Principal Scientist & R&D Lead, Nanotechnology

Experienced R&D and technical operations leader with 10+ years of experience in API manufacturing, process development, and GMP-aligned technology transfer, and extensive experience in nanotechnology in biotech

Led end-to-end R&D to GMP technology transfer and managed CDMO collaborations

Proven ability to lead complex technical programs across internal teams and external manufacturing partners, ensuring robust, compliant, and cost-effective supply

Strong background in MSAT-style activities, including process transfer, manufacturing troubleshooting, regulatory CMC support, and continuous improvement

Recognized for clear communication, structured problem solving, and hands-on leadership

Lead technology transfer from development to GMP manufacturing in nanotechnology-biotech company

Oversee CMOs/CDMOs, resolve issues, optimise and processes

Support GMP manufacturing: risk management, change control, CAPA, validation, documentation

Guide teams through leadership, mentoring, and capability building

Manage cross-functional projects and stakeholders

Content prep for CMC and regulatory documents (CTD Module 3, ASMF/DMF)

PAT Application, Data Analysis (MATLAB, MVDA, OriginPro) and QbD for process control

Data interpretation (PBM, CFD, gPROMS); Solid-state analytics & data (XRPD, DSC, TGA, IR, PSD)

Reporting, insight synthesis, presentations: LIMS, eQMS, documentation frameworks

Project & program delivery tools (digital lab systems)

Led optimisation of crystallisation-based nanoforming processes, reducing API production costs from approximately 30 to 4 €/g while maintaining strict quality requirements

Led end-to-end R&D to GMP technology transfer, ensuring effective handover of process knowledge to manufacturing environments

Supported the achievement of clinical and commercial EU cGMP licences through preparation and review of technical and regulatory documentation

Resolved process reproducibility challenges for multiple client APIs through mechanistic analysis and implementation of improved control strategies

Designed and commissioned advanced PAT systems to enhance real-time process understanding and manufacturing robustness

Applied multivariate data analysis to define design spaces and critical process parameters, supporting QbD-aligned control strategies

Provided pre-formulation and excipient compatibility input to support formulation strategy and product quality targets

Authored and reviewed CMC documentation, including CTD Module 3 sections and ASMF or DMF content

Mentored junior scientists and supported the development of internal technical capability

Led multiple large-scale transformation initiatives spanning tech transfer, operating model refinement, and end-to-end process improvement for a DKK 1.5B manufacturing site build-out

Led scale-up activities from laboratory through pilot and large-scale manufacture, contributing to reactor design, process definition, and validation strategy

Managed CDMO collaborations, strengthening external partnership strategies and expanding organisational capability

Managed cross-functional project execution to meet timelines and quality objectives, leading a team of scientists, technicians, and external research collaborations

Oversaw operation of the MSAT chemistry laboratory, including EHS training, equipment oversight, and resource planning

Led process improvement and optimisation projects for late-stage and commercial APIs, enhancing operational efficiency and contributing £1.2M in cost savings over 2.5 years

Developed SOPs, workflows, and performance metrics to support operational excellence and drive continuous improvement for capital investment decisions

Managed cross-functional interactions with manufacturing, quality, and supply chain stakeholders, aligning priorities and resolving delivery blockers

Supported regulatory and technical documentation development, contributing to organisational readiness and strategic risk management