Emma Michael

Senior Programme Manager with 5+ years' experience leading complex, multi-million-pound CMC GMP delivery programmes across global biopharma, biotech and IVD companies, often as the sole point of contact for international clients and C-suite stakeholders. Combines hands on analytical development experience in gene therapy process characterisation with proven CDMO coordination, tech transfer execution, and GMP compliance expertise across 25+ global programmes. Delivered programmes (£1M–£3M each) across UK, US, and APAC, achieving 100% on time milestone delivery across complex tech transfers, and time zone dependencies.

Led on internal AI and automation initiatives (Smartsheet, Power Automate) that cut handover time by 75% and reduced repetitive admin by 5+ hours/week per PM. Now seeking a Programme Manager or Delivery Leadership role where strategic oversight, operational excellence, and client trust drive business outcomes. Demonstrated ability to transform biopharmaceutical projects by leveraging comprehensive experience across in cell and gene therapies, cell banking, formulation development and optimisation, compatibility and stability studies, method and process validation, vitro-diagnostics and regulatory affairs to drive compliant product development from early stage research through to market.

Senior Programme Manager - Abingdon Health - York, UK and Madison, Wisconsin

(2026-02)

• Concurrently managing a portfolio of 5 programmes across 2 international sites (York, UK and Madison, Wisconsin), spanning early stage development through to device validation for lateral flow IVD products
• Serve as the primary client interface across all programmes, hosting regular client calls, disseminating technical and project information between external stakeholders and internal teams, and maintain a structure log of minutes, actions and risks
• Travelled internationally to strengthen client communication pathways and accelerate progress on a flagship programme, demonstrating commitment to relationship to relationship management at a senior level
• Manage programme finances end-to-end, including monthly financial reporting and active contribution to a companywide financial audit process, ensuring accurate and timely submissions
• Support clients operating under ISO regulatory frameworks ensuring programme delivery aligns with applicable standards from feasibility through IQ/OQ/PQ and V&V phases
• Pioneering the development of a formal programme management framework for the business, producing foundational documentation and standardised tools where no defined process previously existed
• Driving continuous improvement across delivery systems, including the design and implementation of structured reporting and tracking of mechanisms to increase programme visibility and governance

Project Manager II - Touchlight

(2025-01 - 2025-08)

• Owned end-to-end delivery for the world's largest enzymatic DNA manufacturing facility, acting as primary client interface for CEOs and technical leads across Europe, US, and APAC
• Redesigned chaotic handover process using Smartsheet automation, reducing handover time from 2 hours to 25 minutes per programme and enabling scalable onboarding during team growth
• Spearheaded AI adoption: piloted transcription tools to auto generate meeting minutes and action logs, saving 5+ hours weekly and eliminating post meeting bottlenecks
• Built dynamic project initiation toolkit (timeline templates, stakeholder maps, project initiation checklist), cutting new project ramp up time by 50% and ensuring GMP compliance from Day 1
• Managed full financial gatekeeping in SAP: linked technical milestones to invoicing triggers, ensuring revenue integrity while protecting client investment

Programme Manager - Fujifilm Diosynth Biotechnologies - UK, NC, Texas

(2021-07 - 2024-09)

• Led 15+ global programmes (4-14 concurrent, £1M–£3M each) across full lifecycle, from SoW drafting and contract negotiation to tech transfer (UK, NC, Texas), GMP manufacturing, and clinical trial handover, delivering 100% on-time milestones
• Driving the delivery for cell line and strain development, manufacturability assessments, cell banking and toxicology material generation for all programmes. Guiding customers on the path to IND/IMPD submission
• Served as an escalation point for CEO level client concerns (Korea, Europe, US); resolved critical path blockers within 48 hours through rapid cross site alignment and transparent risk communication
• Controlled milestone based financial releases: collaborated with Legal and Finance to tie payments to technical deliverables, mitigating revenue risk and ensuring contract compliance
• Translated complex scientific data into strategic business updates, building trusted advisor relationships by aligning client expectations with product yield realities and regulatory constraints
• Developed global PM playbooks (risk logs, onboarding guides, stage gate templates) adopted as companywide standards, improving team efficiency by 30%

Research Scientist - Fujifilm Diosynth Biotechnologies

(2019-01 - 2021-07)

Fast-Tracked Promotion to Programme Manager

• Excelled as top performing Research Scientist in analytical development (mAbs, proteins), mastering GMP documentation and complex instrumentation and methods
• Broke down silos in an open plan lab environment: became the go to knowledge bridge between Upstream, Downstream, and Analytical teams, improving data flow and reducing handoff errors
• Recognised for exceptional influence and systems thinking: offered a newly created Programme Manager role to retain talent after announcing intent to leave for career growth

BSc (Hons) - Biopharmaceutical Sciences - University of Sunderland