Sanofi Group Molecule Steward Principal in Westborough, Massachusetts
Molecule Steward Principal
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) 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.
The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function, which together with the site-based MSAT functions, provides strategic direction and technical and operational support to ensure that site-based and network goals and objectives are achieved. The global MSAT and site-based MSAT functions are the primary owners of the technical agenda and process and product control strategies for commercial products and product-related programs within the Sanofi Specialty Care Operations (SCO) perimeter.
POSITION OVERVIEW / KEY RESPONSIBILITIES\
The Molecule Steward will ensure a continuous, integrated knowledge base and understanding of all the molecule attributes and of the drug substance and product production processes. This includes the development and maintenance of the 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, leading the development of, and later maintaining, the Process Control Strategy, maintenance of the Product Development Files, leading drug substance and drug product specification discussions and supporting individual sites in the development of Operating Control Strategies (OCS). The Molecule Steward becomes involved as the technical lead at the Process Installation Stage (Stage 5) of the Drug Development lifecycle.
This position will be responsible for new or next generation biologic or monoclonal antibody products as assigned from the Sanofi Specialty Care Operations portfolio.
The Molecule Steward ensures acquired knowledge is leveraged and applies consistent technical oversight of the process, analytical controls and product.
The Molecule Steward:
Serves as a product technical expert and plays a pivotal role in providing input and context in cases of significant deviations, investigations and continuous improvements projects
Masters scientific/technical aspects of the process/product/analytical development, registration dossier and dossier supplements and commercial DS and DP manufacturing history
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
Stability and degradation pathways
Process and assay capability
Consults on critical investigational events/technical studies
Consults on impact assessments of global change controls
Is responsible for keeping product/process knowledge up to date and accessible through the Product Development File repository
Is accountable for the development and maintenance of the Process Control Strategy
Supports the sites with Operational Control Strategy development
Consults on the process risk profiling effort and identification of required corrective actions
Consults on the technical aspects of the Periodic Product Review (PPR) process
Serves as the technical lead of the Specification Development process
Ensures the establishment of the post-approval lifecycle agenda and workplan for the product as a whole
Maintains oversight of the agenda
Understands the scientific/technical and regulatory rationale that drive projects
Provides advice to the leader of major technology transfers
Stays current on industry best practices and regulatory/industry guidance documents related to process-, product-, and control technology.
Ph.D. 8 years’ experienceORMS 10 yearsORBS 14 years’ in a scientific or engineering discipline
Excellent problem solver and ability to think 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
Comparability program design
Understands the importance/relevance of various regulatory and Boards of Health requirements
Hands on experience with some aspects of the proposed molecule whether in process development, product development, scale-up, or operations
Ability to evaluate new technologies
Excellent and effective verbal and written communication skills and ability to influence across the SCO and Sanofi networks and Contract Manufacturing Organizations (CMOs)
Ability to influence at all levels throughout the organization with equal effectiveness
Ability to set ambitious targets and successfully drive results
In depth scientific knowledge, analytical skills, and statistical analysis skills
A 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 bridges
Results oriented – Sets ambitious tangible objectives, takes personal responsibility for achieving goals
Collaborative – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science, regulatory and commercial organizations
Decisive – Makes decisions when needed even if outcomes are difficult, accepts accountability for results and makes choices using sound judgment
Strategic – Demonstrates an understanding of key trends that impact our business and can translate that understanding into clear action plans
Leadership – Sets clear priorities for the organization and empowers the team to meet challenges and take action. Encourages collaboration with and beyond the team.
Continuous improvement – Drives a continuous improvement mindset
Develop people – Takes responsibility for developing people when acting as a Team Leader. Learns from experience and helps others to do likewise. Provides feedback on a regular basis
Job: Laboratory/Process/Device Development
Primary Location: United States-Massachusetts-Westborough
Job Posting: Oct 17, 2016, 6:58:49 PM
Job Type: Regular
Employee Status: Regular