Sonia Badiani

Technical Project Manager with 15+ years' experience delivering complex product development programmes within engineering and manufacturing environments. Proven track record managing end-to-end product lifecycles from concept through to commercialisation, working with cross-functional technical teams across development, manufacturing, and quality. Strong expertise in stakeholder management, supplier engagement, cost and risk control, and delivering multiple concurrent projects on time and within budget.

Experienced in translating complex technical requirements into structured delivery plans and ensuring alignment between technical teams and business objectives.

Project Manager for Development and Commercialisation - Universal Medicines Limited - Surrey

(2025-07 - 2026-01)

• Led end-to-end delivery of complex programmes, translating stakeholder requirements into structured plans and deliverables
• Prioritised workstreams and managed evolving requirements to ensure delivery aligned with business and user needs
• Acted as regulatory interface, supporting submissions and Health Authority interactions (MHRA/EMA)
• Developed regulatory strategies, timelines, and lifecycle plans aligned with global objectives
• Led cross-functional teams, stakeholders, ensuring alignment, accountability, and on-time delivery of project milestones
• Established project governance structures, tracked risks and issues, and provided regular reporting to senior stakeholders to ensure delivery against milestones
• Supported post-approval lifecycle activities including variations and process improvements

Project Manager / Industrial Affairs Officer, Product Development and Medical Services - SERB / Veriton Pharmaceuticals - Surrey

(2024-07 - 2025-06)

• Acted as primary regulatory for product portfolio, managing submissions and lifecycle activities
• Led preparation of CTD dossiers, variations, and regulatory filings, achieving accelerated MHRA approval
• Managed Health Authority communications, supporting regulatory strategy and compliance
• Managed complex technology transfer projects across multiple CMOs, ensuring delivery to timeline, budget, and quality requirements
• Managed a portfolio of 7 projects with budgets up to ~ £1M, delivering all milestones on time and within budget
• Led cross-functional teams, ensuring delivery against regulatory and commercial timelines
• Drove CAPA, deviation management, and regulatory-compliant investigations
• Supported artwork and labelling compliance aligned with regulatory standards

Senior Development Scientist - GlaxoSmithKline - Hertfordshire

(2023-02 - 2024-07)

• Supported regulatory compliance and product registration activities across global markets
• Led investigations, CAPA, and deviation management aligned with GxP requirements
• Contributed to successful product launches and validation strategies
• Authored regulatory and quality documentation (SOPs, protocols, validation reports)

Senior Scientist - GlaxoSmithKline - Hertfordshire

(2022-07 - 2023-02)

• Led protein expression, purification, and analytical characterisation to support biopharmaceutical development
• Expressed and purified recombinant proteins using molecular biology and bioprocessing techniques
• Ensured compliance with GxP and conducted risk assessments for product safety
• Performed analytical characterisation including HPLC, mass spectrometry, and SDS-PAGE
• Mentored junior team members and supported project documentation

Senior Scientist - UCB CellTech Biopharma - Berkshire

(2022-01 - 2022-07)

• Directed process optimisation for protein therapeutics and supported technology transfer activities
• Applied QbD and DoE methodologies to improve process performance and scalability

Senior Scientist, MSAT Pilot Team (Upstream process) - Lonza - Berkshire

(2020-10 - 2021-12)

• Supported GMP process transfer and scale-up for biopharmaceutical manufacturing
• Coordinated batch execution, validation activities, and deviation management
• Applied QbD and DoE methodologies to improve process performance and scalability

Scientific Officer - Cancer Research UK - Hertfordshire

(2017-04 - 2020-10)

• Developed and manufactured biological anticancer therapies for early-phase clinical trials in a GMP environment
• Led cell therapy production, documentation, and process optimisation

R & D Associate - MedImmune (AstraZeneca) - Cambridge

(2010 - 2017)

QC / Microbiology Analyst - Generics UK Ltd - Hertfordshire

(2003 - 2005)

Chemistry QA, R & D, QC Analyst / Respiratory Laboratory - GlaxoSmithKline - Ware

(2002 - 2003)

Trained Pharmacy/Healthcare Assistant - Boots the Chemist - London

(1995 - 2003)

Trainee IT Manager - English Abrasives & Chemicals - London

(2001 - 2002)

Chemistry Analyst - Community Foods Ltd - London

(2001 - 2001)

Research Analyst for Flavours and Emulsions - Bush Boake Allen BBA - London

(1999 - 2000)

BSc (Hons) - Chemistry - University of Hertfordshire

PgCert - Personal Skills & Business Management - Middlesex University