Team Lead, Aseptic Preparation (3rd shift)
About The Position
This position is a 3rd shift team leader for the Drug Product Organization in the Aseptic Preparation area. Under the general guidance of the Sr Manager, the Team Lead, in conjunction with their peers, will serve as the first line manager within the operational areas of the site. They will be responsible for leadership of cleaning and sanitizing equipment and materials needed for aseptic filling, in support of Drug Product Injectable Operations. In this role, you will: Supervise colleague work activities in the production of Injectable Drug Products in compliance with current Good Manufacturing Practices (cGMP) as well as all federal, state, and local environmental and safety regulations. Actively engage in colleague development, including timely performance feedback/appraisals as well as through other aspects of the performance management process (i.e. 1:1s, performance plans). Ensure colleague training is maintained and in compliance with appropriate procedures, specifications and standards. Assist in ensuring units are manufactured to forecasted volume with the appropriate resources. Schedules staffing, optimizing labor available to meet required product demands of customers within budgeted guidelines, communicating with and recommending actions to leadership as needed. Collaborates cross-functionally with Quality, Maintenance, Automation, Warehouse and other production personnel to ensure information is properly shared and production remains on schedule. Completes operational quality, environmental, and safety incident investigations as required. Actively partners with others, sharing knowledge, problem solving, and implementing solutions to issues on the manufacturing floor. Identifies process improvements and supports continuous improvement initiatives related to compliance, safety and production to minimize risk, ensure product quality and reduction in waste through the application of IMEx principles. Anticipates and reacts to shortages of material, equipment, personnel, and space to meet schedule and maintain inventory. Reviews batch records, supports release of production lots and ensures product meets quality and quantity standards. Champions a safety culture by aiding in the establishment of JHAs and SWPs and completes safety Gembas. Adheres to safety requirements. Reports events to leadership and EH&S. Ensures events are contained and appropriate steps are taken to mitigate risk to product and the manufacturing environment. Provides continuous GMP coaching (i.e. aseptic practices, GDP, process step sequence adherence, etc.) to ensure procedures and policies are followed and ensure the quality of the product. Assists manager with special projects and other duties as assigned or needed.
Requirements
- Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
- A strong personal motivation and aptitude for coaching, leading and managing individuals and teams.
- An aptitude for understanding process technology and equipment, proven leadership ability, decision making ability, and excellent oral and written communication skills are essential.
- Demonstrated ability to interact effectively with all levels of the organization.
- Candidate must possess flexibility to respond to constantly changing conditions and priorities.
Nice To Haves
- Previous leadership experience preferred.
Responsibilities
- Supervise colleague work activities in the production of Injectable Drug Products in compliance with current Good Manufacturing Practices (cGMP) as well as all federal, state, and local environmental and safety regulations.
- Actively engage in colleague development, including timely performance feedback/appraisals as well as through other aspects of the performance management process (i.e. 1:1s, performance plans).
- Ensure colleague training is maintained and in compliance with appropriate procedures, specifications and standards.
- Assist in ensuring units are manufactured to forecasted volume with the appropriate resources.
- Schedules staffing, optimizing labor available to meet required product demands of customers within budgeted guidelines, communicating with and recommending actions to leadership as needed.
- Collaborates cross-functionally with Quality, Maintenance, Automation, Warehouse and other production personnel to ensure information is properly shared and production remains on schedule.
- Completes operational quality, environmental, and safety incident investigations as required.
- Actively partners with others, sharing knowledge, problem solving, and implementing solutions to issues on the manufacturing floor.
- Identifies process improvements and supports continuous improvement initiatives related to compliance, safety and production to minimize risk, ensure product quality and reduction in waste through the application of IMEx principles.
- Anticipates and reacts to shortages of material, equipment, personnel, and space to meet schedule and maintain inventory.
- Reviews batch records, supports release of production lots and ensures product meets quality and quantity standards.
- Champions a safety culture by aiding in the establishment of JHAs and SWPs and completes safety Gembas.
- Adheres to safety requirements. Reports events to leadership and EH&S. Ensures events are contained and appropriate steps are taken to mitigate risk to product and the manufacturing environment.
- Provides continuous GMP coaching (i.e. aseptic practices, GDP, process step sequence adherence, etc.) to ensure procedures and policies are followed and ensure the quality of the product.
- Assists manager with special projects and other duties as assigned or needed.
Benefits
- 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
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Manager
