ASSEGID OUMIE
Welwyn Garden City
Summary
Biopharmaceutical CMC expert with 20+ years' experience spanning CGT and Biologics programmes, leading the development and validation of cell-based, immunological, molecular, and biochemical assays. Working at the intersection of cell biology, analytical development, and quality systems, I enable seamless progression from early research through to IND/IMPD and BLA/MAA submissions. Proven track record delivering regulatory-compliant analytical CMC strategies, authoring complex dossiers, and leading cross-functional teams across the full development lifecycle. Skilled in QbD frameworks, technology transfer, and CRO/CDMO partnership management-leveraging a collaborative, hands-on approach to stakeholder engagement and consistent delivery. Currently seeking hands-on and/or leadership roles where deep CMC and analytical expertise can drive life-changing therapies to patients.
Overview
34
34
years of professional experience
Work History
Analytical Development and Quality Control Team lead
Hoxton Farms
11.2024 - 03.2026
- Lead analytical development and QC team to develop and validate fit-for-purpose assays for product characterisation and QC/release testing, and implement eQMS to ensure regulatory compliance and support the scalable manufacturing of cell cultivated Novel Food.
- Led the development, validation, and lifecycle management of biochemical, molecular, and ELISA-based methods for biomarker analysis in complex biological matrices, process optimisation, product characterisation, and QC release testing.
- Designed and implemented an analytical testing strategy, providing technical oversight and management of outsourced LC-UV, LC-MS, GC-FID, and GC-MS testing for product quality and impurity/residual analysis ensuring robust assay performance, reproducibility, data integrity, and GxP compliance.
- Provided strategic and technical regulatory CMC advice, conducted pre-submission consultations with regulatory agencies across three jurisdictions, authored and reviewed the Novel Food Technical Dossier, and contributed to the post-submission responses to regulatory feedback.
- Designed and implemented a regulatory-compliant, Notion database–based eQMS, integrating process change control (PCC), DRACAS-driven RCA and CAPA, and FMEA-based risk assessment, to evaluate and document the impact of process changes on product quality and safety.
Associate Director, CMC
Enara Bio
01.2023 - 07.2024
- Promoted to spearhead the development and execution of a CMC strategy to advance bispecific T-cell engagers (TCE; TCR×anti-CD3) from early research through to clinical manufacturing.
- Designed a phase-appropriate developability assessment pipeline underpinned by Quality by Design (QbD) principles and drove its implementation across the R&D-to-CMC continuum through cross-functional stakeholder engagement.
- Established and led a protein analytical laboratory, assembling a multidisciplinary team and implementing a comprehensive suite of chromatographic and biophysical methods for developability assessment, product characterisation, quality, safety, and QC/release testing.
- Led the CDMO and CRO qualification and selection processes in collaboration with external consultants, authoring URS, RFI, and RFP documentation, evaluating proposals and tenders, and driving data-driven decision-making to support cGMP manufacturing partnerships.
- Led a cross-functional team of seven scientists, spanning multiple seniority levels, to evaluate and select an optimal affinity anti-CD3 clone for deployment as the T-cell engager arm of a bispecific candidate.
Principal Scientist, CMC, Analytical Development Lead
Enara Bio
05.2021 - 12.2022
- Set up CMC labs, recruit and lead a team of scientists to develop and validate IND enabling analytical assays according to ICH guidelines, for a TCR-T cell based immunotherapeutic product.
- Established analytical and process development laboratories from concept to operation, overseeing layout design, equipment procurement, and staff recruitment on time and within budget, before leading the analytical team to generate IND-enabling datasets for a TCR-T cell immunotherapeutic programme.
- Led the development and validation of flow cytometry-based phenotyping, dPCR-based vector copy number (VCN), ELISA and cell-based cytotoxicity (potency) assays for TCR T cell characterisation and QC/release testing.
- Designed and executed analytical technology transfers to/from CDMOs and CROs applying First-Time-Right principles, and provided analytical technical oversight to ensure data equivalence and comparability during LVV and T cell manufacturing at CDMO sites, and RCL testing and LVV integration site analysis at CROs.
- Conducted pre-submission consultations with a regulatory agency and authored Quality/CMC sections of the CTD, supporting IND submission for a cell therapy immuno-oncology program.
Principal Scientist, BioPharm CMC (R&D and Genomics)
Covance/Labcorp
01.2020 - 05.2021
- Provide scientific leadership to a team of scientists in R&D and genomics operational areas, delivering customer solutions and ensuring flawless project execution under GLP/cGMP conditions.
- Led a team of 5 scientists to develop and validate qPCR/RT-qPCR assays for viral vector (AAV, LVV, HSV-vaccine) titre and in vivo PK studies (mouse and NHP models); enzymatic biomarker; flow cytometric phenotyping, ddPCR VCN, ELISA & cell-based potency assays for CAR-T cell QC/release testing under GLP/cGMP conditions.
- Provided strategic and technical regulatory CMC advice to internal team and clients and developed proposals in response to RFPs/RFQs and securing multiple IND/IMPD and BLA/MAA submission-enabling projects; ensured flawless project delivery through regular scientific discussions with customers, maintaining budget and schedule adherence.
- Designed and executed technology transfer of 5 analytical methods-including molecular (qPCR/RT-qPCR, ddPCR), ELISA, and cell-based potency assays to and from multiple customer sites, ensuring method equivalence in support of IND/IMPD and BLA/MAA regulatory submissions under GLP/cGMP conditions.
- Ensured high standards of data integrity, documentation, deviation management, OOS/OOT investigations, RCA, and CAPA implementation across multiple concurrent client-facing analytical programs in a regulated GLP/cGMP CRO environment.
Senior Assay Scientist
Avacta Therapeutics
10.2017 - 12.2019
- Develop cell-based, biochemical, and immunoassays to advance bispecific antibody therapeutics for immuno-oncology programs.
- Led a team of 2 scientists to develop ELISA and cell-based potency assays from the ground up to characterise bispecific proteins targeting immune checkpoint inhibitors (PD-L1, LAG-3) and T cell co-stimulatory agonists (CD28, GITR, 4-1BB).
- Engineered over 20 stable luciferase reporter gene cell lines-incorporating NFAT, AP-1, and NF-κB pathway-driven IL-2 expression construct-using lentiviral vectors (LVV) to support cell-based potency assay development for bispecific immune checkpoint inhibitor programs.
- Led an external collaborative R&D project with an mRNA therapeutics company to develop an affimer-based mRNA therapeutic, employing biolayer interferometry (BLI) to evaluate affimer-target binding affinity.
Senior Analytical Development Scientist
Cell and Gene Therapy Catapult
09.2015 - 06.2017
- Lead technical discussions with customers and recommend suitable analytical methods for their products, author proposals, design and execute tech transfers to and from customer sites, and lead assay development and validation.
- Provided technical consultancy to the BD team and customers, authored proposals and secured 3 R&D projects to develop and validate potency assays for cell therapy products in accordance with ICH guidelines; recruited and managed a team of scientists to deliver these projects.
- Led and project managed the development and validation of 3 novel potency assays for cGMP release of ATMPs, supporting a Phase III (EMA) clinical trial targeting critical limb ischemia and a Phase II (MHRA) trial targeting acute myeloid leukaemia (Patent pending).
- Led the development of Raman spectroscopy and Omics-based in-process controls for TCR-T cells in STRs and iPSC culture in automated bioreactors, supporting both immunotherapy and regenerative medicine programs.
- Designed, project-managed, and executed the tech transfer of 7 bioassays across 4 projects from customer sites for further development and validation, successfully substituting 3 assays with novel, purpose-built alternatives.
Staff Scientist
Affymetrix UK
04.2013 - 09.2015
- Lead the implementation of the microarray-based OncoScan CNV assay platform across TSB (Innovate UK)-funded industry–NHS collaboration laboratories for tumour genomic profiling and precision medicine in FFPE biopsies.
- Designed and executed the tech transfer protocol from the source laboratory in the USA to three NHS and CRO destination laboratories across the UK, and supervised day-to-day operations in a GCLP setting.
- Played pivotal role in further development of the OncoScan platform by collating novel CNVs and somatic mutations identified in previously untested patient samples and reporting to the R&D lab in the USA; generating new commercial opportunities for the company.
- Led orthogonal validation of the microarray method using the Illumina NGS sequencing platform across three sites and served as the subject matter expert for all OncoScan-related issues across Europe and the Middle East.
Senior Postdoctoral Research Associate
University College London (Wolfson Institute for Biomed. Research)
05.2006 - 07.2012
- Secured and managed funding, developed bioassays to evaluate T cell metabolism and the effect of drugs on cancer cells, led international collaboration projects, held home office module3 license for in vivo mouse studies, delivered courses and supervised graduate students, trained visiting scientists and junior staff.
Postdoctoral Researcher
Innsbruck Medical University, Austria
07.2004 - 04.2006
- Investigated mitochondrial metabolism in cardiac and skeletal muscle tissues, optimized assay protocols, delivered workshop courses, trained and supervised junior staff and students.
Doctoral Researcher
Medical Faculty, University of Würzburg, Germany
01.2004 - 06.2004
- Set up calorimetry lab and investigated metabolic adaptation of foetal tissue and cancer cells to hypoxia.
Lecturer
Department of Biology, Bahir Dar University, Ethiopia
11.1991 - 09.1999
- Delivered cell biology and biochemistry course to undergraduate and medical students.
Education
PhD - Biology
Free University of Berlin
Germany01-2003
MSc - Biology
Free University of Berlin-Addis Ababa University
Addis Ababa01-1996
BSc - Biology & Chemistry
Addis Ababa University
Ethiopia01-1991
Skills
- Isolation and culture of primary cells
- Genetic engineering of cells
- Handling of pathogenic bacteria
- Lentivirus production
- Multiparametric flow cytometry
- Confocal microscopy
- Fluorescence microscopy
- High content imaging
- Respirometry
- Enzyme biochemical assays
- Spectrophotometry
- Fluorometry
- Luminescence
- ELISA
- HTRF
- Luminex
- MSD
- Impedance spectroscopy
- Raman spectroscopy
- Metabolic flux analysis
- High dimensional data analysis
- SEC-HPLC
- RP-HPLC
- GC-FID
- GC-MS
- AC-SINS
- DSC/DSF
- DLS
- ICIEF
- CE-SDS
- SDS-PAGE
- SPR
- BLI
- Western blotting
- Immuno-precipitation
- Immuno-histochemistry
- Cloning
- Mutagenesis
- Plasmid propagation and purification
- Transfection
- MRNA extraction
- DNA extraction
- PCR
- QPCR
- RT-qPCR
- DPCR
- DNA sequencing
- Gene expression analysis
- Genomic analysis
- Bioanalysis of PK/PD biomarkers
- Chromatographic assays
- Molecular assays
- Enzymatic assays
- Immune-assays
- Regulatory dossier preparation
- Regulatory guidelines
- Strategic regulatory advice
- Technical regulatory advice
- Authoring regulatory documents
Languages and Hobbies
English
Italian
German
Amharic
Custom Section
- Isolation and culture of primary cells (PBMCs, T cells, monocytes/macrophages, stem cells/iPSC, cord blood- and bone marrow derived hematopoietic stem cells, fibroblasts, iPSC, HUVEC) from human, mouse and NHP biological material/biopsies.
- Genetic engineering of cells using transduction, transfection and electroporation, handling of pathogenic bacteria, lentivirus production, QC and transduction.
- Analysis of cells and cellular processes using multiparametric flow cytometry, confocal/fluorescence microscopy, high content imaging, respirometry, enzyme biochemical assays, spectrophotometry/fluorometry/luminescence, ELISA, HTRF, Luminex, MSD, impedance spectroscopy, Raman spectroscopy, and radio-labelled substrate based metabolic flux analysis, high dimensional data analysis.
- SEC-HPLC, RP-HPLC, GC-FID, GC-MS, AC-SINS, DSC/DSF, DLS, iCIEF, CE-SDS, SDS-PAGE, SPR, BLI, western blotting, immuno-precipitation, immuno-histochemistry, cloning, mutagenesis, plasmid propagation and purification, transfection (plasmid, shRNA/siRNA); mRNA and DNA extraction and analysis (PCR, qPCR, RT-qPCR, and dPCR), DNA sequencing (Sanger and NGS), gene expression and genomic analysis.
- Bioanalysis of PK/PD molecular and immunological biomarkers in complex biological matrices from human, mouse and NHP biological material using chromatographic-, molecular-, enzymatic- and immune-assays.
- Pre/post-submission discussion with Regulatory agencies (FDA, SFA-Singapore, FSA-UK), Regulatory dossier CTD module3 preparation for IND/BLA (FDA) and IMPD/MAA (EMA), Regulatory guidelines (FDA, ICH, EMA, FSA).
- Active participation in the drafting of FSA guidelines through the FSA Sandbox.
- Provide strategic and technical regulatory CMC advice to internal team and clients; author, review, and contribute to key regulatory documents supporting the development of ATMP, biologics and novel food.
Hobbies and Interests
- Sports
- Martial arts
- 4th Dan black belt in Shotokan karate
Timeline
Analytical Development and Quality Control Team lead
Hoxton Farms
11.2024 - 03.2026
Associate Director, CMC
Enara Bio
01.2023 - 07.2024
Principal Scientist, CMC, Analytical Development Lead
Enara Bio
05.2021 - 12.2022
Principal Scientist, BioPharm CMC (R&D and Genomics)
Covance/Labcorp
01.2020 - 05.2021
Senior Assay Scientist
Avacta Therapeutics
10.2017 - 12.2019
Senior Analytical Development Scientist
Cell and Gene Therapy Catapult
09.2015 - 06.2017
Staff Scientist
Affymetrix UK
04.2013 - 09.2015
Senior Postdoctoral Research Associate
University College London (Wolfson Institute for Biomed. Research)
05.2006 - 07.2012
Postdoctoral Researcher
Innsbruck Medical University, Austria
07.2004 - 04.2006
Doctoral Researcher
Medical Faculty, University of Würzburg, Germany
01.2004 - 06.2004
Lecturer
Department of Biology, Bahir Dar University, Ethiopia
11.1991 - 09.1999
PhD - Biology
Free University of Berlin
MSc - Biology
Free University of Berlin-Addis Ababa University
BSc - Biology & Chemistry
Addis Ababa University