Experience

MoonLake Immunotherapeutics (NASDAQ: MLTX)

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• QMS Manager

  • Aug 2023 - Present



Kymab Ltd

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Senior Clinical Trials Administrator

  • Jan 2020 - Apr 2022

  Responsible for driving and implementing eTMF upgrades and bug fixes, including user acceptance testing (UAT). Responsible for eTMF vendor management. Implemented quarterly review process of TMF for quality, completeness and timeliness. Supported internal and external clinical team members to conduct TMF reviews leading to improved TMF completeness. Generated TMF metrics for monitoring performance of CROs. Development of eTMF training material and delivery of training… Show more Responsible for driving and implementing eTMF upgrades and bug fixes, including user acceptance testing (UAT). Responsible for eTMF vendor management. Implemented quarterly review process of TMF for quality, completeness and timeliness. Supported internal and external clinical team members to conduct TMF reviews leading to improved TMF completeness. Generated TMF metrics for monitoring performance of CROs. Development of eTMF training material and delivery of training to in-house and CRO users. Supported Clinical Project Managers in trial administration activities e.g. QC checking of key clinical documentation, tracking key regulatory activities, updates to clinicaltrials.gov website. Line management responsibilities. Integration of Kymab clinical trial systems into Sanofi corporate systems e.g. eTMF, CTMS, insurance, out of hours medical cover, after acquisition.

• Clinical Trials Administrator

  • Apr 2018 - Dec 2019

  eTMF super user and in-house subject matter expert. Developed training materials for eTMF and delivered training. Administration of clinical trial team meetings. Maintained public registry for clinical studies, coordinated review by internal stakeholders. Supported internal audits, and worked with QA to close out audit findings.



abcam

• United Kingdom
• Biotechnology Research
• 700 & Above Employee

• Portfolio Development Associate | Portfolio & Business Development

  • Jan 2017 - Apr 2018

  Management of antibody pipeline for immunoassays (ELISA kits), prioritising projects to meet company strategies. Perform commercial review and co-ordinate technical review of new targets with R&D. Tracking antibody development for variety of immunoassay platforms. Super-user for Enterprise Resource Planning system (ERP) implementation (user acceptance testing, training)

• Product Coordinator | Kits and Assays Team, Marketing

  • Mar 2015 - Dec 2016

  Creation and maintenance of tracker to monitor immunoassay pipeline progress Development of tools to assess new targets for antibody pipeline Support of marketing activities e.g. web content creation, review of technical user manuals, proof-reading scientific marketing material

• Documentation Assistant (Short-term contract)

  • Nov 2014 - Mar 2015

  Revision and checking of > 150 assay user manuals. Improving content, format and quality of instructions for end users.



MedImmune

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Study Manager | Logistics and Clinical Supply

  • Jun 2014 - Oct 2014

  Project management of packaging, labelling and distribution requirements for drug supply (IMP) to support clinical studies. Included writing and approval of GMP documentation for vendors e.g. packaging summaries, label text, global distribution plans. Worked with CMOs, CROs and QA to achieve on-time delivery of drug supply to global clinical studies, including developing export/import strategies for different territories for drug and ancillary supplies. All drug supply… Show more Project management of packaging, labelling and distribution requirements for drug supply (IMP) to support clinical studies. Included writing and approval of GMP documentation for vendors e.g. packaging summaries, label text, global distribution plans. Worked with CMOs, CROs and QA to achieve on-time delivery of drug supply to global clinical studies, including developing export/import strategies for different territories for drug and ancillary supplies. All drug supply activities conducted according to applicable GMP and GCP regulations, with full, traceable documentation. Oversight of distribution activities and troubleshooting IMP issues e.g. cold chain excursions. Use of inventory control systems e.g. IXRS, SmartSupplies PMD. Provide compliance support for internal and external audits, SOP review and collaboration on CAPA completion. Competent user of Trackwise for non-conformance reporting. Completed internal training as "QA Lead Investigator" for non-conformance investigation, working collaboratively with QA to provide supporting evidence.

• Clinical Supply Specialist | Clinical Pharmacy Research Services

  • May 2010 - May 2014

  Responsible for co-ordinating and scheduling packaging/labelling activities. Writing and approval of GMP documentation (label content and design, packaging/labelling requirements) with vendors to meet "first subject in" dates and supply continuity for the study. Co-ordinating distribution of IMP to sites and depots to meet clinical demand, including use of IXRS. User acceptance testing of IXRS; execution of testing scripts Effective cross-functional team working, meeting… Show more Responsible for co-ordinating and scheduling packaging/labelling activities. Writing and approval of GMP documentation (label content and design, packaging/labelling requirements) with vendors to meet "first subject in" dates and supply continuity for the study. Co-ordinating distribution of IMP to sites and depots to meet clinical demand, including use of IXRS. User acceptance testing of IXRS; execution of testing scripts Effective cross-functional team working, meeting clinical project timelines for subject dosing e.g. shelf life extensions. Responsible for IMP returns and destruction, and persistent follow up to ensure 100% reconciliation with appropriate documentation. Ensured inventories of drug product (DP) and investigational medicinal supply (IMP) met predicted patient recruitment schedules. Experience of working on Phase 1 and 2 clinical studies in EU, APAC, US and Latam.

• Senior Quality Assurance Scientist (Senior QA Officer)

  • Jan 2005 - Apr 2010

  Review and approval of clinical trial packaging documentation, including label approval (multi-lingual), packaging orders, batch records Compilation of QA release documentation, and scheduling of QP release activities. Responsible for compiling multiple Product Specification Files, ensuring all information is current. Review of non-conformances that may prevent QP certification activities. Lead and co-lead auditor for GMP audits of 2 packaging/labelling vendors. Follow up of… Show more Review and approval of clinical trial packaging documentation, including label approval (multi-lingual), packaging orders, batch records Compilation of QA release documentation, and scheduling of QP release activities. Responsible for compiling multiple Product Specification Files, ensuring all information is current. Review of non-conformances that may prevent QP certification activities. Lead and co-lead auditor for GMP audits of 2 packaging/labelling vendors. Follow up of external audit observations, and providing metrics for vendor compliance/oversight. Project management and implementation of corporate-wide electronic quality management systems for training and SOPs. Writing, review and input into SOPs (cross-functional procedures), as well as delivering training. Co-ordination of inspection preparation activities for GMP and GCP MHRA inspections. Pro-active follow-up of inspection corrective actions. Line management of Quality Scientist. Deputy GMP archivist.



Cambridge Antibody Technology

• Biotechnology
• 1 - 100 Employee

• Quality Assurance Scientist (QA Officer)

  • May 2003 - Dec 2004

  Established and maintained GXP compliant quality systems including documentation, training, deviation systems, supporting QC, Regulatory, Clinical, Clinical Assay functional groups. Delivery of GXP induction training, as well as QA procedural training. Provided metrics and trending of quality systems e.g. non-conformance close out, category trending Technical review and approval of non-conformances Responsible for GMP archive, including working with Facilities group… Show more Established and maintained GXP compliant quality systems including documentation, training, deviation systems, supporting QC, Regulatory, Clinical, Clinical Assay functional groups. Delivery of GXP induction training, as well as QA procedural training. Provided metrics and trending of quality systems e.g. non-conformance close out, category trending Technical review and approval of non-conformances Responsible for GMP archive, including working with Facilities group to secure additional fire-proof archiving. Provided recommendation to senior management for new off-site archive vendor for scientific and regulatory archiving. Key participant in organising company-wide "paper-clean up" day, creating guidelines and advice on documentation requiring archiving.

• Research Scientist

  • Nov 1999 - Apr 2003

  High throughput phage antibody selection and screening against multiple targets, requiring cell culture and purification techniques Co-ordinated work for the team on day-to-day basis, liaised with other functional groups to ensure that samples and data and delivered on time Authored SOPs, contributed to training manual and introduced reagent batch numbering system Responsibility for collating data and maintaining project records and report data Promoted from Grade… Show more High throughput phage antibody selection and screening against multiple targets, requiring cell culture and purification techniques Co-ordinated work for the team on day-to-day basis, liaised with other functional groups to ensure that samples and data and delivered on time Authored SOPs, contributed to training manual and introduced reagent batch numbering system Responsibility for collating data and maintaining project records and report data Promoted from Grade II to Grade III - Nov 2000



Axis Genetics

• Cambrige, UK

• Research Scientist

  • Feb 1998 - Sep 1999

  Design, development and validation of new cell and serological assays e.g ELISPOTs, ELISAs, T-cell proliferation, proof of principle cytotoxic T cell assays. Design, development and validation of new cell and serological assays e.g ELISPOTs, ELISAs, T-cell proliferation, proof of principle cytotoxic T cell assays.



Papworth Hospital

• Cambridge, United Kingdom

• Biomedical Scientist Grade 2

  • May 1995 - Feb 1998

  Managed the day-to-day running of immunopathology lab supporting Lung Defence Clinic Provision of T-cell monitoring service (including on-call weekend service) for heart and lung transplant unit Performed variety of cellular and serological assays including neutrophil function tests, flow cytometry, ELISA on patient blood samples Creation of lab SOPs for lab assays/tests and reagent formulation Trained more than 6 personnel (including biomedical scientists and research fellow) to… Show more Managed the day-to-day running of immunopathology lab supporting Lung Defence Clinic Provision of T-cell monitoring service (including on-call weekend service) for heart and lung transplant unit Performed variety of cellular and serological assays including neutrophil function tests, flow cytometry, ELISA on patient blood samples Creation of lab SOPs for lab assays/tests and reagent formulation Trained more than 6 personnel (including biomedical scientists and research fellow) to use 3-colour flow cytometer Show less Managed the day-to-day running of immunopathology lab supporting Lung Defence Clinic Provision of T-cell monitoring service (including on-call weekend service) for heart and lung transplant unit Performed variety of cellular and serological assays including neutrophil function tests, flow cytometry, ELISA on patient blood samples Creation of lab SOPs for lab assays/tests and reagent formulation Trained more than 6 personnel (including biomedical scientists and research fellow) to… Show more Managed the day-to-day running of immunopathology lab supporting Lung Defence Clinic Provision of T-cell monitoring service (including on-call weekend service) for heart and lung transplant unit Performed variety of cellular and serological assays including neutrophil function tests, flow cytometry, ELISA on patient blood samples Creation of lab SOPs for lab assays/tests and reagent formulation Trained more than 6 personnel (including biomedical scientists and research fellow) to use 3-colour flow cytometer Show less



Heatherwood and Wexham Park Hospitals NHS Foundation Trust

• United Kingdom
• Hospitals and Health Care
• 400 - 500 Employee

• Biomedical Scientist Grade 1

  • Jan 1992 - May 1995

  Analysis of serum samples for autoantibodies, inflammatory protein marker analysis, gel eletrophoresis Analysis of serum samples for autoantibodies, inflammatory protein marker analysis, gel eletrophoresis