Scientist - III

Job Duties

• Conduct analysis or experiments by following procedures independently.
• Conduct lot release and stability testing in compliance with GMP/GLP, safety and regulatory requirements to support all development stages.
• Develop and execute experimental plans of limited scope (e.g., method development, characterization studies, instrument qualification) with minimum supervision.
• Assist in developing and validating moderately complex analytical methods to test raw materials, intermediates and final products, or quantify biomarkers in biological matrices.
• Help improve existing complex methods with supervision.
• Analyze and interpret complex data following procedures.
• Learn and apply basic GMP/GLP principles.
• Review test records according to procedures.
• Maintain laboratory safety and alertness for the safety of coworkers and visitors.

• BS with a minimum of 5 years, or MS with a minimum of 3 years of relevant pharmaceutical or biotechnology development experience.

• Working knowledge of biophysical techniques and analytical characterization of peptides and proteins.
• Experience supporting formulation and process development.
• Aseptic processing experience.
• Experience authoring/revising SOPs, work instructions, test methods, batch records, validation protocols, development reports, and validation reports.
• Experience in GLP/GMP regulated environments.
• Excellent oral and written communication skills.
• Ability to work as part of a multidisciplinary team.