About the role
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