Extensive expertise in Start Up of Aseptic Sterile Production Facilities recent projects & responsibilities:
Pharmaceuticals steriles project delivered from build, through validation, achieving regulatory licence to manufacture.
Deliver customer projects in sterile / aseptic drug development and manufacture for Phase 1 and 2 clinical trials
Delivering development, Phase 1 and Phase 2 Clinical manufacture including freeze drying within timelines and budget for customers projects Cross functional working with formulation, analytical, Quality Assurance and business development
Manage external contracts (for example microbiology and engineering
Operate Steriles Facility and Department within budget and targets
Input into customer regulatory submissions (IMPD)
Build, equipment procurement, validation to achieve the MHRA license on time and budget to manufacture IMP and specials
Senior R&D Executive Medical Device Ref OLPJK
Worked as R&D Manager with major global Medical Device Manufacturing company before becomng a Interim Executive. Recent Project include the following:
Medical Device Component Manufacturer: The contract brief was to identify alternative medical products that could utilise the core process capabilities of the company, and to facilitate the early development of these alternative products.
Early Stage Medical DeviceThe original contract brief was to critically review and re-direct the activities of the R&D group within the company and later held position of R&D Manager
Contracted to various Venture Capital companies to perform Technology Due Diligence on a number of start-up medical device companies
For more information on our Panel of Interim Managers & Technical Experts plesae email info@pharmaexecutives.com or telephone + 353 (0)1 2800430