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Bio Analytical Scientist

Company: System One
Location: Warren
Posted on: November 12, 2021

Job Description:

Title: Bio Analytical Scientist Location: Warren, NJ Start date: ASAP Responsibilities:

  • Manage analytical method transfer from development to QC. Author and review analytical method transfer protocol and report. The methods may include qPCR, flow cytometry, ELISA, cell counting et al.
  • Author and review analytical method qualification protocols and report
  • Participate execution of analytical method qualification
  • Trained on analytical methods and work as SME for qPCR and flow cytometry methods to support QC activities, leading deviation investigation, identify root cause, provide solution for analytical method issues.
  • Author and review SOPs as required
  • Perform tracking/trending of data to contribute to the life-cycle management of an analytical method
  • Coordinate method SME for QC analyst training
  • Have good communication skills and be able to work cross-functionally with QC, QA, analytical development and CRO. Build relationships with cross-functional team
  • Manage equipment procurement and coordinate equipment IQ/OQ
  • Maintain a basic knowledge of cell therapy development and awareness of competitive landscape
  • Ensure proper operation and perform routine maintenance of all laboratory equipment. Ensure that all equipment and personnel are remain in compliance with cGLP/cGMP, FDA/EMA requirement, appropriate SOPs and corporate policies
  • Maintain a safe workplace in accordance with company and OSHA policies/procedures. Requirements:
    • BS or MS in Biology or related discipline with 5 plus years of recent, relevant experience
    • Basic: knows the fundamental concepts of the specialty field
    • Experience of molecular assays, flow cytometry-based assays and cellular assays
    • Proficiency in analytical skills: statistical analysis and effective presentation of analysis to other groups
    • Strong verbal and written communication skills and interpersonal skills
    • Ability to write scientific technical protocols. Reports and SOPs that require minimal revision on content
    • Ability to work with minimal technical supervision and perform operational tasks independently
    • Able to assess risk and develop contingency plans to mitigate risk
    • Highly motivated and driven to acquire new skills
    • Expertise in mammalian cell culture and diverse analytical techniques preferred
    • Experience in working in a GMP regulated environment or QC is a plus
    • Comply with the Environmental Health and Safety Requirements 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.

Keywords: System One, Elizabeth , Bio Analytical Scientist, Other , Warren, New Jersey

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