Formulation Supervisor - Third Shift

The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel.

• Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed
• Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss
• Maintain weekly/daily schedule
• Use production schedule and activities, communicate necessary to do tasks to associates and/or leads
• Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment
• Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed
• Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member
• Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes
• Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review
• Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
• Identify safety risks and alerts management to take corrective action
• Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements
• Other duties as assigned
• Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records
• Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements
• Assign and direct work, provide direction, resources and resolve problems
• Participate in recruiting
• Provide feedback on performance to Formulation Manager
• Train team members and ensures proper training is completed prior to assigning tasks
• Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products

Experience:

• Two (2) to three (3) years’ work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same
• Leadership experience as a team lead or supervisor type role preferred
• Bachelor’s degree preferred
• An equivalent combination of education and experience may be considered