About us:
RadioMedix Inc., a biotechnology company located in Humble, Texas, is looking for an experienced Pharmacy Technicianto work at its newly constructed GMP radiopharmaceutical manufacturing facility.
Manufacturing Associate Responsibilities:
- Aseptic manufacturing experience preferred, does not require radioactive compounding experience. The individual will be trained on the job
- Prepares radioactive compounded preparations in accordance with standards of practice.
- Perform the duties associated with compounding, dispensing, and distribution of radioactive products GaPSMA, Re186-nanoliposome, Ac225 PSMA,including data entry with paper-based production records
Ensure compliance with USP , , proposed regulations.
- Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations
- Perform aseptic techniques within a cleanroom environment for the preparation/processing of materials (ISO 5/7/8 clean room environments)
- Maintain a clean and safe working environment
- Perform radiation safety duties according to company’s Corporate Radiation Compliance Program and site licensing requirements
- Clean classified and non-classified areas according to SOPs
- Perform environmental monitoring of classified areas according to SOPs
- Complete cGMP documents as required and assist site and Quality Assurance as required
- Routinely originate or revise standard operating procedures (SOPs) and batch production records (BPRs). Performs manufacturing operations according to SOPs and BPRs
- Perform process validation activities
- Responsible for manufacturing radiotheranostic APIs and drug products
- Utilize quality management system software (PETRA) to complete manufacturing and inventory management documentation
- Assist RSO in Radiation Safety including wipes and surveys
Required Skills/Abilities:
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Ability to work independently towards self-directed goals
- Proficient with Microsoft Office Suite or related software
- Strong proficiency with Microsoft Excel preferred
Qualifications:
- 2-3 years of aseptic manufacturing or compounding pharmacy technician experience preferred
- Sterile compounding experience preferred.
- High School Diploma or equivalent is required
- Efficient in the use of MS Office Suite required
Physical Requirements:
- Standard office environment, coupled with approximately 70% time in clean room, radiopharmaceutical manufacturing, and laboratory environments
- Willingness to work in commercial manufacturing producing radioactive materials and safety programs designed to minimize potential and/or actual exposure levels
- Must be willing to wear a variety of personal protective equipment
- May be required to sit or stand for long periods of time while performing duties
- Must be able to work outside of regular work hours, including weekends and overtime as needed
Residency Requirement:
- Employees must permanently reside and work in the State of Texas
