Supervisor Analytical Services

Description 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.

Requirements

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