Nature and Scope

This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, appropriate manufacturing area and equipment records are neat and accurate and safe, effective, and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Production Supervisor will be able to oversee all aspects of the Manufacturing Process. The Manufacturing Process includes component prep, aseptic cleaning, compounding, filtration, and filling in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals. The Production Supervisor will be able to perform, oversee and provide signatory approval for all activities associated with the manufacturing process. The Production Supervisor will be able to provide direction, training and mentorship to all junior team members as needed. The Production Supervisor will be the responsible person for the proper use of batch documentation. The Production Supervisor will be able to troubleshoot most of the manufacturing process and equipment and where necessary make adjustments and minor repairs during setup and during operations.

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.

• Supervises manufacturing activities as defined by established operating procedures for multiple products on a daily and weekly basis by delegating resources as well as participating in the process.
• Responsible for the training and mentoring in all facets of the manufacturing process.
• Responsible for reviewing executed batch records and logbooks prior to submitting for final production review.
• Responsible for reallocation of personnel based on production needs.
• Responsible for creating weekly activity schedules to ensure production needs are met.
• Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules.
• Ensures only approved materials and equipment are utilized at all times.
• Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
• Ensures that only approved documentation and procedures are utilized at all times.
• Attends all training programs as required by Company SOPs, procedures and policies.
• 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.

• High School Diploma or GED equivalent required. Bachelor's in Pharmaceutical Science, Chemistry, [Micro] Biology, Engineering, or a related field is preferred.
• 1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group.
• Experience in manufacturing, the pharmaceutical industry, or with GMP/FDA regulations is a plus.
• Chemical handling, mathematical aptitude, and the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment is preferred.
• Experience writing, reviewing, and executing standard operating procedures.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

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.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 50 pounds.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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