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