Michael Phinesee

Background

About Michael Phinesee

With 20yrs experience in a solid dose Pharmaceutical environment, encompassing everything from on hands manufacturing in production, to pilot R&D manufacturing trials (with scale up and Bio-study submission work), I have now added to this experience by branching out into the Bio-Pharmaceutical industry, of which I have now attained a further 8yrs of experience. This now brings my total GMP experience to 28yrs within the two combined industries. My 20yrs at Alphapharm Pharmaceuticals has seen benefit from skills such as, manufacturing of solid dose pharmaceuticals in all processes including dispensing, wet granulation, sieving, crushing, blending, tablet compression / coating, & granule encapsulation. Writing relevant SOP's and maintaining documentation standards (including document review & updates), compliance & reconciliation roles, QA checks and testing, as well as management roles such as R&D Manufacturing Facilitator, Production Team Leader, and 1st point of call as the Nightshift Production Coordinator for ~18 staff members. These roles also required skills in Staff Performance management & reviews, H&S audits / Risk Assessments, as well as improvement initiatives for Production output increases. Now branching out into the Bio-Pharma industry I have now learnt new and exciting skills at a world class standard. Within these past 8yrs at Patheon / Thermofisher Scientific, I have become an asset in the Downstream department as a senior Bioprocess Scientist, achieving and maintaining all skills in protein purification, such as Chromatography capture steps (both bind / elute, & flow through steps) with experience using Unicorn software 7.1, Virus Inactivation, Virus Filtration, UFDF (ultrafiltration & diafiltration), as well as Final fill using a controlled filling skid. pH, Conductivity, Endotoxin, OD280 & SoloVPE (UV absorbance) testing are performed on a daily basis, with aseptic techniques maintained both in handling the product, as well as within the laminar flow booths for sampling. As a senior figure, it has been my responsibility to train and sign off new staff through their skill attainment, as well as controlling and coordinating the maintenance tasks DSP were responsible for. SOP & GMP standards were always maintained either in the office space whilst creating or reviewing documentation, or in the facility in the B and C grade GMP areas. I am currently seeking to expand into something new, whether it be at a different pharmaceutical or Bio-pharmaceutical facility, or into the oil and gas industry. Open to discuss any further opportunities.