Analytical method development for Gallium products and routine testing of F18 products

Manufacture and QC testing of various radiopharmaceuticals. Primarily Ga68 and Tc99m products. Reconstitution of freeze dried kits and dispensing of patient doses within grade A isolators. Deputised planning and running of Gallium production schedule in absence of senior member. Utilisation of automatic synthesis units for radiopharmaceutical production. QC testing of radiopharmaceuticals: HPLC, TLC, pH and Endotoxin. Working within a clean room from grade D to A. Working closely with QA on compliance and timely release of short shelf life products.

• Conducting Quality Control analysis on commercial F18 radiopharmaceutical batches, not limited to: HPLC analysis of carbohydrates via an electrochemical detector & also radio-detector GC analysis of residual solvents using FID Radio TLC Gamma spectroscopy Microbiological monitoring (settle/contact plate incubation and reading)• Working to tight schedules due to short shelf like of product (12hrs) Completing analysis within very short timeframe to allow release of product before 1st injection of the day Maintaining, repairing and troubleshooting all equipment and processes to prevent delays in batch release Working efficiently with the production team to ensure product is shipped in good time Compiling all data and documents with accuracy and clarity for immediate QP review Explaining and discussing any issues/OOS/OOT’s with other members of staff or QP’s clearly and confidently Completing GMP tasks promptly to ensure further batches are not impacted e.g. OOS/OOT, Deviations, CAPA’s & Change controls.

Job role includes:Manufacturing within clean room environments (Grade A through to D) Sterile dispensing of intravenous injections within an isolator for sterility and radiation protection. Aseptic preparations of starting materials/primary packaging.Following gowning and cleaning procedures for clean rooms.Monitoring of the graded environments for compliance.Operation of a cyclotron particle accelerator for the generation of radio-nucleotides. Set up and management of the chemistry modules for the synthesis of radiopharmaceuticals.Working to a very tight schedule due to the short shelf life of radiopharmaceuticals.Completing all documentation and following SOP’s to cGMP requirements.Performing under pressure as a team to ensure batch manufacture, shipment & release are on time.Carrying out deviation investigations and implementing CAPA’s/Change controls in a timely fashion.Keeping all aspects of health and safety, including radiation safety, at a very high level.Conducting troubleshooting/repairs and preventative maintenance on all areas of the production line: e.g. Cyclotron troubleshooting, hot cell cleaning, vial exit maintenance, chemistry module repairs.

• Completing routine analysis of raw materials following methods in the EP, USP and corporate specifications:  Wet Chemical ID tests & titrations, FTIR, Raman, XRF, Karl Fisher, GC, density, refractive index, polarimetry, sieve tests, Loss on Drying/Ignition, Sulphated ash/Residue on ignition and other techniques outlined in EP/USP and GSK Specs.• Performing Documentation and security/seal checks on bulk deliveries of raw materials in tankers.• Sampling the tanker deliveries and performing pre-release analysis in a timely fashion to authorise immediate offloading of the material into the silos. • Assisting the Finished Products lab during times of increased work load:  Ion Chromatography, pH, viscosity, density, stability testing on samples stored at elevated temp & humidity. • Investigation of Out Of Spec (OOS) samples and raising Laboratory Investigation Reports (LIR’s) on all atypical results. Carry out Root Cause Analysis (RCA) and determine if a Deviation needs to be raised/escalated to higher management. • Utilisation of the Laboratory Investigation Management System (LIMS) for sample tracking and release.• Strictly following all cGMP and SOP’s during daily activities.• Raising all Health and Safety concerns and implementing Corrective and Preventative Actions (CAPA’s) once discussed. • Working effectively as a team to release all raw materials required for the production schedule

• Manufacturing extemporary pharmaceuticals to precise specifications Compounding oral suspensions and solutions from API’s & crushed tablets/capsules Compounding external medicines for topical use Bulk manufacturing of capsules using the Profiller 3700 Training to become a ‘double checker’ for the authorisation of compounding processes Managing stock within the stock database to assist in the upkeep of the laboratory

• Preparing various application forms submitted for the financial departments e.g. Housing Benefits, Council Tax, Financial Assessment Team and Home Ownership.• Processing confidential documents and verifying identities e.g. passports, bank statements, payslips, Birth/Death certificates etc.• Locating the customer within the database and assigning the correct task process to the account.• Keeping records of each process and evidence provided to avoid the loss of important documents.• Mailing important documents back to the customer ensuring that the data protection act is not violated. • Working with the rest of the team to ensure the workload is completed within the deadline.

- Responsible for the collation, analysis and dissemination of programme data​: - Responsibility for collating Maggie’s Centre's activity figures and centre utilisation data. - Contribute to the Quality Assurance, Programme Annual Audit.- Report writing - Responsibility for developing and producing reports, presentations, and other documents as required by the Programme Director, including papers for Executive and Board meetings/presentation.- Assist in the implementation of funding proposals through the provision of accurate data.- Review existing system and processes for programme activity data recording and establish a new system/process to meet both current and future requirements (implementation will be required during 2016).

As a tutor at Explore Learning I was required to supervise a mixed ‘zone’ of up to six children, aged 4-14, as they carried out educational activities. I provided support when the children asked for assistance with a question or activity. A ‘session note’ for each child was generated as they worked to show their parents what topics they covered that day and to provide feedback on how they are doing. Good leadership skills, effective communication and patience were essential to build an engaged learning environment.