Supervisor, Upstream mAbs (Nightshift)

Role Summary

The Supervisor leads assigned upstream production staff to achieve targets and improve process or product quality, compliance, cost standards, and customer service. Responsibilities include planning, organizing, staffing, performance assessment, and employee development to ensure work is accurate, timely, efficient, and compliant with corporate policies, SOPs, cGMP, and FDA regulations.

Responsibilities

• Oversee the upstream production of mAb products, including media prep, ensuring targets are met and processes remain consistent.
• Manage quality, compliance, and customer service, including staffing and employee counseling.
• Ensure team performance is accurate, timely, efficient, and compliant with corporate policies, SOPs, GMPs, and other regulations.
• Optimize resources to maximize production while maintaining quality and safety standards.
• Lead and coach production work teams, manage technical resources, and solve complex problems within your expertise.
• Establish operational activities supporting mid-term goals, recognize development needs, and create opportunities for colleagues.
• Coordinate activities for equipment and automation changes, participate in daily manufacturing activities, and ensure a safe work environment while collaborating with functional SMEs and trainers to meet production goals and training needs.
• Ensure a safe work environment. Identify, evaluate, and correct potential hazards in the workplace.
• Coordinate, schedule, and participate in daily activities of cGMP production in the manufacturing area to meet supply chain needs.
• Be flexible to work rotating shifts to support 24/7 operation, maintaining product quality through all phases of commercial production.
• Interact daily with team members and cross-functional teams, including external vendors, as required.
• Apply general knowledge of scientific principles, production equipment, and related procedures.
• Aid in investigations and participate in inspections and cGMP/Quality decisions affecting short-term production.
• Provide supervision to hourly direct reports, motivate personnel, and maintain clear, unambiguous communication.
• Act as primary contact for personnel issues within the department, handling development plans, performance reviews, and emergency situations.
• Review completed batch records, develop training materials, update curricula, close training gaps, and support training of new supervisors.
• Advise management of non-conformance issues and opportunities for continuous improvement.
• Provide input on cGMP-related documents and communicate challenges and solutions to peers and management.
• Provide technical guidance and act as a departmental liaison with primary support groups.
• Short-range planning includes scheduling daily and weekly operations; longer-range planning covers facilities shutdowns and preventive maintenance.

Qualifications

• Required: High school diploma (or equivalent) with 8+ years of experience, or associate’s degree with 6+ years, or BA/BS with 2+ years, or MBA/MS with any relevant experience.
• Required: Strong people management skills.
• Required: Ability to identify, evaluate, and correct potential hazards in the workplace.
• Required: Experience in pharmaceutical manufacturing or a related field.
• Required: Knowledge of current Good Manufacturing Practices (cGMP).
• Required: Proficiency in managing quality, compliance, and customer service.
• Required: Strong problem-solving skills and ability to manage complex projects.
• Preferred: General knowledge of scientific principles.
• Preferred: In-depth knowledge of Upstream/Cell Culture unit operations.
• Preferred: Experience with production equipment and related procedures.
• Preferred: Experience in process improvement and innovation.
• Preferred: Ability to work collaboratively with cross-functional teams.
• Preferred: Strong analytical and decision-making skills.
• Preferred: Strong leadership and collaboration capabilities.
• Preferred: Previous leadership, supervisory, or management experience.

Skills

• People management
• Quality, compliance, and customer service management
• cGMP knowledge
• Problem-solving and project management
• Communication and coaching
• Cross-functional collaboration

Additional Requirements

• Physical/Mental: Moderate repetitive standing, sitting, bending, ladder climbing, pushing and lifting up to 40 lbs daily.
• Non-standard Work Schedule: 24/7 (12-hour) rotating night shifts with overtime; aseptic gowning on the production floor.