PET Radiopharmaceutical Chemist II

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Company :
Massachusetts General Hospital

Location :
Charlestown, Massachusetts

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
PET Radiopharmaceutical Chemist II GENERAL SUMMARY/ OVERVIEW STATEMENT: Under direction of the Manager of the Martinos Center’s PET Production Chemistry, the Senior PET Radiopharmachemist provides a wide variety of services to support the safe and efficient production and use of PET radiopharmaceuticals for research use at the MGH Martinos Center. The Senior Radiochemist will be responsible for validation of new research radiotracers in preparation for use in human research protocols. Working with the facility manager, the senior radiochemist will supervise researcher interface with the production lab and will be involved PET radiopharmaceutical production under cGMPs. The senior radiochemist will play a major role in process optimization and radiochemical synthesis troubleshooting. Additional responsibilities of the Senior PET Radiopharmaceutical Manufacturing Chemist include: leading research, development and validation of novel PET radiopharmaceuticals for human use, drafting validation documentation, drafting of supporting Standard Operating Procedure (SOP) and other quality documents. The incumbent would also support the filing of regulatory documents for the use of novel PET radiopharmaceuticals. PRINCIPAL DUTIES AND RESPONSIBILITIES: – Working with the PET production team, leads efforts for the development and validation of new PET radiopharmaceuticals for human use at MGH in clinical and clinical research applications including: – Development and validation of synthesis of the novel PET radiopharmaceutical – Development and validation of supporting analytical methods for HPLC, GC, TLC, etc. – Drafting of validation documentation, associated Standard Operating Procedures (SOPs) and other quality documents – Supporting the filing of regulatory documents (INDs, ANDAs, etc) for the use of the novel PET radiopharmaceutical – Troubleshooting radiochemical reactions and automation – Investigating and testing hypothesis related to radiochemical synthesis failures – Implementation of chemical test methods – Optimization of chemical syntheses for radiochemical yields. – Facilitate preclinical research through optimization of infrastructure and process – Work with the facility Manager to enable preclinical researchers access to resources – Provide educational and training sessions to the researcher community – Assist with radiochemical method development for research projects using the facility resources. – Under cGMP’s, will be responsible for the production of PET radiopharmaceuticals including: – Setup and preparation of chemicals and reagents – Operation of automated radiochemistry synthesis units – Cleaning of automated radiochemistry synthesis units – Maintenance of automated radiochemistry synthesis units – Under cGMP’s, will be involved in the aseptic preparation of PET radiopharmaceuticals in a cGMP clean room environment. – Preparation of sterile filtration assemblies – Environmental monitoring of aseptic processes – Inoculation of sterility media – Under cGMP’s, will be involved in the in quality control and release of PET radiopharmaceuticals – Use of HPLC, TLC, GC, biological and radiometric tests required for release of PET radiopharmaceuticals – Actively involved in maintenance of cGMP clean room and production facility. – Involved in inventory management and stocking – Packaging of radiopharmaceuticals for transport SKILLS & COMPETENCIES REQUIRED: – Experience with synthesis and production and quality control of radiopharmaceuticals – Experience with chemical synthesis and organic chemistry analysis methods – Demonstrated track record for troubleshooting chemical reaction and processes – Experience with Microsoft Office, including Word, Excel, Outlook and PowerPoint – Understanding of universal precautions and infection control – Effective interpersonal, writing, and communication skills – Legible hand writing – High attention to detail – Must be able to lift 60 lbs – Must have the ability to handle multiple tasks simultaneously and to work in high-pressure situations EDUCATION: Minimum Required: Doctoral Degree EXPERIENCE: Required: – PhD in organic, medicinal (or related) chemistry with 3 years of radiochemistry experience using carbon-11 and/or fluorine-18 isotopes Preferred: – Experience in the handling of radioactive materials, aseptic preparation and clean room experience preferred. – Experience in developing analytical assays – Experience in drafting SOPs and quality documents – Experience in developing and validating PET radiopharmaceuticals for human use WORKING CONDITIONS: Day to day operations are performed at the Charlestown Navy Yard in a laboratory setting. Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged. MA-Charlestown-MGH 13th Street MGH 13th Street (MGHCharlestownBldg149) 149 13th Street Charlestown, 02129 MGH 13th Street 149 13th Street Charlestown PET Massachusetts General Hospital(MGH) Full-time Day Job Regular MGH Radiology Research Feb 4, 2021