Production Manager - Vaccine Manufacturing/ Aseptic Manufacturing

Responsible for Aseptic Manufacturing/Vaccine Manufacturing (formulation, filling & packaging) operations. This position works closely with Quality Assurance, Quality Control, Engineering and other relevant teams at site.



ESSENTIAL DUTIES & RESPONSIBILITIES:

• Responsible for all operations of Aseptic Manufacturing

• Ensure oversight of Aseptic Manufacturing operations across all shifts, including weekend support as needed.

• Completion of internal batch record review.

• Client support / interaction related to these processes.

• Assist with the authoring and implementation of manufacturing procedures and batch records.

• Lead routine manufacturing activities; including day to day scheduling and raw

materials/consumables management

• Accurately document data and complete batch records as needed.

• Successfully complete facility's gowning and media fill qualification program.

• Perform and train other employees in various manufacturing tasks, including, but not limited to:

Component Preparation, Formulation Operations, Lyophilization Processes, Sterile Filling, Packaging etc.

• Operate and assist with the maintenance of production equipment.

• Perform duties in cleanroom areas and help to maintain those areas.

• Ensure personnel are trained on all applicable procedures and master batch records prior to execution.

• Initiate revisions to cGMP procedures, and master batch records.

• Assist in the scheduling and performance of routine maintenance and calibration of production equipment.

• Perform Manufacturing review in support of continuous improvements, including:

o Procedures

o Master Batch Records

o Standard Work Instructions

o Risk Assessment Reports

o Training

• Perform all other tasks, projects, and duties as assigned.