Mark Cuban Cost Plus Drug Company is looking to hire candidates for a Formulation Technician role here in our Dallas, Deep Ellum location. The Formulation Technician position is responsible for supporting weighing and dispensing chemicals to support product formulation. The Formulation Technician will also be responsible for material movement within the clean areas and from the formulation suite to the sterile fill suite. This employee should be familiar with quality-regulated manufacturing environments and current Good Manufacturing Practices. In addition, the Formulation Technician will work closely with the Pharmacist In Charge to ensure compounded sterile preparations are accurately identified, measured, diluted, and mixed.
Duties and Responsibilities:
- Weigh, dispense, and mix chemicals following product formula outlined in the batch record
- Stage, load, operate, and monitor all equipment for product formulations
- Safely transport chemicals (raw materials) within the clean areas
- Follow established GMP gowning and de-gowning requirements for designated work area
- Maintain room materials, supplies and process documentation per applicable SOPs
- Perform in-process analytical checks on the batches and make adjustments to meet required drug specifications
- Ensure equipment (analytical balance, pH meters, autoclave) is in a calibrated state by performing daily checks and troubleshoots as needed
- Perform Daily/ Bi-Weekly/Monthly cleaning of designated clean areas and fills out appropriate forms/documents in accordance with SOPs
- Comply with 503B guidelines; cGMPs, and company standards
- Alert production management and/or shift lead of any potential deviations to established processes or procedures
- Must ensure tasks are completed in compliance with all regulatory requirements
- Maintain and stay current on all necessary training including GMP and work-related classroom training required to support packaging operations
- Conduct line clearances and complete necessary documents for accountability and traceability of product following Good Documentation Practices (GDPs)
- Must be available to work overtime based on company’s needs
Education and/or Training:
- High School diploma or general education degree (GED) required.
- 30 college hours or college coursework in chemistry, biochemistry, or related field of study
- Knowledge and demonstrated understanding of Good Manufacturing Practices (GMPs) and how it applies to specific responsibilities and manufacturing operations.
- Ability to work independently with little to no supervision.
- Demonstrate Good Documentation Practices (GDP).
- Demonstrated ability to read, write, and speak English effectively.
- Experience working in a high paced clean room environment preferred.
- Familiarity with pharmaceutical drug products, sterile compounded products, and/or biologic drug products.
- Familiar with online training applications.
- Proficient with MS Office application skills.
- Self-motivated and detail oriented.
- Timely and punctual.
- Excellent verbal and written communication.
- Capable of lifting 50 lbs and stand for extended periods of time for consecutive days.
- Able to work safely around hazardous substances (drugs).
- At least 1 year working in a quality regulated, pharmaceutical environment or facility.
- Experience / participated in FDA or similar regulatory inspections.