BioPhorum is the biopharmaceutical industry’s most trusted collaborative network for change. BioPhorum is a collaboration of industry leaders and subject matter experts working together to pool knowledge, best practice, and ideas – these outputs lead to results that effect real progress. Our mission is to create an environment where our members from the global biopharmaceutical and device industries connect, collaborate and accelerate progress – for the benefit of all.I leverage my expertise in facilitation techniques and utilize diverse tools and technologies to facilitate workstreams within the Pharmaceutical and Biologics industry. This includes spearheading initiatives such as publishing best practice guides, position papers, podcasts, benchmarking surveys, and hosting webinars to drive problem-solving and innovation.Within the Fill Finish Phorum, I oversee the following programs of work:*Annex 1-Aseptic Process Solutions*Container Closure Systems*Visual Inspection

As Manager of Project Management at the Grangemouth site, I was an integral member of the Site Leadership Team governing the strategic direction of the site and ensuring the smooth delivery of daily site operations and project completion. I had direct line management responsibility for the site Senior Project Managers, Project Managers and in-direct oversight of the Business Operations Manager and team through matrix-based reporting.• Managed the Project Management team in performance and collaboration within cross functional operations to align and achieve targets and goals across client delivery.• Provided coaching, mentoring and direction to Project Management and Business Operations team.• Responsible for ensuring the correct management and delivery of client communication and I was responsible for internal and external client and project delivery escalation.• Worked closely with the Global Customer Centricity team to have oversight and control of the Customer Satisfaction Survey timelines and ownership of client response and escalation.• Supported site capacity planning alongside site leadership team and operations.• Supported the Global Business Development Managers in securing key client relationships and visits to site with the purpose of securing long term business. • Generated and provided weekly KPI metrics across Business Operations and Project Management.• Proactively monitored financial goals against delivery of project milestone• Supported and led the continuous improvement of systems and processes in line with current business functions, at site and corporate levels in collaboration with fellow Global Program Management Leads.• Contributed to and led site Sales and Operational Planning reviews.• Actively participated and co-led site Business Review meetings and client steering committee meetings.• Implemented and supported change and harmonisation across site and within global project management processes.

Q2 Solutions provides comprehensive global central laboratory services supporting clinical trials in countries around the world.Reporting to the Director of Customer Services I lead a large team of Clinical Project Managers in the management and execution of clinical trails within the EMEA region. Working closely with the Project Management team and Strategic Alliance Director I was responsible for providing dedicated senior level oversight accountable for Project Management governance for a key client of the business.

I rejoined BioReliance as a Senior Project Manager and was further promoted to the position of Custom Project Management Supervisor in August 2015. Reporting to the Senior Manager of Program Management I specialize in process development and GMP production for cell banking and viral programs for clinical trials. As part of my Supervisory role I also manage Viral Clearance and Custom Study Project Management activities across all UK sites.I am Program Manager for the largest client for BioReliance managing a multi-million, multi-site account, covering custom projects and managing routine batch manufacture of a viral product for commercial supply, including coordination of batch release and characterization testing over multiple testing sites. As part of my remit I also manage a number of ‘Elite’ clients who have a complex range of testing requirements, from routine to custom projects.I hold responsibility for manufacturing revenue forecasting and review of project workstreams through the department. A key focus of my role is also to develop relationships with clients during proposal discussions to allow me to manage their programs from business concept through to clinical trial release while working to establish external third party collaborations where required. Within my Supervisory role I coach and develop Project Managers within my team to allow them to develop the skills and business knowledge to execute routine and custom projects for the company. As part of the Senior Project Management team I also play a key role in directing best practice for the UK Project Management teams.

Reporting to the Senior Manager of Project Management, I held the position of Senior Project Manager and I was responsible for providing leadership to a team of eight Project Managers. Within the role my core function was to identify process improvements; leading inter-departmental and cross-departmental teams to deliver on goals identified. I assured on-time and correct completion of financial activities associated with projects managed by my team and worked to actively manage capacity. I was also responsible for developing and maintaining good business relationships with existing and new clients.Within my daily duties I ensured that my team was fully trained and capable of undertaking required activities associated with global full service and storage and distribution studies. I managed the performance of my team and supported my Managers in proactive and reactive situations. My administration duties required me to maintain effective metrics that monitored on-time delivery of clinical supplies both packaged and delivered to site. Through liaisons with Finance I provided monthly financial forecasts, revenue backlog and recognition of revenue according to the financial calendar for my own and my teams studies.

Reporting to the Team Leader of Program Management, I held the position of Senior Project Manager and I was responsible for a number of projects within a single division including customised and/or complex projects. I managed up to approx 20 clients, which presented projects of differing complexity and scale. A typical mix of projects could include 4 phase II clinical manufactures, 3-4 cell banking and/or Viral Seed Stocks projects and up to 10 routine testing clients at any given period. If any project was part of a larger programme, I was responsible in my role for ensuring information is shared with the Program Manager and the project proceeds to meet the timelines and specifications of the programme. I was also responsible for establishing and directing project teams within their own division and directing the work to meet the requirements set out in the project scope and for managing the budget of work under the specific project area. One of the distinguishing elements of this position was that as a Senior Project Manager I was responsible solely for a technical subject matter. My expert domain was GMP Manufacturing and I was the Lead Senior Project Manager for this area and managed the projects within that division. I also owned project components for PD Direct, which was a division of Invitrogen that was managed as a project partnership with BioReliance. As the Lead Senior Project Manager for manufacturing I also acted as an ambassador for the department and represent the groups in internal company meetings.

I joined Intercell Biomedical as one of 10 core team members that was retained during the receivership of Excell Biotech in February 2004. My initial role within Intercell Biomedical was Senior Scientist within Assay Development and Validation. My specific duties were to oversee the technical transfer of assays from international external sources, carry out and coordinate assay validation studies as applicable for the internal projects and to assist in technology/process development programs as required; this included the preparation and execution of study protocols and preparation of final SOP’s for Quality Control purposes. Full reports were written and submitted as appropriate, and further laboratory and project tasks were undertaken as detailed by line management structure. Within my role as a Senior Scientist I also undertook the duties and responsibilities of the ‘Head of Assay Development and GMP Compliance’ in their absence. As the company moved forward a major activity was managing the stability studies for all the development and clinical lots within the company. This was a significant undertaking, for which I was given the role of Stability Coordinator and given the responsibility for planning and scheduling stability testing for development, clinical and placebo batches. This involved working closely with both manufacturing to coordinate the availability of batches, with Quality Assurance to organise stability SOP's, protocols and reports and externally to manage shipping and testing at contract testing houses and at Intercell Vienna. I also liaised with Quality Control scientists who retain responsibility for scheduling the testing activities within Intercell’s QC labs and Study Directors in both Livingston and Intercell Vienna to ensure regulatory requirements are met to support the use of drug product in the phase 3 clinical studies and for commercial manufacture.

I joined Excell Biotech as a Purification Development Group Leader, this later developed into the role of Purification Area Supervisor during company restructuring. My role further progressed to a more senior technical role during the execution of a large project from development to GMP, leading a team of 6 scientists during product purification and assay development support. During this work I was the main technical contact for the client and reported frequently through technical discussions, writing of development plans and reporting during external and internal meetings. I was responsible for the technical transfer of incoming projects and successfully adapted the projects from academic level to large-scale pre-GMP manufacturing. I was able to make significant improvements to the projects by troubleshooting problem areas and successfully sourcing alternatives to current methods and improvements where appropriate. I spent a lot of my time liaising with suppliers who could provide me with alternative methods and products and I have since expanded my own knowledge on new technical advances within my field.

I joined Lonza Biologics Plc as a member of the Viral and DNA Validation team. My specific duties were to carry out GMP/GLP viral and DNA clearance studies for Phase 3 and Phase 4 product material and to assist in technology /process development programs as required; this included the preparation and execution of study protocols and preparation of SOP’s. Further duties included reviewing and commenting on external contractor’s documentation (for example protocols and reports) and to ensure all data was appropriately recorded, cross-referenced and laboratory notebooks were signed off in a timely manner. I was able to work with a group involved in the trial and implementation to GMP standard for new technical advances and software, this allowed me to work with many unknown areas in my field and successfully implement these into my work. Where required, full reports were written and submitted as appropriate, and further laboratory and project tasks were undertaken as detailed by line management structure. In addition I was frequently involved in discussing project requirements with the customer directly and I attended and presented data as appropriate at customer meetings.