CMC Project Leader, Genomic Medicine

Position Overview & Key Accountabilities:

• The CMC PL is accountable for the CMC project activities of gene and/or cell therapy projects of Sanofi’s R&D pipeline from early to late clinical phases up to submission and approval.

• For this mandate, he/she leads a cross-functional CMC team with functional members/sub-team leaders from CMC R&D and IA, including GMU DS platform, Drug product & formulation platform, Bioanalytics, Device development, Quality, Regulatory CMC, CMC dossiers, Project Management and Demand & Supply as well as IA representatives from commercial manufacturing and/or MSAT and Industrial Product Leader.

• 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 (including IA topics) 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/IA cross-functional governance meetings (Technical Review meetings, CMC Boards, DWG, IDCC).

• He/she is responsible for quality of CMC contributions to clinical and PPQ work packages (DS/DP/Analytics), and CMC elements for regulatory submissions and consultations. He/she drives technical excellence, initiates and oversees CoGs evaluations and align project strategy with commercial expectations in close collaboration with the Industrial Product Leader.

• Within the CMC team, he/she drives the evaluation of CMC risks and appropriately escalate to Senior Management (e.g. 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 local and department heads and global functions as needed.

• 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.

Basic Qualifications:

• Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering, biochemistry, chemical engineering or related discipline with a minimum of 14 years of relevant experience or PhD with minimum of 10 years of relevant experience

• Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process dev, regulatory CMC, manufacturing, etc.

• Experience in cell/gene therapy development/manufacturing

• Expertise in project management and risk assessment

• Confirmed experience in working in project team and in complex environment (e.g., transversal assignments across different sites)

• Understanding of regulatory guidance and requirements for gene or cell therapy products, including experience in IND submissions

• Fluent in English

Behavioral Competencies:

• Strong leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders, excellent communication skills, stakeholder management and networking

• Experience in leading international and/or multi-cultural teams

• Ability to work in a matrix organization

• Influencing and negotiation skills to build solutions and partnership

• Objectives and deliverables / results oriented. Capable to deliver under high pressure

• Ability to interact effectively with executive/senior management and external bodies (e.g., auditors, health authorities, etc.)

• Take responsibility for decisions and accountable for results

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; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.