Summary

This position is primarily responsible for the supervision of the daily operations of a team of analysts whose activities consist of laboratory testing of raw materials, packaging materials, in-process, release and stability samples for pre-commercial drug products and method transfers/validations, as well as conducting lab investigations. 

Scope of Job

Supervisor 3 or more analysts consisting of a Team Leader, Chemists, and Lab Technicians that are responsible for testing of various samples for pre-commercial drug products as well as method transfers/validations. No purchase approval or budget responsibilities. 

Responsibilities 

Project Management

· Develops strategies to ensure effective   achievement of objectives by delegating responsibilities and organizing work   flows while monitoring and evaluating   the completion of tasks and projects

Testing

· Ensure testing is completed on or before   assigned due date

· Communicate material issues or testing delays   to the appropriate internal customer(s) (i.e. Manager)

· Critically   review raw data, chromatography, data sheets/LIMS, and protocols/reports for   accuracy and completeness

Technical Review

· Provides technical support for the evaluation   of development, release, and stability data

· Review method validation protocols and reports

· Review analytical procedures

· Review and approve all necessary   documentations for IND/ANDA/NDA submissions

· Prepare and/or review responses to FDA   deficiency letters

Leadership

· Demonstrates ability to lead a team of   analysts and several projects independently while having a positive impact on   personnel and colleagues

· At all times strive to maintain the   self-esteem of individual team members and the professionalism of the group   as a whole

Team Development

· Participates in the selection,   development/training and evaluation of direct reports by providing ongoing   guidance and support, and write performance reviews and/or evaluations

Experience 

· BS Degree in Chemistry or related field

Minimum of 5 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment