Supervisor, Downstream Operations, mAb Products (Days 6am - 6pm)

Pfizer • Sanford, NC

4d • Onsite

About The Position

The Supervisor is accountable and responsible for leading assigned production staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer service. Responsible for planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees typically with similar technical responsibilities. Ensures that work performed by the assigned staff is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations. Participates in investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and/or cycle time. Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are accurate and complete. Has a basic understanding of product cost structure, budgeting process and spending. The ultimate goal of the supervisor is to optimize resources to maximize production and ensure quality and safety standards.

In this role, you will: Oversee the downstream production of mAb products , 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. Ability to identify, evaluate, and correct potential hazards in the workplace is essential. Coordinate, schedule & participate in daily activities of cGMP production in the manufacturing area to meet supply chain needs. Must be flexible to work rotating shifts to support 24/7 operation. Ensure that product quality is maintained through all phases of commercial production including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics & integrated utilities to identify & resolve quality risk to commercial manufacturing. Role will interact daily with all members of their team. Interaction with the teams entering and exiting before their shift. Role will also interact with cross functional teams and external vendors as required. General knowledge of scientific principles, production equipment & related procedures. Aid in investigations. Responsible for the adherence to established policies, procedures and practices. Participate in inspections and cGMP & Quality decisions effecting short term production Provide supervision to hourly direct reports. Motivate personnel by setting high standards, encourage teamwork. Clear, unambiguous communication is critical. Primary contact for all personnel issues occurring within the department. Responsible for development plans & personnel reviews. Make initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, Emergency situations, including injured employees, facility issues & inclement weather. Review completed batch records. Develop training material, update curricula, close training gaps, support the training of new supervisors. Advise management of non-conformance issues & opportunities for continuous improvement Provide input on primary decisions on cGMP related documents developed or revised. Articulate challenges and solutions to technical and non-technical peers and to department management. Provide technical guidance and act as a departmental liaison with primary support groups. Short range planning includes scheduling daily and weekly operations and staff. Longer range planning concerns facilities shutdowns and preventive maintenance.

Requirements

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Strong people management skills
• Ability to identify, evaluate, and correct potential hazards in the workplace
• Experience in pharmaceutical manufacturing
• Knowledge of current Good Manufacturing Practices (cGMP)
• Proficiency in managing quality, compliance, and customer service
• Strong problem-solving skills and the ability to manage complex projects
• Permanent work authorization in the United States

Nice To Haves

• General knowledge of scientific principles
• In depth knowledge of Downstream Purification unit operations.
• Experience with production equipment and related procedures
• Experience in process improvement and innovation
• Ability to work collaboratively with cross-functional teams
• Strong analytical and decision-making skills
• Strong leadership and collaboration capabilities
• Previous Leadership, Supervisory or management experience is preferred.

Responsibilities

• Leading assigned production staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer service.
• Planning, organizing, staffing, performance assessment, salary recommendations, and employee counseling for a group of employees.
• Ensuring that work performed by the assigned staff is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations.
• Participating in investigations and continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and/or cycle time.
• Collaborating effectively with other functional SMEs to ensure production goals are met and investigations are accurate and complete.
• Optimizing resources to maximize production and ensure quality and safety standards.
• Overseeing the downstream production of mAb products, ensuring targets are met and processes remain consistent.
• Managing quality, compliance, and customer service, including staffing and employee counseling.
• Ensuring team performance is accurate, timely, efficient, and compliant with corporate policies, SOPs, GMPs, and other regulations.
• Leading and coaching production work teams, managing technical resources, and solving complex problems within your expertise.
• Establishing operational activities supporting mid-term goals, recognizing development needs, and creating opportunities for colleagues.
• Coordinating activities for equipment and automation changes, participating in daily manufacturing activities, and ensuring a safe work environment while collaborating with functional SMEs and trainers to meet production goals and training needs.
• Coordinating, scheduling & participating in daily activities of cGMP production in the manufacturing area to meet supply chain needs.
• Ensuring that product quality is maintained through all phases of commercial production including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics & integrated utilities to identify & resolve quality risk to commercial manufacturing.
• Interacting daily with all members of their team, cross-functional teams, and external vendors as required.
• Aiding in investigations.
• Responsible for the adherence to established policies, procedures and practices.
• Participating in inspections and cGMP & Quality decisions affecting short term production.
• Providing supervision to hourly direct reports.
• Motivating personnel by setting high standards and encouraging teamwork.
• Serving as the primary contact for all personnel issues occurring within the department.
• Responsible for development plans & personnel reviews.
• Making initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, emergency situations, including injured employees, facility issues & inclement weather.
• Reviewing completed batch records.
• Developing training material, updating curricula, closing training gaps, and supporting the training of new supervisors.
• Advising management of non-conformance issues & opportunities for continuous improvement.
• Providing input on primary decisions on cGMP related documents developed or revised.
• Articulating challenges and solutions to technical and non-technical peers and to department management.
• Providing technical guidance and acting as a departmental liaison with primary support groups.
• Scheduling daily and weekly operations and staff.
• Planning for facilities shutdowns and preventive maintenance.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED