Senior Scientist - Analytical Development

Augustbioservices; Nashville (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

August Bio in Nashville seeks a Senior Scientist to lead complex pharmaceutical R&D activities, design and execute lab experiments, analyze data, and contribute to new drug formulations under cGMP/GLP guidelines.

You will develop and validate analytical methods (HPLC and related techniques), maintain rigorous documentation, and collaborate with regulatory, clinical, and manufacturing teams to ensure high-quality results and ongoing scientific innovation.

Qualifications

• Master's degree in Pharmaceutical Sciences, Chemistry, or related field with significant pharmaceutical development experience.
• Extensive hands-on experience with HPLC and related analytical methods.
• Strong knowledge of cGMP and GLP regulatory requirements and ability to apply them in the lab.
• Excellent problem-solving skills and ability to work both independently and in a team.
• Proven record of scientific publications and conference presentations.

Responsibilities

• Design and conduct laboratory experiments to support drug development projects.
• Analyze experimental data, interpret results, and prepare reports.
• Collaborate with cross-functional teams to ensure project execution.
• Develop and validate analytical methods for quality control using HPLC and related techniques.
• Ensure regulatory compliance (cGMP/GLP) in lab practices.
• Maintain detailed documentation in line with GLP and GMP.
• Conduct quality control checks on data and address quality issues proactively.
• Provide mentorship to junior scientists and contribute to new scientific approaches.

Skills

Analytical techniques (HPLC)

Independent work

Problem solving

Publications

Education

Masters in Pharmaceutical Sciences, Chemistry, or related field

Job description

Senior Scientist at August Bio will beresponsible 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.

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

• Mastersin 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

• Prolongedperiodssitting at a desk and working on a computer.
• Must be capable of wearing allappropriate PPEscorrectly during handling of hazardous substances
• Some work may require extended periods of time standing at a lab bench, cleanroomor stability chamber
• Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e.accurately read meniscus)
• 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 isrequirefor loads exceeding 50lbs.