Denis Mccarthy Email & Phone Number

Supervising the upstream and media manufacturing process.

Senior Upstream production specialist in a new start up biopharmaceutical site.

Carlow

Supervising the vial and syringe formulations shifts

Carlow

Cork

• Performed extensive work across both Upstream & Downstream processes. • SME for Bioreactors, Harvest and Media/Buffer processes. Trained in Cell Culture (Media Make-Up, Inoculation, Bioreactor, Centrifuge, Harvest) and Purification (Buffers, Chromatography, Viral Filtration, Bulk Fill) areas. • SME in site inventory control system (MAPS AS400).• Involved in coordination and performance of dispensing during site start up.• Performed first line maintenance & calibrated process equipment (pH, DO and pCO2 probes, as well as pH/conductivity meters, pumps, filtration Systems). • Performed extensive CIP & SIP of vessels and equipment.• Executed processing steps on manufacturing control systems (Emerson Delta V).• Authored and drove to conclusion Quality Investigations through QTS. • Authored and drove to conclusion Safety Investigations through SIMS and created risk assessments for various pieces of equipment and processes. • Wrote & reviewed manufacturing documentation (SOPs, batch records & logbooks).• Created production training curricula as part of site Learning Council.• Involved in commissioning of media and buffer vessels during site start-up.Key Achievement: Authored all SOPs and batch records used in media process, facilitated validation of all materials made in media area and also became an SME in bioreactors and harvest.

Sligo

• Performed bulk immuno-bioassays on the components of the viral diagnostic kits produced on the site.• Performed extensive maintenance on axsym and architect immuno-assayers.• Ensured quality of diagnostic kits matched required standards. • Carried out the large variety of assays involved at all times to GMP standards strictly adhering to batch records involved. • Operated stock system (BPCS AS400) and generated stock reports for when kits were passed fit for quality. • Performed aseptic techniques during mixing of components of some diagnostic kits prior to running assays.Key Achievement: One of an elite number who were fully trained on testing of all of the large variety of diagnostic kits manufactured onsite.

Limerick

• Received data of interest from scientific publications for our client, a major pharmaceutical corporation.• Entered data involved into a database based on keywords and on whether comments were negative or positive. Key Achievement: Rewarded for achieving highest level of productivity output amongst the team dealing with our client

Cork

• Cloned genes of interest in the field of apoptosis into a number of different vectors, using various techniques, such as TOPO and restriction site cloning.• Designed PCR primers used to amplify these genes using computer software.• Amplified up genes of interest from cDNA pool, using PCR from gene arrays developed onsite.• Created this cDNA pool from different animal RNA sources by reverse compliment PCR.• Obtained positive clones using RFLP.• Prepped positive clones for sequence analysis. Genes which were found to have good sequences were then transfected into cells for analysis.• Performed gel electrophoresis on a daily basis to separate DNA sequences according to size.Key Achievement: Solely implemented the creation of the cDNA pool used onsite using reverse compliment PCR and a variety of different animal RNA sources

Msc, Biotechnology

Bsc, Biochemistry