Project Leader CMC, Mammalian Projects Cluster

Job title
:
Project Leader CMC, Mammalian Projects Cluster

• Location:
  
  Framingham, MA

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.

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.

• 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 develop ability/manufacturability.
• With the CMC team, he/she drives the evaluation of CMC risks and appropriately escalates 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.

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.

• Leaders…