J Roberts Associates & Pharmig Committee Member
Julie has 25 years in the Pharmaceutical industry working for multi-national companies such as AstraZeneca, GSK and Eli Lilly. In recent years she has worked in an international corporate role assessing sites for due diligence and inspection readiness across all dosage forms. As an experienced microbiologist, Julie has also designed, set up, managed and audited microbiology laboratories and provided remedial support where required. With a strong technical competency in API operations and parenteral manufacture, Julie has practical experience in water system design and qualification, clean room classification, EM programmes. Julie became eligible to work as a Qualified Person in Europe in 2001, is a power user of TrackWise and has lean Six Sigma experience as a Green Belt. Since becoming an independent Consultant Julie has worked extensively in Asia, Europe and the US conducting on-site gap analyses against EU and US regulations, coaching, training and educating staff to remediate gaps and prepare them for FDA inspections and EMA/MHRA audits. Julie conducts work under her own company name ‘J Roberts Associates’ and also as a consultant for the US-based consultancy group ‘Jeff Yuen & Associates Inc.’, and the Irish-based consultancy group ‘McGee Pharma International’ and is a current Pharmig committee member.
Head of Microbiology
UK Bio Products Laboratory & Pharmig Committee Member
Tim is the Head of Microbiology at the UK Bio Products Laboratory. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. In addition, Tim is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and is a tutor for the university’s pharmaceutical microbiology MSc course. Tim is a chartered biologist and holds a first class honours degree in Applied Biology; a Master degree in education; and a PhD in microbiology. Tim serves on several national and international committees relating to pharmaceutical microbiology and cleanroom control (including the ISO cleanroom standards), and he has acted as spokesperson for several microbiological societies. He is a committee member of the microbiology society Pharmig. Tim has written over one hundred-and-fifty book chapters, peer reviewed papers and technical articles relating to microbiology.
Senior Global Microbiology Consultant
Ecolab & Pharmig Chairman
David is a microbiologist working for Ecolab as a Senor Global Microbiology Consultant for their Lifesciences division. David got his first taste of Pharmig quite a depressing number of years ago. In 2007 he became a committee member of Pharmig. In November 2013 he had the honour of being elected as Pharmig Chair. David started life at GSK Barnard Castle. Here he performed environmental monitoring and clean room qualification before moving on to sterile finished product testing. David then moved to a small start-up company called SCM Pharma. Here he set up a new microbiology lab and developed a new microbiology team. He helped design and qualify the new clean rooms. He then moved from microbiology to project management and became the technical manager. David then moved to Reckitt Benckiser at their Hull site where he discovered the magic and pain of working in an FMCG environment. His role was to improve microbiological awareness on the site and a large amount of time was spent investigating significant microbial contamination events with suppliers and products. He was lucky enough to be sent across the world investigating microbiological issues on behalf of the company. If you get caught by him at the bar, he can bore you to death on the wonders of seaweed. In 2012 David moved back to GSK at the Ulverston site in the Lake District. This is a large scale primary API manufacturing site makes bulk sterile antibiotics. It uses isolator technology in a primary environment, which was a bit of a steep learning curve. David started a new role as a microbiological consultant for Ecolab in March 2018. In this role David utilizes his experience to help Ecolab’s clients with microbiological and manufacturing issues, across the globe. David is experienced in most drug dose forms from sterile needless injection systems, explosive aseptic ampoules to inhalation devices, oral doses of microbial sensitive products and sticky capsules. Plus a great deal of primary manufacturing to boot. He is now dipping his toe into the world of disinfectants and contamination control – a microbiologist’s best friend.
RedLotus Pharmtech and Pharmig Overseas Ambassador
Manish Bhatkar is an experienced pharma professional, diligent in his core functional area (pharmaceutical technical operations) and committed to the profession. Before founding RedLotus Pharmtech Private Limited (A Technical Services Company) in 2016, in his 25 years of service, he has discharged executive as well as leadership responsibilities in the areas of design & development, manufacturing, qualification & validation, operations management, quality assurance, quality management, audits & compliance, regulatory affairs, technology transfer, project management, and technical consulting. He has worked in R&D, API’s, formulations and technical consulting environments and has demonstrated equivalent capabilities in managing manufacturing, technical as well as quality operations with ease. He was instrumental in establishing and growing the validations & GMP compliance services business vertical for a German pharmaceutical engineering house Pharmaplan GmbH (Now, NNE Pharmaplan) in India. As head of the Dabur Oncology Plc. Operations, in his 5 years’ tenure in UK, he single handedly led the efforts in resolving complex technological, regulatory and GMP compliance issues (including USFDA warning letter) that resulted in making commercial manufacturing and product supplies possible from the site. As head of Lupin Limited’ Technical Services, he lead the mission to transform the quality mindset and culture at their Goa manufacturing facility for meeting the exceptional and extreme Japanese quality requirements/ expectations. International experience of working in different geographies and work cultures helped him further strengthen his technical as well as leadership skills and capabilities. His main area of expertise is aseptic processing & areas of interests are sterility assurance, manufacturing technology, process validation, failure investigations, trouble-shooting, continuous improvement and resolution of complex technical/ regulatory/ GMP issues. Additionally, he has lead team of experts in preparing the inspectional observations of various regulatory agencies, such as WHO, ISO, USFDA, UK-MHRA, ANVISA, ENVIMA, Russia, Romania, Hungary, Germany etc. Manish has worked with medium to large, well respected pharmaceutical products manufacturing and services organizations like Dr. Reddy’s Laboratories Ltd., Lupin Limited, Dabur Oncology Plc. UK, Pharmaplan (India) Ltd., and Zydus Cadila. He has been involved in many projects from concept design to successful delivery of commercial product to the continuous improvement phases and also led organization(s) efforts and teams in managing and resolving regulatory challenges like regulatory review/ inspectional observations, warning letters and consent decree. Manish has also joined the Pharmig Committee as an overseas ambassador