Experience

F-star Therapeutics, Inc.

• VP, CMC

  • Mar 2021 - Present

• Senior Director, CMC

  • Jul 2020 - Mar 2021

  • Leader of CMC function for all aspects of the development and manufacture of mAbs and mAb-like molecules.• Responsible for clinical supply strategies aligned with Clinical Development Plans.• Responsible for outsourced Drug Substance & Drug Product manufacture to support development of clinical pipeline. • Responsible for CMC sections of regulatory submissions and communications.• Line management; responsible for recruitment, mentoring, staff appraisal and objective setting.

• Director, CMC

  • Jun 2018 - Jul 2020

  • Scientific, technical and project leadership for all aspects of CMC development leading to successful IND filings and clinical material supply.• Responsible for outsourced Drug Substance & Drug Product manufacture to support development of clinical pipeline. • Responsible for clinical supply strategies aligned with Clinical Development Plans. • Responsible for CMC sections of regulatory submissions and communications.• Support QA oversight of CMC activities.• QA/technical audits of external providers. • Line management; responsible for recruitment, mentoring, staff appraisal and objective setting.

• Principal Scientist, CMC Lead

  • Mar 2016 - Jul 2020

  • Scientific leadership of process development, technology transfer and CMO-based manufacturing of lead programmes in preclinical to phase I/II development.• Managing deployment and logistics of outsourced CMC activities with an emphasis on maintaining timeline and budget.• Contributing to preparation of regulatory applications (IND modules, briefing packages).• Responsible for CMC activities related to early development and candidate selection.• Contributing to drug discovery by leading manufacturability assessments of preclinical candidates.• Line and matrix management.

• Principal Scientist, Acting Head of Protein Sciences

  • Sep 2015 - Mar 2016

  • Development and implementation of the Group strategy for growth, ensuring protein production and characterisation needs of all R&D pipeline was met.• Accountable for protein supply to all discovery and preclinical development projects.• Engagement with CMO for lead programme manufacturing. • Responsible for CMC activities related to early development and candidate selection.• Line and matrix management

• Principal Scientist

  • Mar 2015 - Mar 2016

  • Protein Sciences team leader, accountable for meeting protein production and characterisation needs of the pipeline projects. • Manage the Protein Sciences resources and liaise between project leaders and CMOs to ensure the timely delivery of protein materials required to achieve the corporate goals.• Responsible for CMC activities related to early development and candidate selection.• Line and matrix management.

• Senior Scientist

  • Apr 2014 - Jun 2015

  • Project leader for a protein engineering project (loop grafting).• Team leader for Protein Sciences, accountable for material supply for all pipeline projects (managed resources and liaise between project leaders and CROs to ensure the timely delivery of protein materials).• Development of a corporate ADC strategy.• Line and matrix management.

• Scientist

  • Apr 2013 - Mar 2014

  Project manager for portfolio of ADC projects (several PoC collaborations with external partners).• Liaised with ADC partners and TSB board to achieve successful grant completion, organised and chaired meetings, generated minutes, decision logs and action logs.• Management of Project budget on a quarterly basis, and maintenance of active Project plans (using MS Project) and Risk Registers.• Provided analytical characterisation support to IND submission (designed and executed supplementary work plans, directed CRO efforts, authored technical reports).• Line management.

• Post-Doctoral Research Fellow

  • Mar 2013 - Jun 2013

  • Optimised lab-scale protein production. • Provided expertise in lead molecules characterisation utilising HPLC, SDS-PAGE and other standard analytical methodologies.• Instated in-house sequence liability screening for lead molecules.


University of Cambridge
• United Kingdom
• Research Services
• 700 & Above Employee
• Post-Doctoral Research Associate

  • Jan 2010 - Mar 2013

Newcastle University
• United Kingdom
• Higher Education
• 700 & Above Employee
• Post-Doctoral Research Associate

  • Jun 2008 - Dec 2009