Sterile Manufacturing Operator Pharmaceuticals - SynergenX

TomorrowMed Pharma is a pioneering 503B manufacturing facility poised to revolutionize the pharmaceutical compounding industry. Situated in the heart of Research Triangle Park in Raleigh, NC, this brand-new cutting-edge cGMP facility adheres to strict regulatory standards set by the FDA to ensure the safety, efficacy, and quality of all our products. At TomorrowMed Pharma, we are committed to setting new standards in quality, innovation, and patient-centric care.

Driven by a passion for healthcare and a commitment to continuous improvement, we are constantly exploring new opportunities for growth and innovation in the compounding industry. With a collaborative and supportive work environment, we empower our employees to thrive and make meaningful contributions to our mission of enhancing patient care through customized medication solutions.

Join us in our pursuit of excellence and become a valued member of our team as we continue to lead the way in 503B pharmaceutical manufacturing.

The Sterile Manufacturing Operator (SMO) is responsible for executing all processes related to the manufacturing of sterile products at TomorrowMed Pharma's 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211 and USP <797>/<800> regulations, current Good Manufacturing Practices (cGMP), and the department's Standard Operating Procedures (SOPs).

Duties and Responsibilities:

• Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
• Manufactures sterile products accurately and in compliance with master batch records while adhering to department specific SOPs.
• Utilizes appropriate aseptic technique when performing tasks within the cleanroom.
• Operates all fill-finish and ancillary manufacturing equipment in order to deliver quality medication.
• Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance with approved procedures.
• Assists with sterilization of components used in the manufacturing process.
• Performs essential calculations and completes thorough documentation.
• Methodically prepares work area and supplies prior to manufacturing.
• Performs transfer of products from the cleanroom to the Inspection and Labeling team.
• Maintains on-going training and qualification in sterile operations.
• Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, autoclaving, bubble point testing, compounding, material preparation, inventory accounting, labeling, organization of components, and various LEAN manufacturing tasks (6S, GEMBA, Kaizen).
• Performs other duties and responsibilities within the department to ensure timely execution of the production schedule.
• Ensures all required hygienic practices and garbing are performed per company policy.
• Achieves "Gown and Glove-Fingertip Qualified" status within two attempts, allowing entry into the cleanroom.
• Observes and aids in coaching new hires on sterile operations.
• Is dependable with attendance and is on time for each shift start.
• Provides overtime support, as needed, to maintain appropriate inventory levels.
• Assist with special projects, as needed.

Qualifications/Requirements:

• A high school diploma or equivalent, required.
• Aseptic Operator training and experience in sterile manufacturing required.
• Prior cGMP experience manufacturing sterile products preferred.
• Work in a confined, controlled environment for extended periods of time (4 plus hours).
• Must be able to work with hazardous substances (drugs) and work with strong odors.
• Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery.
• Ability to carry out detailed written or oral instructions.
• Must be able to fully gown in aseptic garb for extended periods of time.
• Must pass gowning sampling within two attempts for entry into the cleanroom.
• Must be able to perform rudimentary mathematical calculations as related to compounding or manufacturing processes.
• Must be able to stand and walk for extended periods of time for consecutive days.
• Must be able to lift up to 50 lbs.
• Pass a Criminal background check.

Hours and Location:

1st Shift M-F 7am-4pm

2nd Shift M-F 12pm-9pm

Facility Located in Raleigh, NC 27560 in the heart of Research Triangle Park

Comprehensive benefit package is included!