Chemist Team Lead

Quality Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for coordinating and participating in the daily activities of a team.
These activities will primarily consist of the analysis and laboratory support for all marketed products.

Essential Functions:

 Coordinate the daily activities of team members, including daily scheduling and tracking, by leading
and organizing team members to provide timely and efficient testing.
 Provide testing completion dates to the QC supervisor and other internal customers, and promptly
communicate any schedule changes.
 Coordinate and perform accurate and timely analysis of finished product samples (i.e. release,
stability, pre-clinical, process verification and validation, in-process) according to current analytical
procedures, SOPs and laboratory guidelines.
 Ensure that all pertinent information regarding the team is entered into the appropriate databases for
tracking and capacity modeling purposes.
 Coordinate and perform analytical method transfers with the AD group to QC.
 Coordinate and perform laboratory equipment calibration and preventative maintenance.
 Work with QC management to provide well-written, accurate and timely reports regarding laboratory
investigations for the team.
 Assist in the evaluation and improvement of departmental SOPs and testing procedures.
 Perform all work using appropriate safety measures.
 Document all laboratory testing and maintain accurate and legible notebooks and records.
 Peer review of data, reports and notebooks.
 Provide input to QC management regarding goals and performance evaluations of team members.
 Assist in special projects or other tasks as deemed necessary based on individual's qualifications,
business needs and QC management’s discretion.

Training or Experience:

 Minimum of 5 years experience in a cGMP laboratory.
 Knowledge of cGMP, USP/NF and FDA Guidelines.
 Excellent oral and written communication skills.
 Able to troubleshoot analytical methods and laboratory instrumentation.
 Working knowledge of Microsoft Word and Excel.
 Experience with Chromatography Data Acquisition Systems and Laboratory Information Systems.
 Demonstrated ability to work as part of a cross-functional team.

Education:

 Degree in Chemistry or related field. Relevant experience may be substituted in lieu of degree.

Supervises/Manages:

 Coordinates daily testing activities and leads other analysts/team members on his/her team.