Description: The Group Leader is responsible for leading the manufacturing process of batches. In addition, the Group Leader will perform and demonstrate the actual methods and procedures to produce the products utilizing state of the art processing systems. These systems include sophisticated recipe-controlled human machine interface (HMI) control systems. Essential Functions: + Provide guidance to operators during execution of batches and equipment qualifications. + Resolve manufacturing issues as they arise and escalate to Supervisor. + Participate in equipment set-up, IQ/OQ/PQ, and commercial batch activities. + Set-up, run and clean equipment in a cGMP compliant environment. + Process batches for products including: weighs material, executes batch record, moves/cleans/preps equipment. + Troubleshoot manufacturing machines and make physical adjustments to equipment in order to address manufacturing/packaging issues during production. + Execute commercial validation batches. Additional Responsibilities: + Complies with all company policies and standards. + Conduct manufacturing of R&D ANDA batches and R&D scale-up batches. Perform Continuous improvements. + Participates with operator training.