ROLE SUMMARY
Ensure a safe work environment. Ability to identify, evaluate, and correct potential hazards in the workplace is essential.
• Coordinate, schedule, and 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, and integrated utilities to identify and resolve quality risk to commercial manufacturing. General knowledge of scientific principles, production equipment and related procedures.
• Aid in investigations. Responsible for the adherence to established policies, procedures, and practices. Participate in inspections and cGMP and 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 and personnel reviews. Make initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, Emergency situations, including injured employees, facility issues, and 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 and 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.
ROLE RESPONSIBILITIES
- 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 main goal of the supervisor is to optimize resources to maximize production and ensure quality and safety standards.
- Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
- Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise, and coach their teams.
EDUCATION OR EQUIVALENT
- Bachelor's Degree in Engineering, Business or Science with a minimum of 3+ years of experience and 1+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment
- Associates Degree with a minimum of 5+ years of experience and 3+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment
- High School Diploma with a minimum 7+ years of experience and 5+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment
TECHNICAL/BEHAVORIAL REQUIREMENTS
- Mathematical calculations
- Working knowledge of vaccine or biotechnology product manufacturing in a cGMP environment. Including a working knowledge of fermentation, purification, centrifugation, homogenization, Ultrafiltration and Diafiltration (UF/DF), aseptic techniques and other filtration processes.
- Optimize resources to maximize production and ensure quality and safety standards.
- Ensures that work performed by the assigned staff is accurate, timely, efficient, and compliant with corporate policies, plant SOPs, cGMP regulations,and FDA regulations.
- Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
- Effectively monitor the actions of their team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities.
- Be accountable for the Good Data Management and Data Integrity understanding and performance of their team.
- Be available to their direct reports for real time escalations of any concerns or support needs.
- Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
- Lead and support continuous improvement efforts, where applicable.
- Be a role model to support a positive compliance culture.
- Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
12-hour (6am-6pm) day shift schedule (2 on, 2 off, 3 on). Works every other weekend.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
12-hour day shift position (6am-6pm) 2-2-3 schedule. Works every other weekend.
Works in a clean room environment with gowning requirements.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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.
Manufacturing
#LI-PFE