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.
Job Responsibilities/Department Description:
The Staff Scientist I, Downstream Processing is responsible for execution of ongoing process development activities to establish process technology for clinical manufacturing of cell and gene therapy based products, in compliance with all current regulatory and corporate quality guidelines. This individual leads collaboration with all supporting groups and departments to ensure technical and operational requirements are established and maintained in order to meet all relevant company, site and departmental development goals.
· Contributes significantly to the development of downstream processing technology for the production of viral and mammalian-cell-based products
· Participates with a team of technical staff to successfully realize departmental technical development goals and objectives including oversight of staff development, goal setting and performance management.
· Responsible for the execution of technical and experimental strategies leading to downstream process definition for clinical manufacturing processing and facilitates troubleshooting and technical analysis
· Acts as a subject matter expert and supports the transfer of process technology to both internal and external clinical manufacturing groups
· Supports the evaluation of new technology and makes recommendations to their implementation in Gene Therapy process development
· Responsible for the generation of technical reports and technology transfer related documentation for downstream processing, and may contribute to the generation of regulatory filings
· Makes recommendations for and participates in the development and implementation of process improvement and strategic growth initiatives for the Gene Therapy Development department.
· Adheres to and supports all safety programs by ensuring personnel safety training is completed and safety equipment is available.
· Participates on the purification development sub-team and participates on project sub-teams as necessary
Ph.D. degree and 0-2 years of relevant experience in the development of downstream processing for biologics.
Must have demonstrated skills and working knowledge of the unit operations associated with biologics manufacturing with a working knowledge of current regulatory requirements.
Ability to manage in a dynamic, fast-paced, safety conscious, multi-product development and manufacturing environment with shifting priorities. Practical experience implementing the principles of Quality by Design (QbD) and Design of Experiments (DOE) in process development are highly valued. Strong presentation skills. Ability to lead and influence teams within the scientific environment in the pursuit of corporate and departmental objectives. Strong commitment to accountability for self and departmental staff for completion of objectives in accordance with established plans.
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