Jon Marshall Email & Phone Number

Clackmannan, Gb

Glasgow, Scotland, United Kingdom

Scotland

Consulting, contract and interim management for Biopharmaceutical companiesCOMMON ISSUES AND CHALLENGES • Maintaining high client service levels in an increasingly competitive outsourced marketplace• Building long-term client relationships for stable revenue performance• Reconciling increasing client, regulatory (EU/FDA) and commercial requirements in a competitive market• Ensuring all your resources are focussed on adding value and not just a costTHE BENEFITS OF USING TULACH• Leverage industry experience for improvement without diverting valuable internal resource• Insight to enhance your client service levels• Benefit from cross-functional experience to facilitate your projects and initiatives• Analytical and pragmatic guidance in balancing compliance and cost in a highly regulated environment

Edinburgh, United Kingdom

Moredun Scientific is the commercial arm of the Moredun Foundation, a registered charity that exists to promote the highest possible standards for animal health and welfare through research and education. The Foundation supports a broad and varied range of research initiatives within the Moredun Research Institute. Any profit generated by Moredun Scientific, not retained for re-investment, is transferred on an annual basis to the Moredun Foundation, which in turn uses the funds to help support research programmes.Contract research services to the Animal Health industry have traditionally constituted our main business, concentrating mainly on efficacy and safety studies in livestock. All work is completed to Good Laboratory Practice (GLP) or Veterinary Good Clinical Practice (VICH-GCP).We have completed over 300 studies for the animal health industry and count many of the top 20 global animal health companies amongst our clients.In 2008 we successfully launched our Biosafety Testing business supporting the biopharmaceutical industry through the provision of high quality testing services to GLP or Good Manufacturing Practice (GMP) in accordance with international regulatory requirements.

Slough, United Kingdom

Fixed term contract managing biochemistry team performing CE SDS, icIEF and SDS PAGE GMP release assays on clinical and licensed monoclonal antibodies. Change management of QC Lean Lab process to reduce lead times, increase capacity and improved right first time performance.

Edinburgh, United Kingdom

Fixed term contract managing quality control group (serology, biochemistry and microbiology) for manufacturer of transfusion diagnostics.• Managed group to execute high volume raw material, intermediate and final product GMP testing and Environmental monitoring services (4000+ samples/month)• Managed transition of teams from legacy facility to purpose built manufacturing facility whilst maintaining continuous QC services• Participation in two FDA audits (PAI for new facility and surveillance audit for existing facility)

Edinburgh, United Kingdom

Providing interim management services to Roslin Cell Therapies in managing their GMP Stem Cell manufacturing group.

Edinburgh, Uk

Responsible for two operating divisions providing GMP lot release testing to worldwide biopharmaceutical clients engaged in product development through to licence product release. Achievements in role included:• Leading role in evaluating and acquiring major European competitor• Leading cross-function and cross-site team to integrate service delivery across five separate sites (US and Europe)• Project sponsor for cross-site IT projects (LIMS/eLN)

Responsible for leading process improvement initiatives resulting in improvements in quality, cost and service for the European business. Projects included global service Harmonisation, LIMS/eLN and ERP systems. Achievements in role included:• Led team on UK/US service Harmonisation across multiple UK/US sites• Championed and trained staff in collaborative IT tools (Live Meeting, collaborative intranet)• Developed skills in Lean Six Sigma

Upon acquisition of major competitor (Q1 Biotech) became responsible for clinical trial manufacturing groups of both companies (staff of 27, including two manufacturing directors and a dedicated project management group). Part of the senior management team responsible for European and Rest of World business (total staff in excess of 300 across three UK sites). Achievements in role included:• Rationalised two manufacturing teams into one facility location (without staff loss)• Obtained IMP manufacturing licence from MHRA

With promotion of one of my staff to senior management team took on responsibility for Analytical Services (a new service area) in addition to Phase I/II manufacturing services (staff of two managers, three supervisors and eleven technical staff). Responsibilities included (in addition to those held previously):• Recruitment and business development of Analytical Services group• Consultancy services for clientsAchievements in role included:• Led team in preparation of business plan and facility specification/design for a new GMP clinical trials manufacturing unit ($3m capital spend) and won board approval• Won large routine lot releasing contract for licensed biopharmaceutical

Promotion to European senior management team with responsibility for three operating groups (clinical trial manufacturing, viral clearance and central support) accounting for majority of revenue generating operations at Stirling facility (staff of three managers and twenty technical staff).

Launch, development and management of clinical trials manufacturing services (gene therapy and other biopharmaceuticals for European and US clients ranging from ‘start up’ biotech companies to multi-nationals). Reported directly to the Vice President for Europe and responsibilities included: • Management of operations (P&L accountability, business planning and budgeting)• Recruitment and development of staff• Extensive client contact (closing sales, client audits and visits)• Presentations at conferences and preparation of marketing/technical materialsAchievements in role included:• Built business division from ‘one-man’ operation to profitable concern• Successful MCA inspection (twice) for GMP clinical trials manufacturing• Built client base across Europe, US and Far East

Promotion in recognition of increased project responsibilities working in a 'matrix management' environment. In addition to 'non-project' responsibilities (administration of departmental computer network, sandwich student liaison, departmental resource planning team) involved in a wide variety of project teams. Achievements in role included:• design of new development facility including analytical laboratories and cGMP pilot plant for clinical trials batch manufacture (£1.8m capital spend)• Wellcome Biotech project leader (co-ordination of multiple project teams for transfer of facilities, processes and licensing of vaccines into Speke site). Presentation of key project issues to Board members.• Tetanus vaccine transfer project leader. Design of improved manufacturing process and primary production facility.• Development member for computer Aided New Product Applications (CANDA) project.

Responsibilities included process development for new (and existing) biological products (vaccines) and evaluation of new technologies for vaccine production and testing.

Supervision of a collaborative project with the MRC AIDS directed programme (ADP) reagent project.

Research and development of a subunit vaccine for Bluetongue virus and the study of viral morphogenesis. This involved a wide variety of molecular biochemical, virological and immunological techniques.

Diabetes research on insulin gene expression funded by the British Diabetic Association. Biochemistry laboratory demonstrator and teaching Pascal programming.

Phd, Biochemistry

Thesis title: 'Regulation of Insulin Gene Expression in Rat Islets of Langerhans'.

Bsc (Hons), Biochemistry

Thin sandwich course with two industrial placements (MAFF, Weybridge, Surrey & Rockefeller University, New York)