Senior Scientist

18 hours ago

sanford, United States Insight Global Full time

Must haves:

  • Bachelor's Degree in Science or related field
  • 3+ years of experience in bioanalytical, chemistry or microbiology (at least 2 of the 3)
  • Experience running HPLCs and plate based assays
  • Experience in pharmaceutical manufacturing

Plusses

  • Masters or Doctorate in related field
  • Method transfer and method validation experience

Day to day:

A pharmaceutical manufacturing client is seeking a QC Scientist to provide critical support within their Method Transfer and Development Group. This site has flexible, multi-product manufacturing capabilities and facilities focused on vaccines intermediates and drug substance, and gene therapy drug substance and drug product. The vaccine manufacturing capabilities center on large-scale microbial fermentation, purification, conjugation and cell banking. As a scientist, you will be working with the client to transfer methods for a combination diagnostic product into the site. This role will be Monday - Friday, first shift.

Responsibilities

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
  • Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
  • Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
  • Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.
  • Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
  • Train junior colleagues and develop training plans and oversee training activities for groups.
  • Responsible for contributing to and/or handle laboratory investigations for events and Out of Specification results.
  • Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
  • Perform laboratory support functions and maintain work area in a neat and orderly manner.
  • Write Standard Operating Procedures, technical reports, project plans and other documents independently.

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