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Form of workAbout the Company
Our client is a premier, global Contract Manufacturing and Development Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, they deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of their 1,000 plus members across three continents is focused on utilizing their collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes.
About the Role
The Sr. Production Supervisor provides day-to-day leadership and direction for the production team in the manufacturing department to ensure GMP compliance and excellence in execution and product quality. You’ll appropriately allocate resources and production personnel to achieve on time delivery of the manufacturing schedule and actively coach production personnel on GMP compliance and GDP documentation. The person in this role reviews MBRs, logbooks, and champions an environment of safety, innovation, continuous improvement, quality, and compliance. And you’ll collaborate with Quality on investigations and the writing of NCRs, deviations, and CAPAs. This position is an on-site position based at the company’s St. Paul, MN facility, and will report to the Production Manager. As a Senior Supervisor and senior leader of the manufacturing teams, the position’s direct manager may or may not be on the same shift schedule.
Responsibilities
• Coordinate with production planners and production management to schedule and coordinate manufacturing activities to meet customer (internal and external) timelines and expectations
• Ensure a positive approach to employee relations for all employees; maintain effective lines of communication with employees, leads, and peers; resolve employee issues through established channels
• Ensure manufacturing processes and resources are utilized in a reliable, effective and efficient manner
• Manage the successful transition of new products and technology into the production area
• Lead by example by being an on-floor presence for the manufacturing team to actively coach and assist with training of production personnel on GDP & GMPs
• Aid quality with non-conformance and CAPA investigations related to production; properly utilize root cause analysis tools; write clearly and concisely, and work collaboratively to meet CAPA/NCR timelines
• Effectively collaborate with cross functional teams (Quality, Engineering, Project Management, R&D) to drive 100% training compliance
• Demonstrate hands-on leadership in the culture of accountability and adherence to current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), including the review of in-process batch records, forms, and logbooks
• Ensure manufacturing production is compliant with FDA regulations and internal Standard Operating Procedures (SOPs; collaborate with the manufacturing team to generate feedback for SOP and work instruction revisions as necessary
• Ensure safety is a priority to all employees
• Participate in internal/external audits and help to address and findings related to production
• Review and approve time sheets and ensure transmittal of information to Payroll in a timely manner to ensure payment of personnel and recording of job costs
• Conduct performance reviews, assisting with staffing changes, hires, employee coaching, and terminations
• Champion the company’s key behaviors of teamwork, leadership, entrepreneurship, accountability, and customer orientation to ensure the organization’s effectiveness and success
• All other duties as assigned
Education and Experience
• High School diploma or equivalent required; Bachelor’s degree in engineering, operations or business preferred
• 7+ years’ prior experience working in pharmaceutical or medical device industry required
• 4+ years’ supervisory/leadership experience required
• Proficiency in Microsoft Excel, Word, PowerPoint, and functional knowledge of MRP systems
