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.
Major Job responsibilities and requirements:
- May lead a small group of individuals of bachelor to Ph.D. level and lead multiple projects
- Lead the development of robust downstream processes that can be scaled to large chromatography unit operations.
- Lead scaling up and implementation of downstream processes at manufacturing scale. Lead the examination of novel downstream technologies for manufacturing therapeutic proteins.
- Lead efforts to achieve better understanding of licensed purification processes with emphasis on scale down model development for supporting on-going commercial manufacturing and productivity improvement.
- Provide scale-down support for manufacturing excursions, deviations and other challenges
- Provide comprehensive packages that support equipment design and process technology transfer to manufacturing site(s)
- Conversant with/in DOE, MVA, APC and other techniques used to determine the Design and Operating Space for downstream processes.
- Serve as a subject matter expert on protein purification and engineering.
- Lead efforts with colleagues from across Genzyme sites to achieve standardization and harmonization of downstream development and manufacturing practices.
- Keep abreast of new developments and technologies in areas of downstream processing. Attend and present at external technical forums to remain current with technology and regulatory guidelines.
- Publish in first class technical journals.
- Manage direct reports
· PhD in Biochemistry/chemical Engineering (or equivalent) with 3-6 years of industrial experience in development of downstream process for manufacturing of hormones and recombinant proteins including monoclonal antibodies.
· Experience in managing others and a proven track record of presentations and publications
· Having scaled up the processes and provided manufacturing support for the processes is desirable.
· Familiarity with US and international regulatory documentation and requirements and international regulatory and quality guidelines in the biopharmaceutical industry.
· Exceptional interpersonal skills and ability to work effectively in a matrix organization.
· Excellent organizational and communication skills.