CMC Operational Planning & Capacity Manager

Sanofi•Framingham, MA

9d•Onsite

About The Position

As part of the CMC Operational Planning & Capacity team, the primary role of the CMC OPCM is to customize, plan and track the CMC activities in Research & Development (R&D) and in Manufacture & Supply (M&S) with their timelines and resources reflecting the operational reality and aligned with the overall global project strategy. R&D scope is from Research to Preclinical and Clinical Development, and Product Life Cycle Management post initial market approval. 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.

Requirements

Bachelor's degree, Master's degree, PhD, or MBA in a scientific, technical, or business-related field (e.g., Pharmacy, Engineering — including Chemical, Electrical, or Mechanical —, Biology, Chemistry, Business Administration, or equivalent).
5+ years (Bachelor's), 3+ years (Master's or MBA) OR 2+ years (PhD) of experience in project planning and management and/or CMC operational/laboratory activities within the pharmaceutical, biotechnology, or related regulated industry
Relevant academic/research experience (e.g., co-op, internship, or postdoctoral research in biology or pharmacy-related fields) may count toward the total years of experience when combined with industry experience.

Nice To Haves

Proactive adoption of Digital and/or AI solutions in a work environment
Experience in Biologics and/or Gene Medicine CMC operations
Familiarity with AAV (adeno-associated virus) or LNP (lipid nanoparticle) platforms
Knowledge of planning and project management tools (e.g., Planisware or equivalent)
PMP or CAPM certification
Experience with data visualization tools such as Tableau or Power BI, or advanced Excel skills
Knowledge of finance and budget management

Responsibilities

For each assigned therapeutic project (biologic molecule) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the entered plan and regularly updated in the planning tool (Planisware solution).
The CMC OPCM ensures that the CMC strategy is accurately reflected in terms of project logic with the timelines, including the CMC High Level Plan, and resource workload.
In addition, the CMC OPCM provides workload and capacity analyses and reporting to support the CMC Project Team, and Managers in the CMC Functions if assigned as Function Business Partner.
In particular, he/she develops scenarios to make recommendations on optimization of timelines and of resources, and to support decisions for site re-allocation or outsourcing if there is any bottleneck.
The CMC OPCM also analyses the project deliverable timelines and critical path activities e.g., in support of CMC risk management assessment by the CMC Project Team.
The CMC OPCM is also responsible for ensuring alignment of his/her CMC activities with global strategic project planning and other operational planning from Translational Medicine, Clinical Sciences and Regulatory Affairs, while ensuring proper connectivity and integration of these cross-functional dependencies within the planning tool.
Evolving in an international environment, the CMC OPCM regularly attends CMC Project Team meetings, planning meetings and other related meetings linked to project timelines and resources management (e.g., R&D governance preparation, CMC Function review) and to OPCM business management.