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Manager, Upstream Operations, mAb products (Night Shift)

Manager, Upstream Operations, mAb products (Night Shift)

PfizerSanford, NC, US
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Use Your Power For Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

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.

What You Will Achieve

In this role, you will :

  • 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. 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.

Here Is What You Need (Minimum 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
  • Bonus Points If You Have (Preferred Requirements)

  • 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 is preferred.
  • Physical / Mental Requirements

  • Moderate repetitive standing, sitting, bending, ladder climbing, pushing and lifting (up to 40lbs) required on a daily basis.
  • Ability to perform mathematical calculations and learn new processes / systems.
  • Strong problem-solving skills and the ability to manage complex projects.
  • Ability to work collaboratively with cross-functional teams.
  • Strong leadership and collaboration capabilities.
  • Aseptic gowning required on production floor.
  • Non-Standard Work Schedule, Travel or Environment Requirements

  • This role is a 12 hour night shift (6pm to 6am) on a 2 / 2 / 3 rotating schedule.
  • Work Location Assignment : On Premise

    Last date to apply : 10 / 6 / 2025

    The annual base salary for this position ranges from $102,900.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver / parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

    Relocation assistance may be available based on business needs and / or eligibility.

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    Operation Manager • Sanford, NC, US

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