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发帖数: 16 | 1 Senior Director, Commercial Cell Culture Development (req #31735)
Location: Framingham, Massachusetts
Department: Late Stage Process Development, Biologics Development/Science
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 vision and a short-term plan, which will be
integrated with the objectives of the other departments in Genzyme Science.
Major responsibilities
• 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 Process 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.
Education & Experience
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. |
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