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 ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing areas 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, compounding, sterile compounding, sterile filtration, 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.
* Able to provide training and mentorship to all junior Compounding Technicians as needed.
* Responsible for the proper use of batch documentation.
* Be able to troubleshoot most of the compounding process and equipment and where necessary make adjustments and minor repairs during setup and during operations.
* Physically perform compounding activities as defined by established operating procedures and as directed by Manager/Supervisor.
* Physically perform compounding related tests (daily performance verifications, pH measurements, pH adjustments, dissolved oxygen content, filter testing, etc.)
* Ensure equipment and supply inventories are maintained and available for use in accordance with production schedules.
* Ensure only approved materials and equipment is utilized at all times.
* Ensure 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.
* Ability to perform machine diagnostics and repairs as required.
* Provides mentorship and training to junior members of Compounding.
* Physically performs and oversees ingredient dispensing, mixing, in-process testing during compounding and provides documentation oversight for such activities.
* Attends all training programs as required by Company SOPs, procedures and policies.
* Perform any other tasks/duties as assigned by management.
* We all must embrace the QUALITY culture.
Qualifications and Requirements
* High School Diploma or GED equivalent preferred. Associates or Bachelor's Degree in Chemistry or other science field is a plus.
* At least 1 year as a Compounding Technician II, having performed at a satisfactory level or 3 years similar work experience in a related field preferred.
* 1 year experience in a training role 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.
* 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 Physical 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.
American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Roz Russo, Talent Acquisition Senior Manager at 631-205-2068 or email at
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.