Sanofi · 2 weeks ago
Project Leader CMC, Mammalian Projects Cluster
Framingham, MA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expSanofi 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.
Health CareLife SciencePharmaceuticalTherapeutics
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
Qualification
Required
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
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
Preferred
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 status quo and to propose alternatives
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
BioWorld Financial Watch
2026-02-04
Company data provided by crunchbase