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Location: Framingham, MA
The Director, Bioassays, will be responsible for transfer, development and implementation of binding and immunoassays for late stage and commercial biologics, providing alignment and coordination within the Sanofi biologics network, leading and implementing novel industry and regulatory practices in the field.
Development and manufacture of biopharmaceuticals is one of the primary focus areas for Sanofi. In-depth knowledge, understanding, development and implementation of analytical, biological and immunological assays is essential for the success of biologics development and manufacture. MSAT is looking for a strong SME and a leader in the field of bio-, binding and immunoassays, to provide leadership, coordinate support, develop Life Cycle Management (LCM) strategy, technology and regulatory strategy for commercial biologics.
As a member of Analytical Science and Technology (AST) in the Manufacturing Science & Technology (MSAT). The MSAT function within Specialty Care Operations (SCO) is responsible for leading technology transfer, implementing control strategy, providing technical process and analytical support and driving process and analytical lifecycle management for biologics drug substance operations. The Director, Bioassays, reports to the Head of AST and is based in Framingham, MA.
AST is a member of a Global Analytical department in MSAT and a partner to Biologics Quality and Manufacturing Departments. AST provides analytical support to commercial manufacturing of biologic drug substance (DS), is responsible for method and platform technology development for analytical life cycle management (LCM) and supports process development for LCM.
Support commercial biologics and analytical LCM
Support technology transfers and 2nd generation process development for biologics DS
Facilitate implementation of digital tools and infrastructure
Advance analytical automation, high throughput capabilities and Process Analytical Technology
Partner with internal and external functions to transfer and implement novel analytical methods and technology
Develop analytical control strategy and support regulatory filings.
AST is a function of Sanofi Biologics Global Manufacturing Science and Technology organization.
Lead and oversee bio-, binding and immunoassay support to commercial biologics and LCM programs
Network with SMEs across Sanofi
Set priorities with input from stakeholders and SMEs across the network to develop technology platforms and study plans
Partner with the stakeholders and SMEs to align on priorities, resources, support and expertise as required
Liaise with SMEs at Sanofi alliance companies and CMOs as appropriate
Actively maintain knowledge of industry best practices related to bio-, binding and immunoassays and relevant technology
Develop and maintain relationships with other biotechnology and biopharmaceutical companies; represent Sanofi externally at industry conferences
Lead and support characterization and comparability studies
Support establishment of control strategy for late stage and commercial biologics
Support regulatory filings as appropriate
Participate and contribute to the leadership and governance practices in AST and MSAT as appropriate
Ensuring compliance with all legal and business requirements and Sanofi policies and practices.
Enable effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility as well as talent attraction and talent exchange with other sites.
PhD with 10+ years of experience, Master with 12+ years, or Bachelors with 15+ years of experience, in Biopharmaceutical Industry
5+Years’ experience in managing direct reports as well as staff and activities in the network and matrix environment
7+ years’ experience with bioassays and immunoassays
Candidate with demonstrated ability to navigate and influence in a highly technical environment will be considered
Demonstrated ability to lead programs and/or projects, ability to influence and must have strong communication skills.
Recognized Thought leader and strongly networked in the field of bioassays, binding and immunoassays.
Familiarity with microbiological safety and viral clearance aspects of bio-manufacturing and control and testing strategy
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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