Sanofi Group Molecule Steward in Westborough, Massachusetts
The Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that site and network goals and objectives are achieved. MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support, and drive process lifecycle management for biologics drug substance operations for commercial products and product-related programs within Sanofi’s Industrial Affairs Biologics Platform product perimeter.
Molecule Steward, Principal:
The Molecule Steward will ensure a continuous, integrated knowledge base and understanding of all the molecule attributes and of the drug substance manufacturing processes. This includes maintenance of the drug substance process and product control strategies. A critical aspect of the role is to ensure a “line of sight” throughout the supply chain from critical raw materials through distribution and across the business (development, technology transfer, validation, commercial drug substance and drug product manufacturing) to ensure appropriate control of product quality.
The Molecule Steward is the focal point for the management of technical knowledge, participating in the development of, and later maintaining, the Control Strategy, maintenance of the Product Knowledge Repository (product development files), drug substance and drug product specification discussions and supporting individual sites in the development of Operating Control Strategies (OCS).
This position is responsible for new or next generation products as assigned from the Sanofi Industrial Affairs Biologics Platform product portfolio. These may include enzyme replacement therapy products, monoclonal antibody products, or products derived from other modalities as they are introduced to the Biologics Platform via internal channels or alliance partnerships (Regeneron, Bioverativ, Ablynx, etc.). The Molecule Steward ensures acquired knowledge is leveraged and applies consistent technical oversight of the process, analytical controls and product.
Serves as a product technical expert and plays a pivotal role in providing input and context in cases of significant deviations, investigations, continuous improvement projects, and product technical agendas
Masters scientific/technical aspects of the process/product/analytical development, registration dossier and dossier supplements and commercial DS and DP manufacturing history
Provides expert technical/scientific advice when authoring regulatory submissions, briefing documents, responses, etc. to meet global regulatory requirements by leveraging acquired technical expertise and industry experience
Demonstrates strong strategic thinking/skills including the ability to make complex decisions and willingness to defend difficult positions
May have direct interactions with regulatory authorities (US and ex-US) and must be able to act as the voice of the company in articulating and negotiating for the company’s proposals/positions as the MSAT technical expert
Has in depth understanding of:
Why process parameters are critical or not and the rationale of their control strategy
Raw material and excipient criticality with regard to product and process performance
Product stability and degradation pathways
Process and assay capabilities
Consults on critical investigational events/technical studies
Consults on impact assessments of global change controls
Consults as a technical subject matter expert during site regulatory and/or corporate audits, when requested
Responsible for keeping product/process knowledge up to date and accessible through the Product Knowledge Repository
Accountable for the maintenance of the Control Strategy
Supports sites with Operational Control Strategy development, when requested
Consults on the process risk profiling effort and identification of required corrective actions
Consults on the technical aspects of the Periodic Product Review (PPR) or Annual Product Review (APR) process
Serves as the technical lead during the Specification Development process
Provides technical input to establishment of the post-approval lifecycle agenda and workplan for the product as a whole
Understands the scientific/technical and regulatory rationale that drive projects
Develops and provides technical approaches to the leader of major technology transfers and/or product team leads
Stays current and maintains solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines, and industry best practices; drives to adopt industry best practices at Sanofi
Ability to identify risks and manage risks through mitigation and communication
Excellent coordination skills including planning, organizing and ability to motivate others
Ph.D. 10+ years’ experience,
MS 12+ years’ or , BS 15+ years’ in a scientific discipline
Excellent problem solver and ability to think and work creatively
Experience with biopharmaceutical process development or production operations, scale-up and validation
Mammalian cell culture, purification and assay development and analytical characterization experience specific to biologics and/or monoclonal antibodies
Product comparability and process performance qualification design
Understands the importance/relevance of various regulatory and Boards of Health stances/requirements
Hands on experience and in-depth scientific knowledge of biotech products whether in process development, product development, scale-up, or operations
Excellent and effective verbal and written communication skills
Ability to evaluate new technologies
Ability to collaborate and influence at all levels across the Sanofi networks and Contract Manufacturing Organizations (CMOs) with equal effectiveness
Ability to set ambitious targets and successfully drive results
In depth scientific knowledge, manufacturing processes, analytical skills, and statistical analysis skills
Sound understanding of process/assay development, technology transfer, validation, commercial manufacturing and control, and Quality Systems
Ability to share and apply knowledge in support of technical challenges
Strong technical networker and ability to work in a matrix environment
Excellent interpersonal skills and team-player
Ability to lead, closely collaborate and build cross-functional network partnerships
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life