David Keen Email & Phone Number

St. Paul, Mn, Us

St. Paul, Mn, Us

Pharmig is a not- for-profit organisation and is the influential forum for microbiology in the pharmaceutical, healthcare and allied industries (this also includes but is not exclusive to - NHS, Cosmetics & Toiletries and Medical Devices). It provides a focus for continuing professional development and a unique network for the exchange of microbiological information.Pharmig researches with its members to put together comprehensive & topical meetings; training courses and conferences. It has also produced a variety of publications which include: Guide to Disinfectants and their use in the Pharmaceutical Industry; Guide to Microbiology Laboratories in the Pharmaceutical Industry; Microbiological Control for Non-Sterile Pharmaceuticals and Best practices for the Bacterial Endotoxin Test: A Guide to the LAL Assay. Some of our publications have had forwards written by the MHRA. Visit the Pharmig website for more information - www.pharmig.org.uk

Pharmig is a not for profit organisation providing help and advise to industrial microbiologists

London, England, Gb

Bethesda, Maryland, Us

Brentford, Middlesex, Gb

Proactive role designed to prevent microbial issues when working on bulk sterile products.Close working relationship with production teams.

Brentford, Middlesex, Gb

Leading a team of nine in support of sterile API manufacturing of antibiotics.Working through complex microbiological investgations in an MHRA/FDA compliant facilityRelease testing of bulk sterile products.

Slough, Berkshire, Gb

Working with manufacturing to prevent microbial contamination occurring. Providing pragmatic solutions to microbiolgical issues for our manufacturing departments.Working with Liquid oral products, CIP systems, creams, dry formulations and terminally sterilised injections.External and internal auditing of microbiologically sensitive areas

Running the sites technical department and working with our clients to ensure project deadlines are met

Microbiology, Specials Clinical ManufacturingProject manager for all client and in-house Aseptic and Terminal Sterilisation processesCompany/Client expert for Microbiology and Aseptic processing.Validation expert with Biological Indicators, including "sub-lethal" electron beam sterilization, gamma, steam and dry heat.Interdepartmental coordinator for client projectsAdvise on Isolator design, construction and validation for aseptic and potent/cytotoxic projectsCoordinating the implementation of a Risk Management Policy, incorporating process risk assessments FMEA, HACCP, RMC).Act as advisor and trainer to new Microbiology Manager until they found their feet.

Design, set up and validate a working microbiology lab from scratch to support pharmaceutical manufacturing.Purchase and validate all items of equipment required to support environmental monitoring, incubation and phenotypic identification of microbes, intermediate and finished product testing.Design and write all validation documentation, SOP's and test methodologies for use in the lab and in the clean roomsRecruit, train and manage members of the microbiology team, to work within the labs and support production activities in the clean rooms. Implement and train clean room changing procedures, microbiology training courses and aseptic handling courses.Front MHRA and client audits.Validation of Terminal Sterilisation processes of dose forms using Biological IndicatorsDesign, validate and purchase isolators and VHP gassing units for the production of aseptic productsDesign, train and implement Media filling trials to qualify production staff and client product processes, using isolatorsControl and testing of Biological Indicators, including in-house D-value studies for use in VHPsystemsDesign and validate microbiology product testing (including raw materials, components, intermediate and finished product testing)Overcome testing and validation issues when dealing with small volume IMP products.Aid clients in the optimization of their processes to improve efficiency, product quality and microbiological safety.Trained in performing risk assessments, such as FMEA risk management procedures of client product processes.Support the IMP manufacturing team in the production of bulk specials, non sterile, terminally sterilised and aseptic dose forms.Familiar with drug dose forms, such as liquids, vaccines, powders and topicals. Also experience in handling and working with unique dose forms such as needle free injection systems, sterile aerosol injections, super cooled drug carrier systems and patented inhalation devices

Brentford, Middlesex, Gb

Environmental monitoring of clean rooms and area aseptic suites. Investigations of microbial deviations. Challenging and improving current production methods of operationBasic microbial identification of isolates, including mycology, bacteriology, waters and product bulks/packs.Providing technical advice on aseptic operations and management. Including modes of operation, sterility assurance, risk assessments and production area audits.Simulation trial for machine set-up life, operator (re)qualification and asepsis assuranceSterility testing using a positive pressure, soft wall isolator.Isolator validation and cycle optimizationEndotoxin testing using Turbidimetric and Chromogenic methods

Environmental Monitoring of clean and sterile areas.Contaminant checking of samples.Standard Operating Procedures, Good Laboratory Practice and Good Manufacturing Practice.