What are the responsibilities and job description for the Associate Scientist position at Sunrise Systems, Inc?
Job Title: Assistant/Associate Scientist
Location: Devens, MA 01434
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
Note:
- 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.
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, 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.
Education/ Experience:
- 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.
IND_EGNIT
Job Type: Contract
Salary: $44.00 - $48.00 per hour
Schedule:
- Monday to Friday
Work Location: In person
Salary : $44 - $48
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