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.