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. They ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate, and that 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 Team Member will be able to participate in all aspects of the Compounding Process. The Compounding Process includes: dispensing of raw material, sterile dispensing of raw material (Hilliard Facility), compounding, sterile compounding (Hilliard Facility), sterile filtration, controlling and utilizing chemical raw materials in accordance with batch directions; performing in-process QC sampling and on-site in-process testing of pH, oxygen content, clarity, etc., cleaning, assembling, and sterilizing small and large pieces of equipment, and the tear-down and line clearances of the manufacturing equipment. The Compounding Process will be performed in accordance with established production records and company SOPs in a concerted effort to manufacture sterile liquid pharmaceuticals. The Team Member will be proficient in all activities associated with the compounding process and be able to work with minimal supervision.

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.

· Proficient in all activities associated with the compounding process and be able to work with minimal supervision, will receive direction, training, and mentorship from the Senior Compounding Technicians.

· The Team Member will, with assistance from Senior Team Member/s, be able to troubleshoot minor equipment adjustments or machine diagnostics and repairs during setup and during, operation. and as needed.

· Utilizes scales, balances, and load cells to weigh materials and performs batch additions of materials. Utilizes blending, mixing and other homogenization technologies.

· Performs aseptic filtration setup and filter integrity testing and mass/concentration calculations to determine batch dosing in accordance with material potency.

· Stocks, gathers, and stages manufacturing supplies and equipment as needed. Gathers, stages, and returns. Assist all team members with equipment assembly and cleaning as required to support manufacturing activities.

· Physically performs compounding activities as defined by established operating procedures and as directed by Supervisor. Physically performs compounding related tests (daily performance verifications, pH measurements, dissolved oxygen content, filter testing, etc.)

· Ensure that only approved documentation and procedures are utilized.

· Oversee production supply, materials as needed.

· Cleans and stores equipment gathering and staging activities required to support manufacturing. Assisting with equipment and cleans areas as needed operating supply inventory control.

· Attends all training programs as required by Company SOPs, procedures, and policies. Assists in Training new employees on compounding and dispensing raw materials as well as equipment cleaning procedures.

· Is proficient in dispensing raw materials using balances/scales both inside and out of the Formulation Isolator, as well as direct charge into the vessel in accordance with SOPs.

· Reviews logbooks and batch documentation for accuracy during execution on the floor.

· Acts as the Lead in the Lead’s absence.

· 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. Associates or bachelor’s degree in chemistry or other science field is a plus.

· At least 1 year as a Compounding Technician I, having performed at a satisfactory level or 3 years similar work experience in a related field preferred.

· Experience with manufacturing technology such as HMI-PLC/SCADA controlled Isolation Barrier, Autoclave Sterilization, CIP Sanitization and SIP Sterilization preferred.

· Ability to work in an environment where chemicals are handled and dispensed daily.

· Excellent chemical handling and mathematical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.

· Ability to meet and maintain Class 100 Certification for sterile compounding/transfer (Hilliard facility) as well as maintain cleanroom gowning and respirator fit testing requirements.

· Able to take feedback constructively and function in a team-oriented work environment.

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

· Ability to work overtime as needed.

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.

Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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· Our recruiting process includes multiple in person and/or video interviews and assessments.

· If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.

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