A day in the Life:

Performs a variety of routine to sophisticated sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.

Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines.

Communicates project status to project leader.

Maintains a laboratory notebook and completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.

Performs daily work assignments accurately, and in a timely and safe manner.

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Keys to Success:

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Major in biology or chemistry

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

Knowledge of routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines

Knowledge of applicable regulatory authority, compendia and ICH guidelines

Excellent manual dexterity skills

Good written and oral communication skills

Time management and project management skills

Shown problem solving and troubleshooting abilities

Ability to cross-train on sample preparation techniques with another laboratory group

Ability to work in a collaborative work environment with a team