Lee founded GRA and has a passion for biotech & data driven results. GRA’s aim is to help companies, or more specifically, their people drive programs forward, achieve objectives and grow the business.
Skills include:
- Product Development: Has worked in senior roles on a variety of IMPs for infectious disease, oncology and cardiovascular disease, including over 20 developmental vaccines. Has worked closely with clinicians in performing trials and manage multiple international CROs & CMOs.
- Technical Expertise: A ‘hands-on’ individual with experience in biopharmaceutical sector including R&D, product development & characterisation, manufacturing & clinical development on both early and late-stage products.
- Compliance: Experience of working in GxP, HACCP and ISO environments for both development and manufacturing to European, American and ASEAN standards.
- Regulatory: Familiarity with FDA, EMA & MHRA regulations for medicines including dossier submissions, BLAs and regulatory interactions.
- Training: Has performed training internationally on CMC related activities including process, formulation, analytical development and QbD for a variety of organisations.
- Corporate & Financial: Responsibility for budgeting, P&L and balance sheet. Management of board meetings. Have previously been responsible for over 80 staff. Good VC network.
- Business Strategy: Review of revenue generation strategies to improving both the top and bottom lines through business development and operational adjustments. In licencing activities & supporting patent filings.
- Project Management: Demonstrated ability to manage projects and programmes to ensure forward momentum and value addition. Managed collaborations and relationships with industry, academia, regulatory bodies and NGOs
