Project Leader CMC, Mammalian Projects Cluster
Eacademy Sanofi, Framingham, MA, United States
Job Title
Project Leader CMC, Mammalian Projects Cluster
Location
Framingham, MA
About the Job
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.
Main responsibilities
The early‑stage CMC Project Leader 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 PCS to POC.
Lead 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. Oversight of approximately 30‑50 FTEs.
With the CMC team, create 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.
Represent the CMC team as a core member in the Global Project Team, contribute to overall project strategy and execute the appropriate actions within CMC to achieve project goals. Following the TPP, define the Quality Target Product Profile (QTPP).
Act as overall product/process expert for the project, provide technical and scientific expertise on major project topics, drive and lead 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…).
Responsible for quality of CMC contributions to pre‑clinical and early clinical phase activities, and CMC elements for regulatory submissions and consultations. Assess developability/manufacturability together with functions.
Drive evaluation of CMC risks with the team and appropriately escale to Senior Management and Global Project Team, provide mitigation plans, alert decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, coordinate corrective measures across functions in cooperation with all relevant site and department heads.
Responsible for implementation of CMC deliverables within budget, lead and oversee planning of CMC project budget including communication and alignment with global project team and senior management.
About You
Education & Experience
PhD, MS, or other university degrees in biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry). Minimum of 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.
Experience 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), 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 propose alternatives.
Technical skills
Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process development, regulatory CMC, manufacturing.
Comprehensive scientific background in biotechnology and/or protein science.
Experience and understanding of current pharmaceutical environment including economic and regulatory challenges.
Experience working in cross‑functional project team and complex environments (e.g., activities across different sites).
Languages
Fluent in English.
Why Choose Us
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.
Equal Opportunity Employer
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information or any other characteristic protected by law.
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Project Leader CMC, Mammalian Projects Cluster
Location
Framingham, MA
About the Job
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.
Main responsibilities
The early‑stage CMC Project Leader 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 PCS to POC.
Lead 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. Oversight of approximately 30‑50 FTEs.
With the CMC team, create 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.
Represent the CMC team as a core member in the Global Project Team, contribute to overall project strategy and execute the appropriate actions within CMC to achieve project goals. Following the TPP, define the Quality Target Product Profile (QTPP).
Act as overall product/process expert for the project, provide technical and scientific expertise on major project topics, drive and lead 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…).
Responsible for quality of CMC contributions to pre‑clinical and early clinical phase activities, and CMC elements for regulatory submissions and consultations. Assess developability/manufacturability together with functions.
Drive evaluation of CMC risks with the team and appropriately escale to Senior Management and Global Project Team, provide mitigation plans, alert decision makers and stakeholders to risks that can impact critical program timelines. In case of scientific/technical issues, coordinate corrective measures across functions in cooperation with all relevant site and department heads.
Responsible for implementation of CMC deliverables within budget, lead and oversee planning of CMC project budget including communication and alignment with global project team and senior management.
About You
Education & Experience
PhD, MS, or other university degrees in biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry). Minimum of 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.
Experience 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), 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 propose alternatives.
Technical skills
Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process development, regulatory CMC, manufacturing.
Comprehensive scientific background in biotechnology and/or protein science.
Experience and understanding of current pharmaceutical environment including economic and regulatory challenges.
Experience working in cross‑functional project team and complex environments (e.g., activities across different sites).
Languages
Fluent in English.
Why Choose Us
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.
Equal Opportunity Employer
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information or any other characteristic protected by law.
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