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Adma Biologics - Boca Raton, FL

posted about 1 month ago

Full-time - Mid Level
Boca Raton, FL
Chemical Manufacturing

About the position

The Scientist I, Analytical Development at ADMA Biologics is responsible for providing analytical support for process development and manufacturing. This role requires technical proficiency, scientific creativity, and collaboration with other departments to develop and implement analytical techniques for protein quantification and characterization. The position involves executing routine analytical methods, troubleshooting technical procedures, and ensuring compliance with regulatory standards.

Responsibilities

  • Provide analytical support for process development and manufacturing.
  • Develop, implement, and execute routine analytical techniques for protein quantification and characterization.
  • Design and execute analytical studies to support protein characterization and quantitation.
  • Perform experiments to generate data for validations and special projects.
  • Evaluate and interpret test and experimental data using Excel or other software.
  • Collaborate with other departments to select, qualify, and implement reference standards.
  • Execute assigned tasks within timelines under minimal supervision.
  • Troubleshoot technical procedures, methodology, and instrumentation.
  • Perform instrument calibration or qualification according to written procedures.
  • Serve as primary authors, reviewers, and approvers of regulated documents.
  • Review and approve cGMP documentation generated by other analysts.
  • Follow Standard Operating Procedures (SOPs) and adhere to cGMP guidelines.

Requirements

  • Bachelor of Science (BS) in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is required.
  • A minimum of 4 years of related lab experience with a BS is required.
  • Experience in Chemical/Biochemical testing is required.
  • Experience in a regulated environment (FDA, EPA, etc.) is required.
  • Knowledge of FDA and cGMP requirements is required.

Nice-to-haves

  • Master of Science (MS) in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is preferred.
  • PhD in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is preferred.
  • A minimum of 2 years of related lab experience with a MS is required.

Benefits

  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks' Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Company paid shuttle to the Boca Tri-Rail station
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