Supervises operations employees of high quality pharmaceutical products according to schedule, cost and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement, accountability, and creating a climate where staff are motivated to do their best.
Supervises employees in day to day operations by spending at least 50% of available time interfacing with employees to ensure that every product unit is of high quality and exceeds all the Company’s current Good Manufacturing Practices (cGMPs).
Ensures that production schedule is met by distributing workload in accordance with changing priorities.
Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility.
Prepares performance reviews for all employees and evaluates personnel performance according to performance management process. Provides feedback for continuous improvement. Holds staff accountable and applies discipline process as required. Assists in hiring staff as needed. Maintains a work environment with fosters teamwork and supports the company’s continuous improvement process.
Evaluates/solves operation problems by reviewing the area of concern, developing potential solutions, technically evaluating or testing the solutions, and preparing summary reports/recommendations for management.
Supports the company’s safety program to maximize safety awareness and provides a safe work environment. Ensures responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements.
Performs other duties as assigned.
Provides tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules. Erroneous decisions or failure to achieve goals may cause schedule delays.
Provides direct supervision and may assist with the work as demands dictate.
BS/BA degree in Engineering, STEM related program, or relevant field of study.
Four years of technical and/or manufacturing experience. One to five years of supervisory experience preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Technical and operational knowledge of aseptic processing operations, ability to handle multiple ongoing activities, and ability to prioritize tasks. Position is the key interaction with customers in commercial operation of the described lines. Effective written, verbal, and interpersonal skills. Must be able to work in a fast-paced environment with demonstrated ability to prioritize and be self-directed. Ability to coordinate multiple activities while maintaining a high level of accuracy. Attention to detail. Ability to collaborate effectively with others to achieve goals and expectations.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office, manufacturing, and warehouse locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.