Sanofi Group Director, Upstream Continuous Biomanfacturing in Framingham, Massachusetts
Director, Upstream Continuous Biomanfacturing
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.
Job Responsibilities/Department Description:
The Continuous Manufacturing Skill Center is a global function within Sanofi whose mission is to develop and implement a commercializable Integrated Continuous Biomanufacturing (ICB) platform in R&D and Industrial Affairs (IA) for the production of therapeutic proteins. ICB provides many important strategic advantages for manufacturing of therapeutic proteins through process intensification, integration and simplification. By working with other Skill Centers, Bioprocess Development and IA, this department is responsible for the development of “state of the art” and innovative technologies required to demonstrate and mature the fully continuous end-to-end protein production platform for therapeutic enzymes, different types of antibodies and other protein biologics products. This group will support implementation for clinical trial and commercial manufacturing in existing facilities as well as in the “factory of the future”. This is an exciting opportunity with the potential to have a significant impact on future manufacturing strategies to be used by Sanofi and the biopharmaceutical industry as a whole.
We are seeking a Director with extensive experience in mammalian cell culture process development. The successful candidate will be expected to drive the development of highly intensified, state-of-the-art, chemically-defined and highly productive upstream processes and work collaboratively to integrate such processes with downstream operations to define a robust, well-controlled, and well-understood fully continuous biopharmaceutical manufacturing platform. This person needs to be a motivated, organized, flexible and creative individual. They must be a good problem solver, willing to take calculated risks if necessary to achieve the desired goals, must be able to set goals and define strategies to achieve them, and to provide leadership within a critical global function. This person must be able to establish good working relationships with vendors and internal colleagues (e.g. engineering, downstream, analytical) key to the establishment of a fully integrated platform, and to effectively represent these activities and the platform to senior management and across a global organization. They will also be required to support technology transfer of resulting platforms into cGMP/commercial biomanufacturing facilities. This is an exciting opportunity to participate in leading the implementation of continuous manufacturing into real world applications and to play a role in redefining how biomanufacturing is performed at Sanofi and within the industry.
Ph.D. in Cell Biology, Biochemistry, Bioengineering, or related fields and 10 years of relevant industry experience.
Experience working independently, manage teams, multitask, and to provide leadership.
Experience with the application of scientific and technical knowledge in contemporary bioreactor-scale mammalian bioprocess development and process optimization.
Experience with downstream process development operations, objectives and principals
Experience working collaboratively and productively with interdisciplinary teams/functions, downstream counterparts, and external vendors to meet objectives.
Must work well within a fast-paced, dynamic and team-oriented environment.
The candidate should be self-motivated, strongly driven to succeed, inquisitive, and have excellent organizational, interpersonal, communication and problem-solving skills.
Familiarity with DeltaV based control systems
Experience with mammalian bioreactor systems ≥100L working volume.
Experience with chemically-defined mammalian cell culture media/feed design and optimization.
Experience with perfusion mammalian cell culture processes
Experience with formal technology transfer strategies and objectives
Experience with integration of existing and new technologies/instrumentation into automated work-flow.
Ability to address, troubleshoot and resolve issues that arise with the aforementioned integrated systems and other general/automated laboratory equipment.
Experience with Design of Experiments (DOE) approach for process development and characterization desirable.
It is desirable to have a solid understanding of current Good Manufacturing Practices (cGMPs) requirements and considerations.
Job: Laboratory/Process/Device Development
Primary Location: United States-Massachusetts-Framingham
Job Posting: Oct 7, 2016, 8:32:23 AM
Job Type: Regular
Employee Status: Regular