Experience and Expertise – John Mather brings his own particular brand of it to LabLogic
29 January 2014
John Mather is no stranger to the world of PET pharmaceutical production. Indeed, in his new role with LabLogic he will be drawing on his extensive experience in this field to offer expert advice to customers operating within this expanding sector of the healthcare market.
The complex procedure of PET pharmaceutical production is one that John knows well. From his early work as a Quality Control Manager at pharmaceutical manufacturer Syntex, and later at Mallinckrodt, where he first became involved closely with PET techniques - setting up and optimising a facility producing F-18 FDG and N-13 ammonia - he has been heavily involved in the world of analytical chemistry and its associated disciplines.
Further involvement with PET continued when John joined Bioscan. Tasked with providing support for PET manufacturing, he produced designs and specifications for the set up and operation of PET facilities and worked closely with the teams operating the PET chemistry synthesis units and quality control equipment. This involved developing customer training courses and creating standard operating procedures. In addition to installing and supporting PET manufacturing equipment at a number of locations in the United States, John also assisted in the design and development of new radiopharmaceutical synthesisers.
John continued working in this area with the Diversified Pharmacy Group, overseeing the manufacture of PET radiopharmaceuticals at three facilities and installing, maintaining and operating chemistry synthesis units and quality control equipment. Whilst in this role he was responsible for writing, reviewing and implementing standard operating procedures to support a new drug application.
Stepping up to IBA Molecular as their Director of Production, John supported the manufacturing of PET radiopharmaceuticals at eleven facilities, taking responsibility for troubleshooting, maintenance of analytical instruments and chemical modules as well as training operators in their use.
Meeting regulatory demands is all part of the PET process and it is an area in which John has a wealth of first-hand experience. Continuing his work at IBA as Director of Quality Assurance, he managed the QA group through the satisfactory closure of an FDA warning letter and as a result took on the responsibility of first line responder during seven subsequent FDA inspections. In this key role he managed the responses to FDA observations and took the lead in organising the transition from USP 823 manufacturing to 21 CFR Part 212 compliance. In the course of managing the project John prepared and filed two ANDA applications, oversaw the company’s Quality Management System which included creating job descriptions, standard operating procedures, training and qualification.
In the course of his career John has gained a great deal of experience and expertise in the PET pharmaceutical production sector, working with multiple cross functional teams on a host of projects across the world. The benefit of that experience will now be available to LabLogic’s customers, helping them to negotiate a successful path to safe and efficient production.