Manufacturing Formulation Supervisor

Position Summary

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.

Duties and Responsibilities

• 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

Regulatory Responsibilities

• 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

Supervisory Responsibilities

• 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

Experience

• Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products
• 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 of supervisor type role preferred

Education

• Bachelor's degree preferred
• An equivalent combination of education and experience may be considered

Knowledge, Skills & Abilities

• Possess working knowledge of formulation/compounding processes and equipment
• cGMP and cGLP practices
• Experience with Microsoft Office and general computer proficiency
• Attention to detail
• Able to follow rules and regulations
• Mechanical aptitude
• Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
• Honesty, integrity, respect and courtesy with leadership and peers
• Ability to build collaborative relationships
• Supervisory skills
• Conflict resolution
• Able to perform complex work instructions and trouble shoot complex problems

• Able to meet gowning requirements
• Visual acuity
• Fine and gross motor skills to manipulate tools and equipment
• Able to remain stationary for continuous prolonged periods of time
• Able to lift 30lbs repeatedly
• Able to wear PPE
• Able to be medically qualified to participate in respirator program
• Able to use standard office equipment with or without reasonable accommodation