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
Prolonged periods sitting at a desk and working on a computer.
Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances
Some work may require extended periods of time standing at a lab bench, clean room or 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 is require for loads exceeding 50lbs.
Skills Required
- Masters in Pharmaceutical Sciences, Chemistry, or related field with significant pharmaceutical development experience
- Extensive hands-on experience with analytical techniques, specifically HPLC and dissolution testing
- Experience developing and validating analytical methods for QC (accuracy, precision, specificity, robustness)
- Strong understanding and application of regulatory requirements (cGMP, GLP) in laboratory practices
- Experience with formulation optimization, stability studies, and bioanalytical assays
- Proven track record of scientific publications and conference presentations
- Ability to prepare comprehensive experimental reports and maintain detailed GLP/GMP documentation
- Demonstrated ability to provide technical guidance and mentorship to junior scientists
- Ability to wear appropriate PPE, perform extended bench work, accurately read volumetric apparatus, and lift up to 40 lbs (with team or mechanical assist for >50 lbs)
What We Do
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.
