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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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