Website Lenox Executive Search
Job Title: Sr Scientific Associate, Formulation Development
The Senior Scientific Associate’s primary role involves the execution, analysis, interpretation and communication of laboratory experiments in small molecule development. Working closely with their supervisor, sets the objectives of initiatives and takes responsibility for experimental designs. Additionally, the Senior Scientific Associate will perform a variety of well-defined support functions as determined by management and the needs of the department.
- Develop solid dosage forms for clinical and commercial use, generate data for project progression and regulatory filings, conduct optimization and scale up studies.
- Help design, plan, execute, and interpret laboratory experiments, with minimal supervision, to meet established project timelines.
- Maintain accurate and complete laboratory notebook capturing protocols, results and observations.
- Interpret data to form sound conclusions.
- Timely document integrated experimental outcomes in presentations and research reports.
- Perform basic statistical analysis of experimental data
- Assist in technical transfer to CMO partners for clinical trial manufacture
- Initiate experimental troubleshooting on a routine basis, with minimal supervision
Contribute to drafting regulatory filing documentation
- Comply with all relevant Safety and GMP procedures
- Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
- Hands on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales.
- Strong math skills particularly as applied to material/energy balances, and intermediate applied statistical analysis
- Strong technical writing skills
- Excellent verbal and written communication skills
- Successful and efficient multitasking and working on a few projects concurrently
Bachelors degree 4+ years or Masters degree 1+ year in an pharmaceutical or engineering field, material science or chemical engineering preferred, or a degree in a related physical science field with similar core course requirements
Understanding of QbD and experience with Regulatory filings is a plus