Jobs · Analyst · Tennessee

Senior Scientist - Analytical Development

August Bioservices, LLC · Nashville, TN · 4 days ago
On-siteAnalystFull-time

Key Responsibilities

  • Independently design and conduct laboratory experiments to support drug development projects, including formulation optimization, stability studies, and bioanalytical assays.
  • Analyze experimental data, interpret results, and prepare comprehensive reports to inform decision-making.
  • Collaborate with cross-functional teams (e.g., clinical, regulatory, manufacturing) to ensure seamless project execution.
  • Develop and validate sensitive and specific analytical methods for the quality control testing of pharmaceutical products using various techniques like HPLC, dissolution, and other relevant analytical methods.
  • Ensure analytical methods comply with regulatory requirements (cGMP) for accuracy, precision, specificity, and robustness.
  • Maintain detailed documentation of experimental procedures and results in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
  • Conduct quality control checks on experimental data and ensure data integrity.
  • Proactively identify and address potential quality issues.
  • Provide technical guidance and mentorship to junior scientists on the team.
  • Contribute to the development of new scientific approaches and technologies.

Qualifications

  • Masters in Pharmaceutical Sciences, Chemistry, or a related field with significant experience in pharmaceutical development.
  • Extensive hands-on experience with analytical techniques like HPLC and other relevant analytical methodologies.
  • Strong understanding of regulatory requirements (cGMP, GLP) and ability to apply them in laboratory practices.
  • Excellent problem-solving skills and ability to work independently and as part of a team.
  • Prominent track record of scientific publications and presentations at conferences.

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