At BioDuro, we are a group of competent individuals, fiercely committed to Collaboration and Possibility. We are looking for Analytical Development Chemist to join our team.
The Chemist work to develop chromatographic methods for assay, impurities, dissolution, content uniformity, blend uniformity, and equipment cleaning verification in the Analytical Development laboratory. The Chemist will work with HPLCs, chromatographic software and spreadsheets, dissolution apparatus, water content determination, balances, pH meter, and stability chambers on a daily basis to develop methods for and to tests investigational clinical drug products. He/she will also be a testing and review resource for the Quality Control group when needed.
• Essential Job Functions:
Hands-on experience using state of the art HPLCs, dissolution apparatus, use and navigation in chromatography software, small laboratory instruments such as balances and pH meters, creating and using spreadsheets to summarize data, serial diluting of solutions, and calculation of results.
• Independently designs and performs complex scientifically sound analytical development and method troubleshooting experiments
• Independently performs development and phase-appropriate validation of analytical methods to suit its purpose
• Provides technical guidance internally to the analytical, formulation and manufacturing teams on the analytical methodologies and issues
• Routinely acts as project leader on multiple QC and stability projects - reviews and evaluates analytical data from a scientific and compliance perspective and communicates technical results to the client
• Prepares method development reports, stability/validation protocols and reports
• Proven ability to develop highly specific analytical methods for a wide variety of chemical compounds.
• Exceptional GMP documentation skills is a must for this position.
• Review of GMP notebook entries, spreadsheets, and completion of forms to ensure compliance with applicable SOPs.
• Ability to adapt to a fast pace dynamic environment where priorities can change rapidly.
• Highly proficient written and verbal communication skills with employees and clients are essential.
Knowledge and Skills Required:
Education: BS/MS/PhD in Chemistry or a related scientific discipline
Experience: 4-12 years’ experience in analytical chemistry developing methods in chromatography (reversed phase, normal phase, cation exchange, etc.).
Full computer literacy and knowledge of basic scientific principles and practices.