Supervisor, Manufacturing – Albumin Bulk

• Oversee the manufacturing process and department personnel on a designated shift
• Ensure processes meet cGMP and company standards for aseptic operations
• Train and develop department technicians
• Supervise employees, assign tasks, check work, and maintain schedules
• Review department batch documentation for completeness and accuracy
• Initiate facility work orders when equipment requires repair
• Troubleshoot processes and products to maintain aseptic processing, product yields, and facility environmental controls
• Recommend and implement improvements to production methods, equipment performance, facility layout, and product quality
• Ensure compliance with regulatory requirements and maintain knowledge of regulatory and industry standards
• Prepare investigation reports for out-of-specification results and out-of-procedure events
• Participate in regulatory and internal inspections/audits and provide written responses
• Guide and provide hands-on training to direct reports
• Appraise and monitor employee performance
• Coach, counsel, address complaints, and resolve employee issues with Human Resources
• Promote employee health and safety
• Participate in interviewing and selecting personnel for hiring or promotion

• Associate’s degree required
• Bachelor’s degree preferred
• Emphasis in Biology, Chemistry, Chemical Engineering, or a closely related scientific/technical discipline preferred
• Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA-regulated environment
• In lieu of an Associate's degree, high school diploma or GED and a minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA-regulated environment
• In-depth understanding of pharmaceutical manufacturing operations, including protein purification and aseptic processing
• Comprehensive knowledge of cGMPs, FDA regulations, and industry guidelines
• Prior supervisory or leadership experience highly preferred
• Leadership skills to motivate, guide, train, coach, and develop department personnel
• Project management skills
• Strong organizational, analytical, and problem-solving skills
• Ability to prioritize and manage multiple tasks to meet deadlines
• Strong interpersonal skills for interaction with personnel at all levels in a team environment
• Excellent verbal and written communication skills in English
• Computer literacy and proficiency in MS Office, including Outlook, Word, Excel, and Power Point
• Flexibility with working hours/shifts for 24-hour, 7-day plant operations
• Ability to work in environments involving biological fluids, infectious organisms, extreme cold, chemicals, moving machinery, and high noise
• Ability to use required personal protective equipment
• Ability to lift and carry up to 35 lbs
• Ability to travel occasionally within the United States
• Ability to communicate complex information, work independently, interact with diverse groups, and obtain consensus on issues

Demonstrates expertise in overseeing pharmaceutical manufacturing processes while ensuring compliance with cGMP and FDA regulations. Capable of training and developing personnel, managing production methods, and maintaining high standards of product quality and safety.

• CGMP Compliance
• Pharmaceutical Manufacturing Operations
• Aseptic Processing
• Leadership Skills
• Project Management

• Protein Purification
• Regulatory Knowledge
• Batch Documentation Review
• Troubleshooting Processes
• Investigation Reporting

• Strong Interpersonal Skills
• Analytical Skills
• Problem-Solving Skills
• Organizational Skills
• Communication Skills

• FDA Regulations
• Pharmaceutical Industry
• GMP Environment
• Aseptic Operations
• Employee Training

• MS Office Suite
• Personal Protective Equipment