Posted in Other about 3 hours ago.
Location: Boston, Massachusetts
The Radiochemistry Technician provides a variety of services to support the safe and efficient production and use of PET radiopharmaceuticals for research and clinical diagnostic use at BWH and other affiliated molecular imaging clinics. The incumbent will be involved in all aspects of daily operation of the BICOR radiopharmaceutical production facility operating under cGMP regulations, including the aseptic production area & fill lines, an analytical laboratory, along with associated cleanroom and stockroom operations.
The Radiochemistry Technician is an integral part of a multidisciplinary team who will assist in the development and routine operation of radiopharmaceutical manufacturing processes and is expected to master these new processes prior to training peers. The individual is also expected to assist in the optimization and process improvements to existing validated PET manufacturing processes, working closely with peers to properly document and implement the proposed changes in a cGMP compliant manner. The Radiochemistry Technician will develop and maintain an in-depth understanding of the technical and mechanical operation of complex automated radiochemistry equipment, as they will be responsible for troubleshooting the equipment during its routine use.
The major responsibility of this position is to produce the highest quality radiopharmaceuticals for human studies on a regular basis with full regulatory compliance. This involves but is not limited to:
1. Automated and semi-automated synthesis:
a. Set up, test, and operate automated synthesis modules.
b. Verify & record in-process and finished-product data.
c. Sample products for analysis of chemical and biological impurities.
d. Clean, calibrate, maintain, test, troubleshoot and maintain modules.
e. Prepare components and reagents for synthesis.
f. Support in the development and validation of new radiopharmaceutical manufacturing processes.
g. Recommend and collaboratively develop process improvements on existing, validated manufacturing systems and procedures.
2. Product Filling in an Aseptic Environment
a. Clean, calibrate, and set up kits for sterile product filling.
b. Perform filling operations.
c. Record data and apply labeling as needed.
d. Clean and maintain filling enclosures and associated equipment.
e. Dispose of radioactive and hazardous waste per SOP.
f. Transfer shielded materials to the distribution area.
3. Quality Control
a. Clean, calibrate, set up, and standardize analytical instruments.
b. Perform quality control tests under the direction of the QC authority and record results.
i. HPLC, GC, R-TLC, chromogenic determination of endotoxin content, sterility inoculations, gamma spectroscopy, osmolality
c. Clean, calibrate, maintain, test, troubleshoot and maintain instruments.
d. Prepare components and reagents for use in analytical methods.
e. Assist in the investigation of quality-related events occurring in during the synthesis, filling, and quality control procedures of radiopharmaceuticals.
4. Records
a. Review the appropriate SOP and complete the batch record for each production.
b. Maintain accurate batch records and supporting data both electronically and in the appropriate log books
c. Maintain accurate calibration and maintenance records both electronically and in the appropriate log books
d. According to the appropriate SOP, submit in writing the results of quality investigations and corrective action for all batches for human use that do not pass quality control criteria (OOS reporting)
5. Supplies
a. Maintain adequate levels of chemicals and disposables for clinical supply productions
b. Perform receiving and control procedures for chemistry reagents, manufacturing components, and testing materials used in the cleanroom in accordance with cGMP.
c. Conduct proper inventory control and materials management practices (e.g. Fi/Fo, quality review, growth promotion of media, inventory stocking)
d. Document the proper disposal of materials (radioactive materials, components rejected by QA, chemical waste)
e. Package radioactive materials according to SOP and DOT regulations for transport to molecular imaging clinics.
6. Good Manufacturing and G
The Radiochemistry Technician provides a variety of services to support the safe and efficient production and use of PET radiopharmaceuticals for research and clinical diagnostic use at BWH and other affiliated molecular imaging clinics. The incumbent will be involved in all aspects of daily operation of the BICOR radiopharmaceutical production facility operating under cGMP regulations, including the aseptic production area & fill lines, an analytical laboratory, along with associated cleanroom and stockroom operations.
The Radiochemistry Technician is an integral part of a multidisciplinary team who will assist in the development and routine operation of radiopharmaceutical manufacturing processes and is expected to master these new processes prior to training peers. The individual is also expected to assist in the optimization and process improvements to existing validated PET manufacturing processes, working closely with peers to properly document and implement the proposed changes in a cGMP compliant manner. The Radiochemistry Technician will develop and maintain an in-depth understanding of the technical and mechanical operation of complex automated radiochemistry equipment, as they will be responsible for troubleshooting the equipment during its routine use.
The major responsibility of this position is to produce the highest quality radiopharmaceuticals for human studies on a regular basis with full regulatory compliance. This involves but is not limited to:
1. Automated and semi-automated synthesis:
a. Set up, test, and operate automated synthesis modules.
b. Verify & record in-process and finished-product data.
c. Sample products for analysis of chemical and biological impurities.
d. Clean, calibrate, maintain, test, troubleshoot and maintain modules.
e. Prepare components and reagents for synthesis.
f. Support in the development and validation of new radiopharmaceutical manufacturing processes.
g. Recommend and collaboratively develop process improvements on existing, validated manufacturing systems and procedures.
2. Product Filling in an Aseptic Environment
a. Clean, calibrate, and set up kits for sterile product filling.
b. Perform filling operations.
c. Record data and apply labeling as needed.
d. Clean and maintain filling enclosures and associated equipment.
e. Dispose of radioactive and hazardous waste per SOP.
f. Transfer shielded materials to the distribution area.
3. Quality Control
a. Clean, calibrate, set up, and standardize analytical instruments.
b. Perform quality control tests under the direction of the QC authority and record results.
i. HPLC, GC, R-TLC, chromogenic determination of endotoxin content, sterility inoculations, gamma spectroscopy, osmolality
c. Clean, calibrate, maintain, test, troubleshoot and maintain instruments.
d. Prepare components and reagents for use in analytical methods.
e. Assist in the investigation of quality-related events occurring in during the synthesis, filling, and quality control procedures of radiopharmaceuticals.
4. Records
a. Review the appropriate SOP and complete the batch record for each production.
b. Maintain accurate batch records and supporting data both electronically and in the appropriate log books
c. Maintain accurate calibration and maintenance records both electronically and in the appropriate log books
d. According to the appropriate SOP, submit in writing the results of quality investigations and corrective action for all batches for human use that do not pass quality control criteria (OOS reporting)
5. Supplies
a. Maintain adequate levels of chemicals and disposables for clinical supply productions
b. Perform receiving and control procedures for chemistry reagents, manufacturing components, and testing materials used in the cleanroom in accordance with cGMP.
c. Conduct proper inventory control and materials management practices (e.g. Fi/Fo, quality review, growth promotion of media, inventory stocking)
d. Document the proper disposal of materials (radioactive materials, components rejected by QA, chemical waste)
e. Package radioactive materials according to SOP and DOT regulations for transport to molecular imaging clinics.
6. Good Manufacturing and Good Laboratory Practices
a. Follow all hygiene and aseptic gowning protocols
b. Maintain clean orderly work spaces
c. Control all in process and waste materials
d. Maintain records for all process equipment, environmental control equipment, and quality control instrumentation
7. Radiation Safety Practices
a. Operates the radiation monitoring system in accordance with SOP's
b. Performs all aspects of radiation exposure and release practices
c. Participates in the investigation and resolution of all anomalous occurrences
ood Laboratory Practices
a. Follow all hygiene and aseptic gowning protocols
b. Maintain clean orderly work spaces
c. Control all in process and waste materials
d. Maintain records for all process equipment, environmental control equipment, and quality control instrumentation
7. Radiation Safety Practices
a. Operates the radiation monitoring system in accordance with SOP's
b. Performs all aspects of radiation exposure and release practices
c. Participates in the investigation and resolution of all anomalous occurrences
Qualifications
