Pharmacist Sterile Compounding Manufacturing

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 Pharmacist is a quality liaison assigned to review, verify, and approve manufacturing operations such as processing sourced material, equipment component preparation, sterilization, aseptic filtration, aseptic filling, inspection, and packaging, and batch review. This role will assist with quality in-process and quality investigations as a form of quality operations. This role is also responsible for overseeing processes in the production of compounded sterile preparations, while strictly adhering to current Good Manufacturing Practices (cGMP), USP 797/800, and department Standard Operating Procedures (SOP). The Sterile Compounding Pharmacist coordinates with management, PIC, and support departments to reach safety, quality, and delivery goals. This position is responsible for managing the product inspection and labeling of finished product. This role will ensure all inspection, labeling, and kitting processes adhere to cGMP, company standards and SOPs.

Duties and Responsibilities:

• Reviews and updates manufacturing documentation associated with manufacturing areas.
• Coordinates and provides USP and/or cGMP job-related training for personnel in the manufacturing areas.
• Oversees formulation (mixing) process.
• Oversees compounding process.
• Reviews batch records.
• Assists with quality and compliance related initiatives.
• Provides quality oversight to operators in the Sterile Suite.
• Assists with quality-related investigations as needed.
• Performs deviation investigations related to assigned area of responsibility along with implementing corrective actions to prevent recurrence of such deviations.
• Interacts with all supporting departments to ensure production deviations, change control, and any non-conformances are dealt with promptly and with appropriate quality considerations.
• Ensures that all environmental monitoring limits are maintained in all areas.
• Assists with revising, creating, and ensuring compliance with SOPs regarding process changes, regulatory guidelines, or as needed.
• Effectively solves problems around sterile manufacturing.
• Substitutes in manufacturing as needed when operations require additional help.
• Responsible for production schedule.
• Maintains compliance with regulatory functions (USP and/or cGMP).
• Actively contributes to the resolution of manufacturing equipment and process issues.
• Performs deviation investigations related to assigned areas of responsibility along with implementing corrective actions to prevent the recurrence of such deviations.
• Creates, implements, and manages the product inspection and labeling processes; assuring visual inspectors comply with company SOPs and policies, as well as provide positive feedback regarding work performance and adherence to cGMP regulations and industry standards.
• Supports label printing activities and document review.
• Forecasts and sets goals and objectives, identifies and allocates resources as needed.
• Leads and assists the PIC with hiring and interviewing of new employees. Provides coaching and counseling to area personnel.
• Performs other duties as assigned.

Hours and Location:

Shift will be M-F 12pm-9pm

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

Required qualifications:

Required to have Pharmacist license in good standing for North Carolina, 3 years pharmacy experience, Sterile Compounding certification, cGMP, aseptic processing and USP 797/800 background

Comprehensive benefit package is included