately 30-50 FTEs
- The CMC leader with his/her team in alignment with the CMC functions, creates a strategic and integrated CMC development plan based on global project objectives ensuring alignment with base case and accelerated plans and exploring opportunities for acceleration
- He/she represents the CMC team and functions as core member in the Global Project Team, contributes to overall project strategy and executes the appropriate actions within CMC to achieve project goals. Following the TPP, he/she defines the Quality Target Product Profile (QTPP)
- He/she acts as overall product/process expert for the project and provides technical and scientific expertise on major project topics, drives, and leads technical and scientific discussion and alignment within the CMC team and in cross-functional governance meetings (Technical Review meetings, CMC Boards, RWG, DWG)
- He/she is responsible for quality of CMC contributions to pre-clinical and early clinical phase activities, and CMC elements for regulatory submissions and consultations. He/she assesses together with functions developability/manufacturability
- With the CMC team, he/she drives the evaluation of CMC risks and appropriately escalate to CMC Senior Management (e.g. Cluster Head, Platform Head & Global Management as needed) and Global Project Team (Project Direction) and proactively provides mitigation plans. He/she alerts decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, he/she coordinates corrective measures across functions within R&D in cooperation with local department heads
- He/she is responsible for implementation of CMC deliverables within budget considering external and internal costs. He/she leads and oversees planning of CMC project budget including communication and alignment with global project team and senior management
- Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering, pharmaceutical analysis, biochemistry, chemical engineering, or related discipline with a minimum of 14 years of relevant experience or PhD with minimum of 10 years of relevant experience
- Strong expertise in Biologics CMC and antibody drug conjugates (ADCs) area, with proven experience in at least 1 scientific area, e.g., analytics, process dev., regulatory CMC, manufacturing, etc.
- Strong experience in CMO management and collaboration with external partners
- Comprehensive scientific background in biotechnology and/or protein science
- Experience and understanding of current Pharmaceutical environment including the economic and regulatory challenges
- Experienced in working in cross functional project teams and in complex environment (e.g., transversal assignments across different sites), experience in project management and risk assessment is a plus
- Fluent in English
Behavioural Competencies (LEAD and others)
- Leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders, good communication skills, experience in stakeholder management and networking
- Experience in leading teams
- Ability to work in a matrix organization
- Influencing and negotiation skills to build solutions and partnership
- Objectives and deliverables/results oriented
- Ability to interact effectively with management and experience in interaction with external bodies (e.g., auditors, health authorities, etc.)
- Take responsibility for decisions and accountable for results
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.
As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
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