Team Lead, APN Filling (3rd Shift) (Secondment 6-9 Months)

Pfizer•Kalamazoo, MI

About The Position

Under the general guidance of the Senior Manager, the Team Lead serves as a first-line manager within a site operational area, working in conjunction with peers. The role directs multi-shift activities of hourly colleagues involved in filling, inspection, packaging, assembly, and storage of active pharmaceutical ingredients, parenteral liquid drug products, and auto-injector medical devices. The Team Lead supervises manual and automated processes in and outside aseptic environments. The position oversees production of injectable drug products in compliance with current Good Manufacturing Practices and applicable environmental and safety regulations. It involves colleague development and training, staffing and resource planning, cross-functional coordination, investigation of quality, environmental, and safety incidents, continuous improvement, production schedule and inventory management, batch record review, and support for production lot release. The role also promotes safety and GMP compliance through coaching and operational oversight. This is a 6–9 month secondment requiring at least 40 hours per week. The schedule may include traditional or split shifts, weekends, holidays, and overtime as needed. Travel between facilities may be required. The work involves production areas, moving machinery, temperature changes, and required PPE; maintaining aseptic area certification and following aseptic gowning procedures are required. The work location will not change, and relocation is not offered for this role.

Requirements

Bachelor’s degree with at least 3 years of experience; or master’s degree with more than 1 year of experience; or associate degree with 6 years of experience; or high school diploma or equivalent with 8 or more years of relevant experience.
Bachelor’s degree in Engineering, Business, or Science with at least 3 years of experience and at least 1 year of demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.
Associate degree with at least 6 years of experience and at least 3 years of demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.
High school diploma with at least 8 years of experience and at least 5 years of demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.
Strong personal motivation and aptitude for coaching, leading, and managing individuals and teams.
Aptitude for understanding process technology and equipment.
Proven leadership and decision-making ability.
Excellent oral and written communication skills.
Ability to interact effectively with all levels of the organization.
Flexibility to respond to changing conditions and priorities.
Ability to stand upright for several consecutive hours, absent medical restrictions that would prevent required duties.
Ability to stand and frequently walk between production centers or areas to supervise operations.
Ability to perform occasional bending, stooping, squatting, carrying, and lifting up to 25 pounds.
Close vision, color vision, and ability to adjust and focus.
Ability to work around moving machines and temperature changes and wear required personal protective equipment.
Ability to work at least 40 hours per week, and to work traditional or split shifts, weekends, holidays, and overtime as needed.
Ability to travel between facilities when necessary.
Ability to maintain aseptic area certification, including aseptic gowning that fully covers all body parts for substantial periods.
Permanent authorization to work in the United States; work visa sponsorship is not available.

Nice To Haves

Previous leadership experience preferred.

Responsibilities

Direct multi-shift work activities of hourly colleagues in an assigned operational area, including filling, inspection, packaging, assembly, and storage operations.
Supervise manual and automated production processes in and outside aseptic environments.
Oversee injectable drug product production in compliance with cGMP and applicable environmental and safety regulations.
Develop colleagues through timely performance feedback, appraisals, one-on-ones, individual development plans, and other performance management activities.
Ensure colleague training is maintained and complies with applicable procedures, specifications, and standards.
Help ensure units are manufactured to forecasted volume with appropriate resources.
Schedule staffing and optimize available labor to meet customer product demands within budget guidelines; communicate and recommend actions to leadership as needed.
Collaborate with Quality, Maintenance, Warehouse, and production personnel to share information and keep production on schedule.
Complete operational quality, environmental, and safety incident investigations as required.
Partner with others to share knowledge, solve problems, and implement solutions on the manufacturing floor.
Identify process improvements and support continuous improvement initiatives related to compliance, safety, and production, applying OpEx and IMEx principles to minimize risk, ensure product quality, and reduce waste.
Anticipate and respond to shortages of materials, equipment, personnel, and space to meet schedules and maintain inventory.
Review batch records, support production lot release, and ensure products meet quality and quantity standards.
Maintain and improve labor standards by ensuring the appropriate number of colleagues are assigned to each line in accordance with line standards and staffing and financial guidelines.
Promote a safety culture by helping establish safety rules and instruction, following safety requirements, reporting events to EH&S, and ensuring events are contained and risks to product and the manufacturing environment are mitigated.
Provide ongoing GMP coaching, including coaching on aseptic practices, GDP, and visual inspection sequence adherence.
Assist the manager with special projects and other duties as assigned or needed.
Work traditional or split shifts, weekends, holidays, and overtime as needed to manage operations and complete production documentation and schedules.
Travel between facilities when necessary.
Maintain aseptic area certification and comply with required aseptic gowning procedures and PPE requirements.