WHY PATIENTS NEED YOU
Under the general guidance of the Sr Manager, the Team Lead, in conjunction with their peers, you will serve as the first line manager within the operational areas of the site.
WHAT YOU WILL ACHIEVE
You will direct multi-shift work activities of hourly colleague in an assigned operational area of the site to include the filling, inspection, packaging, assembly and storage of active pharmaceutical ingredients (API), parenteral liquid drug products and auto-injector medical devices.
You will be responsible for supervising both manual and automated processes within and/or outside aseptic environments.
HOW YOU WILL ACHIEVE IT
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, IDPs).
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, 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 reduce waste through the application of OpEx and 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.
Maintains and improves labor standards as it relates to having the proper number of colleagues assigned to each line per the line standards to meet staffing and financial guidelines.
Champions a safety culture by aiding in the establishment of safety rules and instruction. Adheres to safety requirements. Reports events to 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, visual inspection 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.
QUALIFICATIONS
Must-Have
Applicant must have a bachelor's degree with at least 3+ years of experience; OR a master's degree with more than 1+ year 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.
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 6+ years of experience and 3+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.
High School Diploma with a minimum 8+ years of experience and 5+ years demonstrated leadership capability in a pharmaceutical and/or manufacturing environment.
A strong personal motivation and aptitude for coaching, leading and managing individuals and teams.
An aptitude for…