Donna Dobinson

MedPharm Ltd at MedPharm Ltd
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London, England, United Kingdom, UK

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Experience

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Planning Director
      • Jan 2023 - Present

    • Director of Resource Management
      • Sep 2018 - Jan 2023

    • Director of Pharmaceutical Analysis
      • Nov 2015 - Sep 2018

    • Director of Pharmaceutical Operations
      • Nov 2014 - Nov 2015

    • Manager of Pharmaceutical Development
      • Nov 2013 - Nov 2014

    • Head of Pharmaceutical Analysis
      • Jan 2013 - Oct 2013

      Guildford

    • Deputy Head of Pharmaceutical Analysis
      • Aug 2012 - Jan 2013

      Guildford, United Kingdom

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Scientist
      • Sep 2010 - Jul 2012

      •Regular contributor to project teams and adept to working with colleagues across different disciplinesand levels of management •Strong planning, time management and organisational skills with initiative and attention to detail •Proficient technical writer with sound understanding of bioanalytical regulatory requirements • Senior Scientist for the method setup, validation and sample analysis of internal research projects and external client projects • Home Office Personal Licence… Show more •Regular contributor to project teams and adept to working with colleagues across different disciplinesand levels of management •Strong planning, time management and organisational skills with initiative and attention to detail •Proficient technical writer with sound understanding of bioanalytical regulatory requirements • Senior Scientist for the method setup, validation and sample analysis of internal research projects and external client projects • Home Office Personal Licence holder, modules 1-4. Assisting in pharmacokinetic, biodistribution and drug exposure studies in rodents • Writer of technical bioanalytical documentation for inclusion in external contractor study reports • Member of the BMSS Show less

    • Senior Research Scientist
      • Nov 2008 - Sep 2010

      •Effective and efficient manager of outsourced GLP bioanalysis for Phase II/III clinical products •Regular contributor to project teams and adept to working with colleagues across different disciplines, time zones and levels of management •Strong planning, time management and organisational skills with initiative and attention to detail •Proficient technical writer with sound understanding of bioanalytical regulatory requirements •Proactive leader in the design, conduct and… Show more •Effective and efficient manager of outsourced GLP bioanalysis for Phase II/III clinical products •Regular contributor to project teams and adept to working with colleagues across different disciplines, time zones and levels of management •Strong planning, time management and organisational skills with initiative and attention to detail •Proficient technical writer with sound understanding of bioanalytical regulatory requirements •Proactive leader in the design, conduct and interpretation of pharmacokinetic and drug metabolism studies for screening and profiling of small molecules across multiple drug development projects • Lab supervisor and lead analyst for the method setup, transfer and overseeing external GLP validation of small molecules and oligonucleotides • Auditing GLP bioanalytical facilities and data generated • Home Office Personal Licence holder, modules 1-4. Responsible for pharmacokinetic, biodistribution and drug exposure studies in rodents • Lead scientist, managing a small team for method development and validation for small molecule and oligonucleotide oncology drugs to support toxicokinetics, pharmacokinetics and metabolite identification • Manage the outsourcing of GLP bioanalysis tasks taking a proactive role through facilitation of CDA’s selection and negotiation of proposals, revision of protocols and management of deliverables • Auditing external CROs for facility and bioanalytical data GLP compliance • Holder of a Home Office personal licence and actively involved in the design and conduct of pharmacokinetic, MTD and MRD studies in accordance with Animal Use Policies and project licences • Writer of technical DMPK documentation for inclusion in regulatory submissions and external contractor study reports • Involved in the in vitro DMPK studies within the lab and reporting back through various pre-clinical and non-clinical project meeting internally and to external collaborators • Member of the BMSS and AACR

    • Research Scientist
      • Nov 2005 - Nov 2008

      • Develop and validate methods for analysis of Antisoma’s drug portfolio. • Conduct pharmacokinetic studies for candidate drugs in conjunction with other team members. • Conduct solubility assessments for candidate drugs. • Conduct single dose and repeat dose MTD studies for candidate drugs in conjunction with other team members. • Provide technical support for in vivo studies to include key competencies such as seeding tumours and administration of drugs via various… Show more • Develop and validate methods for analysis of Antisoma’s drug portfolio. • Conduct pharmacokinetic studies for candidate drugs in conjunction with other team members. • Conduct solubility assessments for candidate drugs. • Conduct single dose and repeat dose MTD studies for candidate drugs in conjunction with other team members. • Provide technical support for in vivo studies to include key competencies such as seeding tumours and administration of drugs via various routes. • Deliver project objectives on time. • Attend and participate in lab meetings. • Keep up with the relevant literature. • Comply with relevant SOPs and recommend updates and improvements as necessary. • Compile scientific reports to appropriate standard. • Ensure documents are issued in timely manner in accordance with company policy.

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Study Director
      • May 1998 - Nov 2005

      • Monitor and control the testing and documentation activities of the laboratory analysts • Assemble, review and approve report documentation for release to external sponsors • Draft, update and review SOPs in accordance with site and GLP requirements • Create and approve analytical and validation protocol records as per sponsors specifications • Monitor laboratory facilities and procedures to maintain GLP, UKAS compliance and biological and chemical safety regulations… Show more • Monitor and control the testing and documentation activities of the laboratory analysts • Assemble, review and approve report documentation for release to external sponsors • Draft, update and review SOPs in accordance with site and GLP requirements • Create and approve analytical and validation protocol records as per sponsors specifications • Monitor laboratory facilities and procedures to maintain GLP, UKAS compliance and biological and chemical safety regulations (COSHH) • Prepare own laboratory work schedule • Oversee completion of laboratory investigation reports by laboratory analysts • Design, develop, validate and perform analytical assays as requested by an external sponsor • Maintain an accurate record of experiments in a laboratory notebook • To maintain an efficient archive for all data generated by myself. • To undertake several projects simultaneously as a Study Director within GLP guidelines • To effectively communicate with sponsors and superiors on the progress and results of work undertaken • GLP Compliance Officer • To perform quality assurance audits of specific studies when requested • Operation and maintenance of gas chromatographs, mass spectrometers, liquid chromatographs, data systems and other equipment • Initiate purchase of consumable items • Generate invoices, manage filing and accounting systems to help maintain the financial accounts of the company • Operation and maintenance of PC workstations and their associated software, including Chemstation, NuGenesis Archive, NuGenesis UNIFY Vision and Microsoft Office Show less

    • United Kingdom
    • Veterinary Services
    • Student Placment
      • 1995 - 1996

Education

  • University of Surrey
    Bachelor of Science (BSc), Biochemistry (Toxicology)
    1993 - 1997
  • Croydon College
    1991 - 1993

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