Senior Scientist - Analytical Development
Nashville, Tennessee, United States of America
Full Time
1 week ago
About this role
Senior Scientist at August Bio will be responsible for leading complex research and development activities in the pharmaceutical field, including designing and executing laboratory experiments, analyzing data, and contributing to the development of new drug formulations, while ensuring adherence to all regulatory standards and company quality control procedures, often with a focus on analytical method development and validation for quality control testing of pharmaceutical products.
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.
- Proven track record of scientific publications and presentations at conferences.
Physical Requirements
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Prolonged periods sitting at a desk and working on a computer.
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Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances
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Some work may require extended periods of time standing at a lab bench, clean room or stability chamber
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Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e. accurately read meniscus)
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Ability to lift, carry, push, or pull up to 40lbs. occasionally, and up to 30lbs. frequently. Two-person team lift or use of mechanical assist device is require for loads exceeding 50lbs.