Process Supervisor of Manufacturing (7am-3:30pm)
American Regent, Inc.
Summary
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 includes overseeing Compounding, Equipment/Component Preparation, Sterile Filling, Inspection, and Packaging.
Job description
Essential Duties and Responsibilities
- 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.
Education Requirements and Qualifications
- 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.
- Employee must be able to occasionally lift and/or move up to 50 pounds.
Requirements
- 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
- Chemical handling, mathematical aptitude, and the ability to troubleshoot and perform minor repairs on manufacturing equipment is preferred
- Physically able to wear cleanroom/protective gowning and equipment
- Employee must be able to occasionally lift and/or move up to 50 pounds
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
Company overview
American Regent, Inc. is a leading U.S.-based pharmaceutical company and a member of the Daiichi Sankyo Group, specializing in the development, manufacturing, and supply of high-quality sterile injectables. Founded in 1967, the company has grown from small beginnings to become a major player in the pharmaceutical manufacturing sector, with a particular focus on IV iron therapy where it has been a market leader for over 25 years. The company operates manufacturing facilities in New York, Ohio, and Pennsylvania, serving healthcare providers, clinics, and hospitals across the United States and Canada. American Regent's portfolio includes both branded and generic injectable products, with notable offerings in animal health through its American Regent Animal Health division, which provides leading joint health treatments for horses and dogs. The company is committed to U.S.-based manufacturing and has made significant investments in modernizing and expanding its production capabilities to ensure reliable supply and responsiveness to market needs.