Assistant/Associate Scientist
Onsite required for Training
Hybrid 50/50 once training is successfully completed
Work Schedule: Mon - Fri, Business Hours *Some weekends required based on the needs of the Business*
Provides technical expertise for large-scale commercial manufacturing involving column chromatography, microfiltration, ultrafiltration, nano-filtration, and cryogenics / drug substance handling unit operations for investigation and resolution of process deviations, development, and interpretation of data trending.
Develops, drafts and executes protocols per corporate, site and regulatory requirements to support qualification and validation activities.
On-the -floor support for process related issues
Performs data collection and analysis for process monitoring
Demonstrates a strong knowledge of cGMP compliance, Client corporate, site and regulatory agency requirements and procedures and incorporate into all assigned projects.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for Client Devens Large Scale Cell Culture & Single Use facility.
Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
Knowledge or experience in upstream & downstream unit operations and technical writing (validation and regulatory document authoring) attained through prior experience or studies resulting in a B.S. in biology, chemistry, and/or engineering, a related discipline, or its equivalent.
MS or BS in Chemical/Biochemical Engineering or related field with 4-7 years, respectively, or relevant industrial and/or academic experience
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