What are the responsibilities and job description for the Associate Scientist position at TSR Consulting Services, Inc.?
Job Description
Our client, a leading pharmaceutical company, is hiring an Associate Scientist on a contract basis.
Work Location:
Devens, MA - 100% on site
Responsibilities:
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Work Location:
Devens, MA - 100% on site
Responsibilities:
- 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, corporate, 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 Large Scale Cell Culture & Single Use facility.
- Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
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