Group Leader, Manufacturing

Job Summary

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.

Education

• High School or GED - Required

Work Experience

• 3 years or more in Pharmaceutical, Manufacturing - Required

Skills and Abilities

• Superior communication,  both verbal and written instructions. - Intermediate
• Demonstrated ability to train and coach manufacturing operators - Intermediate
• Strong attention to detail. - Intermediate
• Demonstrated time management and multitasking - Advanced
• Strong leadership and interpersonal skills. - Intermediate
• Proficient in MS office suit. - Intermediate

Specialized Knowledge

• Knowledge of safety, cGMP and SOP, quality systems and quality assurance concepts, 21 CFR Parts 210 and 211.
• Knowledge of equipments with containment techniques. Hands on experience with Topical manufacturing equipment such as Becomix, Ross mixer, HMI systems, tube and bottle filling machine, packaging equipment, ancillary equipment.