Manager, Upstream Operations, mAb products (Night Shift)

Pfizer • Sanford, NC

103d • $102,900 - $171,500

About The Position

The Manager 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 Manager is to optimize resources to maximize production and ensure quality and safety standards.

Requirements

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience.
• A robust grasp of industry knowledge and business operations, such as financial basics, enterprise systems like payroll and inventory management.
• Proficiency in administrative, managerial, and technical report writing skills.
• Effective written and oral communication skills.
• Strong computer and presentation capabilities.
• Experience in people management.
• Knowledge of GMP and regulatory requirements.

Nice To Haves

• Master's degree coupled with relevant pharmaceutical experience.
• Certifications in Continuous Improvement or Project Management.
• Familiarity with Local Environmental Health and Safety standards.
• Excellent interpersonal and communication skills.
• Experience in motivating and developing team members.
• Strong leadership and decision-making skills.
• In depth knowledge of Upstream/Cell Culture unit operations.
• Experience with production equipment and related procedures.
• Experience in process improvement and innovation.
• Previous Leadership, Supervisory or management experience.

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 and identify, evaluate, and correct potential hazards in the workplace.
• Coordinate, schedule & participate in daily activities of cGMP production in the manufacturing area to meet supply chain needs.
• 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.
• Interact daily with all members of their team and cross-functional teams and external vendors as required.
• Participate in inspections and cGMP & Quality decisions affecting short term production.
• Provide supervision to hourly direct reports and motivate personnel by setting high standards and encouraging teamwork.
• Review completed batch records and 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.

Benefits

• 401(k) plan with Pfizer Matching Contributions.
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree