Derek Bradley M.Sc. Email & Phone Number

Ireland

County Limerick, Ireland

Limerick, Ireland

Tullamore, Offaly, Republic Of Ireland

Responsible for coordinating all testing, project work, and associated activities to support Process Development and manufacture of biologics, day-to-day people management activities, and participating in cross-functional projects to support Quality Assurance, GMP-compliance and Regulatory Submissions.

County Offaly, Ireland

This employment was at the same location as my previous employment (below) following acquisition of NexVet by Zoetis. During this role, I was responsible for development and validation of analytical methods for protein/biopharmacetucial characterisation and routine testing. Associated activities included set up and support for stability studies, Process Development/Characterisation, and analytical equipment qualification and validation. In the last 6 - 8 months of this role, I assumed a more senior function, being responsible for scheduling of activities for the QC department and acting as a technical lead.

Tullamore

Early-phase of set up of a biopharmaceutical manufacturing site. Supporting process development, analytical method development and validation, equipment procurement and qualification (including qualification of legacy equipment), preparing requisite documentation (test methods, SOP's, forms, etc.), and participating in objectives to prepare the site for regulatory inspections.

Ida Business And Technology Park, Garrycastle, Athlone, Westmeath

Analysis of pharmaceuticals and biologics, including API and finished product.Clinical sample (blood, serum, plasma, tissues) processing and analysis from clinical trials.USP/NF, B.P., Ph.Eur and J.P. pharmacopoeial methods, and in-house method development and validation in a fully licensed and compliant cGMP/GLP setting. Core techniques include UV-Vis spectrophotometry, Mass Spectrometry, HPLC, ELISA, Bio-assay, Coagulation assays, Electrophoresis, Chromatography and other methods using a comprehensive suite of analytical instrumentation and associated software interfaces.I am also the company safety representative (see below), and deputy 'controlled substance' custodian.In addition to scientific research and routine testing duties at BioClin I am safety representative, a voluntary role which involves:Chairperson of the health and safety committee (6 members)Periodic review of company safety statement and safety policy.Carrying out monthly laboratory safety inspections identifying and possible safety concerns and communicating to management, then following up to ensure that they are appropriately addressed.Investigation and reporting of safety incidents; root-cause analysis; determining effective corrective and preventative actions (CAPA) to prevent re-occurrence.Risk assessments (particularly chemical hazard risk assessments in line with COSHH guidelines), documenting and maintaining records.Meeting with and liaising with HSA inspectors.Coordination of training of all employee’s including manual handling training, first aid training, and fire safety awareness and maintenance of recordsConsultations with employees and making representations on their behalf to management on HS&WW issues

Masters Degree In Science (Research Mode), Microbial Gene Regulation

My research was based on a multidisciplinary programme melding advanced concepts and practices in Microbiology; Cell and Molecular.

Bachelors Degree (Hons), Toxicology

Activities and Societies: Irish Toxicology SocietyThis multidisciplinary four year degree melded advanced concepts from the following core.

Leaving Certificate, 6 Honours At Higher Level

Chemistry; Physics, Biology, Mathematics, English, and H.E. Sc. & Soc. - all taken at higher level and honours obtained in all subjects..