Project Leader CMC, Mammalian Projects Cluster

Sanofi•Framingham, MA

33d

About The Position

Sanofi has an opening for a Project Leader role in our Chemistry Manufacturing & Control (CMC) organization. The CMC Project Leader is accountable for the CMC project activities 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). The key accountability is to lead a cross-functional CMC team with members from R&D CMC including Mammalian DS platform, drug product & formulation platform, device development, Bioanalytics, Quality, Regulatory CMC, CMC dossiers, and Demand & Supply representatives in accordance to development phases. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

PhD, MS, other university degrees in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry).
Minimum of 10 years professional experience, ideally in CMC development, is required.
Leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders.
Good communication skills.
Ability to work in a matrix organization.
Experience in stakeholder management, ability to interact effectively with management and external bodies (e.g., auditors, health authorities, etc.), networking skills.
Influencing and negotiation skills to build solutions and partnership
Objectives and deliverables / results oriented.
Capable to deliver under high pressure.
Take responsibility for decisions and accountable for results
Ability to challenge status quo and to propose alternatives.
Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process development, regulatory CMC, manufacturing, etc.
Comprehensive scientific background in biotechnology and/or protein science.
Experience and understanding of current pharmaceutical environment including the economic and regulatory challenges.
Experience in working in cross-functional project team and in complex environment (e.g., activities across different sites).
Fluent in English.

Nice To Haves

Ideally experience in leading international and/or multi-cultural teams.

Responsibilities

The early-stage CMC Project Leader (CMC PL) is accountable for the CMC project activities of mammalian projects of Sanofi’s R&D Pharma 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 DS platform, drug product & formulation platform, Bioanalytics, device development, quality, regulatory CMC, CMC dossiers, and clinical supply chain as well as M&S representatives in accordance to development phases. He/she has an oversight in CMC and sub-teams 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 R&D/M&S 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 Senior Management (Cluster Head, Platform Head & Global Management as needed) and Global Project Team 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 in cooperation with all relevant site and 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.

Benefits

Bring the miracles of science to life alongside a supportive, future-focused team.
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.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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