Jobs and Careers

Manufacturing Associate

United Statesfull_timeVerifiedPosted 13 Jan 2025

About the role

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 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 <797>, <823>, proposed <825> 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