Job Information
System One Services Associate Scientist in Devens, Massachusetts
Associate ScientistDevens, MA
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Type:Contract
Category:Scientific & Clinical
Job ID:186739
Date Posted:02/23/2021
Title:Associate Scientist
Location:Devens, MA
Start date:ASAP
Responsibilities:
Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation and preparation of regulatory filings
Demonstrates a strong knowledge of cGMP compliance, corporate, site and regulatory agency requirements and procedures
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Large Scale Cell Culture facility
Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process
Participates in the preparation of regulatory filing documents and inspection readiness
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the site
Requirements:
B.S,or M.S. in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
Experience in contributing to the design, modification and optimization of cell culture or fermentation unit operations
Proactively identifies problems and troubleshoots solutions
Organizes and presents data for internal/external scientific meetings
Works independently, in teams and collaborates with other groups in a matrix environment
Leverages emerging trends in biotechnology to solve complex problems
Capable and willing to train others on procedures, operations, new technology, methods or processes
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
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