CMC Project Lead

Job Title: CMC Project Lead

Location: Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Global CMC Project Management is a CMC project centric organization leading new product development to deliver innovative medicine for our patients with agility & strategic excellence. Our mission is to lead projects of the Sanofi R&D pharma portfolio from pre-candidate selection to approval.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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.

About You

Education & Experience:

• PhD, MS, other university degrees in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry).

• 10 years professional experience, ideally in CMC development, is required.

Soft skills:

• Leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders

• ideally experience in leading international and/or multi-cultural teams

• 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