A member of Labcorp Drug Development's Scientific Affairs team, partnering with clients, internal staff and external collaborators to address science, technology and regulatory challenges. A primary area of focus is bioanalytical strategy supporting clinical and nonclinical studies, including pharmacokinetic, pharmacodynamic, biomarker and immunogenicity endpoints.

Lectures in the Biopharmaceutical Development MSc program on measurement and interpretation of pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity.

Lectures in the Certificate in Industrial Life Sciences (CILS) program on measurement and interpretation of pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity.

A member of Covance’s Scientific Affairs team, partnering with clients, internal staff and external collaborators to address science, technology and regulatory challenges. A primary area of focus is bioanalytical strategy supporting clinical and nonclinical studies, including pharmacokinetic, pharmacodynamics, biomarker and immunogenicity endpoints.

Working for EmaCo SA, a subsidiary of Sobi, after acquisition of the emapalumab business from Novimmune.Role focused on bioanalytical science regulatory affairs for US and European registration of a monoclonal antibody therapeutic, including hosting of a regulatory inspection of the bioanalytical laboratory.

- Responsibility for the delivery of bioanalytical data by the Bioanalytical Science Section and CRO partners, including pharmacokinetic (PK), pharmacodynamics (PD)/biomarkers and immunogenicity endpoints. - Bioanalytical Project Manager for PK, PD/biomarker and immunogenicity packages supporting clinical trial programs. - Scientific writing of preclinical/clinical bioanalytical reports, Investigator Brochures and regulatory documents in support of FDA and EMA submissions.- Responsible for ensuring GCP/GCLP compliance of bioanalytical work.- Study Monitor for CRO partners to ensure high quality bioanalytical data for geographically-dispersed sites. Primary point of contact for CRO partners. Lead scientific discussions. Work with management and coordination team for price negotiation and contracting.- Ensure appropriate bioanalytical assays are developed, transferred (as required) and validated within project timelines.- Work with management and coordination teams to ensure appropriate resource allocation.- Advancement of Companion Diagnostic (CDx) programs.- Line management, mentoring and career development responsibility for 12 Bioanalytical scientists. Company representative to European Bioanalysis Forum (EBF) and Drug Metabolism Discussion Group (DMDG). Member of the Research Quality Association (RQA), the American Association of Pharmaceutical Scientists (AAPS) and the Royal Society of Biology (RSB)

Developing, optimising and validating assays for testing of pre-clinical and clinical samples. Assay types include pharmacokinetic/toxicokinetic (PK/TK), immunogenicity/anti-drug antibody (ADA), neutralising antibody (nAb) and pharmacodynamic (PD)/biomarker. Platforms used include ELISA, Mesoscale (MSD), Gyrolab (Gyros), Luminex and AlphaLISA, in addition to cell-based assay systems. When appropriate, assays were outsourced to CRO partners, where I took a study monitor role for the transfer, validation and sample analysis activities.Group leader with line management and career development responsibility for 10 Bioanalytical scientists. Scientific writing of preclinical/clinical reports, writing and revision of bioanalytical sections of Investigator Brochures and regulatory documents in support of FDA and EMA submissions. Presentations at international conferences including:- EBF Open Symposium- AAPS National Biotechnology Conference (NBC) & PharmSci360- Annual Biomarker Congress- EBF Focus Workshops on immungenicity, biomarker and Pharma-CRO topics- Gyrolab User Seminar- Workshop on Recent Issues in Bioanalysis (WRIB)Led EBF Topic Team 61 Leader (non-parallelism in biomarker assays)

Senior Scientist role with additional responsibilities in leading, and promoting externally, the scientific expertise of the immunochemistry department. Responsible Analyst for key client partnerships and non-routine immunochemistry methods.Presentations at EBF Open Symposium (Barcelona, November 2011), Gyrolab User Seminar (Paris, June 2013).

Development, transfer, validation, troubleshooting, routine sample analysis and reporting of immunochemistry assays for detection of drug product (TK/PK), anti drug antibodies (ADA) and biomarkers (PD) within a regulatory compliant laboratory (GLP/GCP). Supervision and training of immunochemistry analysts.

Performing and supervising viral biosafety assays within a regulatory compliant laboratory (GLP/GMP).

Sales and equipment testing with a leading outdoor equipment specialist.

Volunteer work in the slums of Nairobi working in rehabilitation and counselling projects for street children.

Research at the Regenerative Medicine Institute (REMEDI) investigating the use of viral gene therapy to deliver RNAi constructs to inhibit gene expression in cardiovascular disease.

Short term contract continuing Ph.D. research.