About us:
RadioMedix Inc., a biotechnology company located in Humble, Texas, is looking for an experienced Manufacturing Associate to 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 jobPrepares 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 recordsEnsure compliance with USP , , proposed regulations.Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulationsPerform 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 environmentPerform radiation safety duties according to company’s Corporate Radiation Compliance Program and site licensing requirementsClean classified and non-classified areas according to SOPsPerform environmental monitoring of classified areas according to SOPsComplete cGMP documents as required and assist site and Quality Assurance as requiredRoutinely originate or revise standard operating procedures (SOPs) and batch production records (BPRs). Performs manufacturing operations according to SOPs and BPRsPerform process validation activitiesResponsible for manufacturing radiotheranostic APIs and drug productsUtilize quality management system software (PETRA) to complete manufacturing and inventory management documentationAssist 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
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