Molecule Steward, Principal

Job description

Molecule Steward, Principal

Department Description:

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 (primarily development, technology transfer, process validation, commercial drug substance, and some aspects of 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.

Key Responsibilities:

·  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, product technical agendas, and product specifications
·  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

Basic Qualifications:

·  Ph.D. 10+ years' experience, MS 12+ years', BS 15+ years' in a scientific disciplineExcellent problem solver and ability to think and work creatively
·  Experience with biopharmaceutical process development, production operations (cell culture, purification, etc.), scale-up and process validation

Preferred Qualifications:

·  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
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​A bility to evaluate new technologies

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Ability to collaborate and influence at all levels across the Sanofi networks and Contract Manufacturing Organizations (CMOs) with equal effectiveness

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Ability to set ambitious targets and successfully drive results

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In depth scientific knowledge of manufacturing processes (cell culture and purification), analytical methods, and statistical analysis

· 
Sound understanding of process/assay development, technology transfer, process validation/process performance qualification, continued process verification (CPV), commercial manufacturing and control, and Quality Systems

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Ability to share and apply knowledge in support of technical challenges

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Strong technical networker and ability to work in a matrix environment

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Excellent interpersonal skills and team-player

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Ability to lead and drive discussions/projects, closely collaborate, and build cross-functional network partnerships in order to influence aligned and/or best practices across the Biologics network

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Experience driving risk assessments

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.

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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.