Brian Stanley Email & Phone Number

Dublin, County Dublin, Ireland

• Time sensitive critical testing.• Analysis of stability, in-process, drug substance and drug product samples.• Conducting assays such as Capillary Electrophoresis, Gel Electrophoresis, Karl Fischer titration, UV Spectroscopy, pH.• Preparation of solutions, standards and buffers.• Conducting all testing in line with current Good Manufacturing Practices, site/company policies and SOP’s.• Review of GMP documentation.• Use of software such as LIMS, 32 Karat, Empower. • Calibration and standardization of relevant instrumentation.• Write-up of conducted assays and ensuring compliance GDP and company policies.• Completing daily lab, 5s and safety walkthroughs.• Maintaining the lab and workplace to a 5S gold standard.• Training and mentoring of new colleagues.

Ireland

• Processing PV events and product quality complaints.• Reconciliation of case reports with internal and external sources.• Liasing with clients for service requests and queries.• PV quality checks and source date verification activities.• Information resource to PV Team for training and other multidisciplinary teams.• Creation, preparation and Implementation of incident reports and CAPAs.• Interim Management and coordination of the PV team for several months through a transitional period.• Preparation and presenting of inter company meetings driving statistical analysis, reconciliation and corporate agreements.

Ireland

Processing PV events and product quality complaints.Reconciliation of case reports with internal and external sources.Liasing with clients for service requests and queries.PV quality checks and source date verification activities.Information resource to PV Team for training and other multidisciplinary teams.Creation and preparation of incident reports and CAPAs.

Carlow, County Carlow, Ireland

Creation and maintenance of BOM's through SAP.EHS auditing of work environment.Preparing GMP documentation for obsolete materials on site.Responsible for data accuracy and change control for SAP Master Data.Use of Midas, SAP, APO, MES, Appian and Trackwise to correctly maintain master data.Completing projects such as creation of SOPs and the revision of documents in circulation.

County Dublin, Ireland

Internal auditing in ISO 17025 and EHS.Maintenance of document management system Proquis to ensure that users have access to current versions of documents used in the company and cataloguing of complaints.Keeping track of and assigning actions to staff for closing out complaints and the steps to follow in the case of an FSN or product recall (In addition to notifying the governing body).Completing projects such as creation of SOPs, supplier bona fides, preparing Fannin quality FAQ, updating the internal auditing log and our certificate & risk database.Answering customer queries regarding Brexit.

County Cork, Ireland

The dissertation for this project was 'Growth optimisation of Polaromonas; an emerging species of potential importance in dairy wastewater treatment'. The aim of the project was to charcaterise and determine if the bacteria Polaromonas has properties that can be used to benefit the dairy wasterwater treatment industry.In the undertaking of this Lab project, a considerable amount of independent research was carried out.Techniques used include; Analyzing the biomass of sludge accomplished by determining the organic and inorganic material in the sludge. Measuring the Chemical Oxygen Demand on a spectrophotometer.Measuring Orthophosphate on a spectrophotometer.Measuring Ammonia by Nessler method on a spectrophotometer.Using Gel Electrophoresis to determine if separation has occurred for 16S PCR.Preparing samples for 16S PCR.Using a Nanodrop spectrophotometer to determine DNA and RNA concentration.Growth promotion techniques for microorganisms.

Athy, Co. Kildare, Ireland

Maintenance of document management system EtQ Reliance to ensure that users have access to current versions of documents used in the plant.Updated document set as part of system migration project.Sustaining sensory program on site and making usage decisions through SAP based on the findings.Managed the distribution of supplier MSDS to our global ingredient sharepoint.Streamline efficiency and improved productivity through 6sigma/ lean.Updating the 6S audit assessments and weekly plans each week.Collection, preparation and distribution of concentrate samples for third party testing and customs checks.

Kilkenny, Co.Kilkenny

Tasked to further research into brand market areas.Advancing experiments on research projects.Investigation into new products by sensory and triangle tests.Prepared products for shelf life tests.Conducting PSD tests through a masteuriser to investigate fat content .Use of MS office to transfer PSD results from batches under investigation to easily readable information on graphs.

County Carlow, Ireland

My final year dissertation was ‘Isolation and characterisation of PAH degrading Microorganisms from Evergreen forestry soil’. The aim of the project was to analyse different soil samples and catalog any microorganisms that were capable of breaking down polycyclic aromatic hydrocarbons, for future bioremediation use.

Master'S Degree, Food Microbiology

Activities and Societies: UCC Bulldogs Rugby, SquashModules covered in detail throughout the degree; Analytical Food Microbiology, Food.

Bachelor'S Degree, Bioscience With Biopharmaceuticals

Activities and Societies: GAA, PilatesModules covered in detail throughout the degree; 1st Year - Biology, Chemistry, Physics, Forensics/.