Manufacturing Supervisor (2nd Shift)

About this opportunity :

As a Manufacturing Supervisor, you are responsible for the implementation and execution of production procedures and processes with the goal of optimizing the manufacturing process while meeting regulatory requirements.  You will assist development personnel in developing new, scalable processes and procedures which improve product yield and reduce manufacturing costs. This is a 2nd shift position which runs from M-F 3:00pm-11:30pm with a 15% shift differential.

Key Job Responsibilities:

• Maintain a safe working environment and follow all site safety procedures. Perform daily Gemba walks to ensure compliance to safety and quality standards. 
• Assist in the development of new processes and procedures.
• Operate and perform routine maintenance on equipment used. Perform troubleshooting when expected results are not achieved. 
• Oversee activities of line supervisors and technical support staff. Provide SME support when challenges arise in the MFG area. Responsible for assigning qualified lead resources to each unit operation. 
• Responsible for performing all work within Company and cGMP regulatory guidelines for quality, safety, and environment.
• Develop production procedures and processes to improve the product yield and reduce manufacturing costs of current processes.
• Monitor departmental objectives and schedules including setting priorities and performance expectations for all staff 
• Review executed GMP documentation and ensure RFT execution.
• Provide for the effective recruitment and development of staff in accordance with company policies and programs. Provide coaching and mentoring of MFG technicians.
• Develop skills to act as SAP SME for the MFG department. Gain an understanding of SAP as it relates to MFG activity. Become proficient in all MFG related SAP transactions. 

 
Job Knowledge Required:

• BS Degree in Chemistry or equivalent combination of education and experience.
• 5+ years of experience in clinical or commercial API production. 
• Knowledge of chemical handling and basic lab safety required. Experience in cGMP setting preferred.
• Must be able to accurately collect and evaluate data to make judgments on the validity of the results achieved.
• Required to evaluate whether cGMP requirements are being met at all times and if not, to take appropriate action.
• Ability to innovatively solve problems.
• Excellent verbal and written communication are required.