TechDigital Group
Engineering - Assistant/Associate Scientist
TechDigital Group, Harvard, Massachusetts, us, 01451
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, andinterpretation 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.
Education and Experience: •MS or BS in Chemical/Biochemical Engineering or related field with 4-7 years, respectively, or relevant industrial and/or academic experience
Additional Job Requirements: Position Handles Hazardous Materials #J-18808-Ljbffr
• 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, andinterpretation 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.
Education and Experience: •MS or BS in Chemical/Biochemical Engineering or related field with 4-7 years, respectively, or relevant industrial and/or academic experience
Additional Job Requirements: Position Handles Hazardous Materials #J-18808-Ljbffr