Project Leader CMC, Mammalian Projects
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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.
Lead a cross-functional team and sub team of approximating 30 to 50 team members
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 and functions as core member in the Global Project Team, contributing to overall project strategy and executing the appropriate actions within CMC to achieve project goals.
Define the Quality Target Product Profile (QTPP)
Act as overall product and process expert for the project, providing technical and scientific expertise on major project topics while leading technical and scientific discussions in alignment within the CMC tin cross-functional governance meetings
Responsible for quality of CMC contributions to pre-clinical and early clinical phase activities and CMC elements for regulatory submissions and consultations.
In collaboration with the functions, assess the options for developability/manufacturability.
Drive the evaluation of CMC risks and appropriately escalate to CMC Senior Management as needed with mitigation plans. He/she
Alert decision makers and stakeholders to risks that can impact critical program timelines and in the case of scientific/technical issues, coordinate corrective measures across functions within R&D in cooperation with local department heads.
Responsible for implementation of CMC deliverables within budget considering external and internal costs.
Lead planning of CMC project budget including communication and alignment with global project team and senior management.
Bachelor’s or master’s degree in biotechnology, pharmaceutical engineering, pharmaceutical analysis, biochemistry, chemical engineering or related discipline with a minimum of 14 years of relevant industry experience or a PhD with minimum of 10 years of relevant industry experience.
Expertise in Biologics CMC area, with proven experience in at least 1 scientific area, e.g., analytics, process dev., 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 cross functional project teams and in complex environment (e.g., activities across different sites)
Excellent communication skills, fluency in English
Coordinate several activities and stakeholders, good communication skills, experience in stakeholder management and networking
Experience in leading teams
Ability to work in a matrix organization
Influencing and negotiation skills to build solutions and partnership
Experience interfacing with external bodies (e.g., auditors, health authorities, etc.)
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
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.
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