Summary:
The Senior Manufacturing Sciences & Technology Associate (MAST) will provide technical support to drug substance manufacturing operations for late-stage clinical and commercial projects.
Main Responsibilities:
* Perform detailed data analyses and root cause analyses to identify solutions to complex problems.
* Leads continuous process monitoring efforts and applies statistical tools to identify and improve productivity, efficiency, and robustness in manufacturing.
* Actively engages in the identification, sharing, facilitating implementation, and adaptation of best practices cross-functionally and between manufacturing sites.
* Make recommendations for action plans to solve issues and minimize recurrences.
* Champions and implements change controls, leads selection and implementation of new equipment and materials at manufacturing facilities to improve existing and new processes.
* Drives technology transfer activities to internal and external manufacturing sites and corporate partners and serves as the technical expert in supporting manufacturing at CMOs.
* Performs fit-to-plant projections and plan for new processes and implements processes in multiple manufacturing facilities.
* Guides technical development early in the product life cycle to ensure facility/operational considerations are factored into process decisions.
Required Qualifications
* Bachelor's degree, or Masters, in Biology, Chemistry, Biochemistry or related life sciences or engineering field with a minimum of five to eight years of experience.
* Direct hands-on experience with commercial scale bio pharmaceutical manufacturing support for mammalian cell culture and/or purification processes
* Experience with Deviation, CAPA and Change Control systems
* Solid understanding of overall manufacturing process, and strong technical knowledge of either upstream or downstream unit operations
* Knowledge of current Good Manufacturing Practices and US/EU regulations
* Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
