Nature and Scope

This position is responsible for managing and leading the day-to-day manufacturing processes associated with commercial aseptic manufacturing of safe, effective, and sterile pharmaceuticals. The scope of the position includes overseeing various departments, such as Compounding, Equipment/Component Preparation, Sterile Filling, Inspection, and Packaging.

The Production Supervisor oversees all aspects of the Manufacturing Process, including component preparation, aseptic cleaning, compounding, filtration, and filling. They are responsible for signatory approval of all activities associated with the manufacturing process and providing direction, training, and mentorship to junior team members when needed. This position requires the supervisor to assist in troubleshooting, making adjustments, and conducting minor repairs during setup and operations.

The Supervisor provides leadership to achieve product quality, cost control, cGMP compliance, safety, and adherence to production schedules, supporting customer service objectives. Daily oversight ensures departmental compliance with company SOPs, data integrity for all GMP processes, and meeting department-specific requirements. The supervisor ensures compliance with all regulatory requirements, including FDA, OSHA, OFCCP, EPA, etc.

The Manufacturing Team ensures that all activities align with company SOPs, policies, and cGMPs. Aseptic and sanitary conditions are maintained as required, and manufacturing area and equipment records are kept accurate. The team plays a critical role in maintaining production schedules, meeting company goals, and providing input and assistance to other departments under the supervision of Production Management.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

·       Direct shop floor supervision, batch record execution, SOP training, manufacturing investigation reports, and employee payroll, while participating in process improvement activities.

·       Supervise daily manufacturing operations across departments and make staffing decisions.

·       Schedule and direct production personnel to operate the production lines as per the schedule.

·       Achieve production performance objectives by delivering quality products in a timely and cost-efficient manner.

·       Prioritize and allocate resources to meet annual operating plan and budgetary commitments.

·       Hire, train, and evaluate employees' job performance, working with subordinates to further their skills and development.

·       Ensure accuracy and timeliness of all batch paperwork according to Good Documentation Practices.

·       Oversee cleaning of production areas as per procedures and schedules.

·       Monitor safety and take corrective actions to eliminate hazardous situations.

·       Address and coordinate problems with relevant departments and bring quality issues to management attention.

·       Conduct investigations of process deviations and compile technical documentation.

·       Develop technical documents, including Standard Operating Procedures (SOPs), Product/Process Specification Documents (PPSs), Manufacturing batch records (MBRs), and production training records.

·       Support employee feedback and developmental processes.

·       Emphasize safety and quality commitments within the department.

·       Investigate and resolve disciplinary issues, up to and including suspensions and terminations.

·       Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

·       Associate degree, B.A. or B.S degree preferred.

·       Minimum 3 years of previous supervisory experience in a GMP regulated industry or 1 to 3 years of leadership experience.

·       Experience in manufacturing, the pharmaceutical industry, or with GMP/FDA regulations is a plus.

·       Aseptic manufacturing, Isolator technology, and cleanroom experience preferred.

·       Strong oral and written communication skills.

·       Strong time management, organizational, and project management skills.

·       Experience writing, reviewing, and executing standard operating procedures preferred.

·       Knowledge of MS Applications (Word/Excel/Outlook/Power Point).

·       Must be able to read documents in Standard English, such as Standard Operating Procedures, maintenance schedules, and operating manuals.

·       Chemical handling, mathematical aptitude, and the ability to troubleshoot and perform minor repairs on manufacturing equipment is preferred.

Physical Environment and Requirements

·  Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.  PPE and Respirators are essential for the health and safety of employees.

·  Employee must be able to occasionally lift and/or move up to 50 pounds.

Expected Salary Range:

$91,000 - $100,000

The salary range, displayed is the  minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.  Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.