Genzyme ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme's local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.
Senior Process Engineer
We are seeking candidates with demonstrated expertise and experience in commercial cell culture and/or purification processes with a strong understanding of regulatory requirements in cGMP manufacturing, process characterization and factors impacting process variability. Technical experience in leading process investigations, process analysis and modeling is also desired. This position will serve as a technical lead to projects relating to continuous process and method improvements, regulatory commitments such as CAPAs, process investigations, implementation of new technologies and own site wide technical risk assessment programs and technical initiatives related to the site risk profile. This individual will be a technology leader at Genzyme, involved in driving technical strategy and excellence within Framingham Biologics and across the Genzyme Biologics Technical Operations Network.
Previous experience to a broad range of functions related to cGMP biologics manufacture (manufacturing, development, RA-CMC, validation,compliance)
Demonstrated ability to champion projects and initiatives; ability to drive initiatives across functional groups and organizations, from ""concept to execution""
Experience in conducting and managing large scale process/ product technical risk assessments
Ability to correctly analyze, interpret and apply technical data towards practical actions and outcomes
Demonstrated ""intellectual"" leadership- the ability to question and a passion to drive improvement
Challenges status quo; drives innovation in creative and practical ways understanding the risk/ benefits especially in a fast paced cGMP environment
BS in Engineering or Statistics and 10+ years (or MS 8+ years/Ph.D. 6+ years) supporting commercial cell culture or purification operations.
* Advanced degree in biochemical/ chemical engineering
* Prior experience across multiple areas of a biologics product lifecycle such as bioprocess development, biomanufacturing, regulatory, validation, technical transfer, CMO experience etc. is a plus
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