Manager, Downstream Operations, mAb products en Pfizer
Pfizer · Sanford, Estados Unidos De América · Onsite
- Professional
- Oficina en Sanford
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 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.
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 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
Previous Leadership, Supervisory or management experience
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
Strong leadership and collaboration capabilities
Aseptic gowning required on manufacturing floor
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is a 12 hour day shift (6am to 6pm) on a 2/2/3 rotating schedule
Other Job Details:
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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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