John Milne Phd Email & Phone Number

Dublin, Ireland

Ireland

Founder of JJM ConsultingHighly motivated, dependable and quality driven professional with 15+ years experience in the Biopharmaceutical Industry. Consultancy offered in all aspects of the manufacture of biological products including process development, optimization, technical transfer, scale-up and clinical production using current best practice technologies.Preparation of process documentation including standard operating procedures, validation protocols and miscellaneous technical documents and reports.Excellent project management skills with a proven record in the direct management of staff, client relationships and third party contractors.

Dublin, Ireland

The core challenge of my role is to implement policies and procedures to ensure GMP compliance for the development and manufacture of biotechnology derived active pharmaceutical ingredients (APIs). Activities include• Responsibility for all technical operations including staff.• Preparation of regular technical reviews and reports as necessary.• Promotion of BioUetikon and meeting with client companies for project proposal evaluation. • Supporting Marketing team in business development e.g. follow-up client contract discussions, pricing and negotiations, attendance at partnering meetings and scientific conferences.• Technical transfer of client processes into and out of the BioUetikon facility.• Review and approval of documentation including quality protocols and summary reports. • Preparation, review and approval of standard operating procedures.• Preparation of downstream processing batch records in the areas of chromatography and filtration.• Scale-up of recombinant protein purification processes from laboratory bench to commercial scale.• Preparation and review of facility, equipment and process validation protocols.• Co-ordination with third party contractors and clients as required.• Maintaining cGMP procedures and protocols with Qualified Person.• Specific project management responsibilities for client projects as necessary, (including investigation and reporting on deviations, preparation of summary development reports).• Scheduling process and validation activities for client projects. • Member of company audit team attending regulatory (Irish Medicines Board) and client audits.• Hosted many tours and discussions of GMP facility with Biopharma clients.• Strategic planning and implementation of disposable processing capabilities at BioUetikon.• Liaising with suppliers and contractors to define processing solutions.• Guest speaker at local and international conferences.

Dublin, Ireland

• Execution of commercial scale liquid chromatography and filtration processes• Development of purification strategies for glycoproteins and monoclonal antibodies• Generation of process documentation, batch records and trending documents • Dissemination of results to senior management and customers

Department of Industrial Microbiology - 2 yrsDepartment of Food Science - 2 yrsDepartment of Biochemistry - 2 yrs

Phd, Biochemistry

Bsc (Hons), Biochemistry