Lee Smith

Principal Consultant & Director @Greyrigge Associates

Reading, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2010 — Present

Principal Consultant & Director @Greyrigge Associates

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GRA | The Biotech Consultancy A life-science consulting organisation that assists both small and large companies globally, both technically and commercially, by bringing expertise, ideas, experience and training into biopharmaceuticals and diagnostics sectors. Technical activities include- Process development, optimization and validation for biotech products- Optimization, Qualification and validation of analytical methods including bioassays- Optimization, Qualification and validation of pre-clinical and clinical assays- Product characterization strategy and execution- Lyophilization optimization- Contractor selection and management (CMOs & CROs).Commercial activities include- Assisting with funding activities, both equity based and grants- Identifying and negotiating with business partners, including in licensing- Managing business & marketing strategies including arranging trade shows- Conference and trade show attendance - Board level interactions, including advisory, reporting and due diligence- Business development and marketing activities.

EDUCATION

1989 — 1993

University of the West of England

B.Sc. (Hons), Biotechnology

1993 — 1997

University of Bath

Ph.D., School of Biology & Biochemistry

1991 — 1992

University of Cincinnati

1 yr scholarship, Cell Biophysics

SKILLS

ManagementTeam BuildingManufacturingR&DMedical DevicesClinical ResearchCancerBiopharmaceuticalsHealthcareBusiness DevelopmentBusiness PlanningMonoclonal AntibodiesStrategy DevelopmentBusiness StrategyPharmaceutical IndustryFdaMolecular BiologyIntellectual PropertyRegulatory SubmissionsProgram ManagementVaccinesOncologyDiagnosticsBiochemistryInfectious DiseasesDue DiligenceStrategyProduct DevelopmentTechnology TransferClinical TrialsNew Business DevelopmentPharmaceuticalsValidationMarketing StrategyHardware DiagnosticsRegulatory AffairsLifesciencesProcess DevelopmentStrategic PlanningNegotiation

ABOUT LEE SMITH

GreyRigge Associates is a leading biotech consultancy partner with sites in both the UK and USA, bringing biopharmaceutical development experience. We offer both consultancy support as well as industry training services.I have over 30 years of industry experience in the life sciences, having worked in the life sciences since the early 1990’s, as well as being a seasoned consultant since 2010. My passion is to help in the development of medicines. I assist companies in helping them succeed through guiding a product’s development to ultimately achieve successful clinical trials, licensure and business growth. My industrial experience is broad and spans both technical and commercial. This includes R&D, Product Development, Pre-Clinical Development, CMC, Formulation, Regulatory Affairs support, Program Management, Business Development as well as Sales & Marketing. I focus upon data driven results, and support small start-up, mid-sized SMEs as well as large multinational companies and corporations, bring commercial, operational, and technical expertise. If you are- a biopharmaceutical company looking for consultancy support or training, please contact us to see how we can help support you- an experienced consultant open to freelance opportunities and could apply your expertise for GRA clients then please connect with us.

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Lee Smith — Principal Consultant & Director at Greyrigge Associates in Reading, GB | Unifers