Sr Director Commercial Cell Culture Development Job Listing at Genzyme Corporation in Framingham, MA
Sr Director, Commercial Cell Culture Development-31735
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
The Senior Director of Commercial Cell Culture Development (CCCD) reports to the Vice President of Late Stage Process Development (LSPD), Biologics Development/Science, and is responsible for directing and managing various activities related to cell culture development for Genzyme's processes that are in late stage development or licensed. The incumbent will manage a team of 25+ engineering and scientific personnel. He/she will ensure the highest standards of safety and environmental compliance are maintained in the workplace, and will operate under established corporate standards for new process development. The individual is expected to develop a long-term technical/organizational strategy and a short-term plan, which will be integrated with the objectives of the other departments in Genzyme Science.
· Serve as a Senior Staff member of LSPD and contribute to the strategic and tactical decision making. Provide senior representations on Science and Corporate project teams. Assure that project activities/commitments are fully supported.
· Enhance department with new competencies, technical and leadership depth. Support staff development to maximize individual and team performance. Serve as coach/mentor to staff and develop a robust succession plan.
· Ensure that development projects are progressing according to plan. Provide leadership in the development of new processes, including scale up and technology transfer,
• Oversee platform technology development utilizing internal and external expertise. Bridge biology/biochemistry with bioprocess engineering related to cell culture. Develop a network of leading academic and industrial experts.
· Keep abreast of the newest developments/technologies in areas of responsibility. Develop strategy and business plans for the implementation of appropriate platform technologies.
· Interact with colleagues from various Genzyme functions, in particular Early Development, Bioanalytical Development and relevant Sanofi groups, to coordinate project progression.
· Provide CMC support and guidance for process development.
• Upgrade and maintain cell culture lab to meet highest standards.
• Attend external technical forums to remain current with technology and regulatory guidelines. Publish in first class technical journals.
We are looking for an individual with a Ph.D. or advanced degree in Biochemical Engineering, Cell Biology or related fields. A minimum of 15 years of biopharmaceutical product development experience is required.
Key capabilities include technical depth and experience in:
· Biochemical engineering, cell biology, upstream steps of bioprocessing, with a particular focus on cell culture
· Small and large scale bioprocessing; scale up and scale down
· Solid understanding of cell biology, biochemistry, protein chemistry, analytical approaches, and related fields
· Mammalian cell culture technology: fed-batch and perfusion platforms. Solid understanding of continuous bioprocessing technology.
· Technology transfer and GMP environment
· US and international regulatory documentation and requirements, international regulatory guidelines in the biopharmaceutical filed
· Proven experience in leading and developing technical groups and teams.
· Excellent written and verbal communication skills.
Job : Manufacturing Development
Primary Location : United States-Massachusetts-Framingham
Job Posting : Dec 11, 2012
Shift : Day Job
Job Type : Regular
Employee Status : Regular
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