Complex deviations.
Clear decisions.

Biologics CDMO; J.POD monoclonal antibody drug substance manufacturing facility.

• Managed major and minor deviations for a multi-product drug substance facility, applying structured triage and investigation workflows to support manufacturing continuity and timely batch disposition.
• Chaired CAPA reviews with Manufacturing, Quality, MSAT and Engineering to address a high-volume deviation backlog, contributing to a 15% reduction.
• Investigated non-conformances across bioreactor processing, viral inactivation, UF/DF and Protein A chromatography, using systematic RCA to develop CAPAs that reduced recurring processing issues.
• Served as a manufacturing compliance subject matter expert, documenting product impact against safety, identity, strength, purity and quality (SISPQ) and preparing inspection defence summaries; authored inspection-ready deviation reports were never recalled or reopened for additional information.
• Worked with cross-functional leaders on non-routine J.POD manufacturing challenges, developing technical solutions that supported operational throughput.

Biomanufacturing CDMO supporting clinical and commercial production.

• Led non-critical and major quality-event investigations across clinical and commercial operations, applying Fishbone and 5 Whys analysis and coordinating stakeholders to achieve 100% on-time closure of assigned investigations.
• Prepared investigation reports covering product impact, root cause, CAPA and follow-up measures, providing inspection-ready evidence for FDA and client audits and supporting batch release decisions.
• Built investigation plans with QA, Manufacturing, Technical Operations and subject matter experts under tight production schedules, improving investigation efficiency and implementing CAPAs to address recurrence.
• Reviewed non-conformance, OOS and OOT trends across operational teams to focus investigation priorities and improve the accuracy of root cause assessments.

mRNA vaccines and therapeutics; clinical and commercial manufacturing.

• Led investigations primarily supporting downstream manufacturing, applying Fishbone, 6M and 5 Whys analysis to identify causes, implement CAPAs and verify effectiveness, supporting deviation resolution and operational efficiency.
• Addressed major QC and laboratory deviations by streamlining root cause assessments and CAPA implementation, contributing to a 25% improvement in on-time deviation closure and a sustained reduction in backlog.
• Led cross-functional resolution of manufacturing issues, coordinating change controls and technology transfer support to improve efficiency and Right First Time outcomes.
• Worked with QA, Manufacturing and Supply Chain on new product introductions across clinical, process performance qualification (PPQ) and commercial stages, supporting operational readiness and regulatory inspections.
• Reviewed open deviations and wrote inspection defence narratives aligned with CAPA lifecycle status, giving audit teams clear summaries of investigation progress and corrective actions.

CDMO providing sterile biologics drug product and fill-finish manufacturing.

• Completed deviation investigations, product impact and risk assessments using Fishbone and 5 Whys, translating root cause findings into CAPAs to address manufacturing quality events.
• Provided quality oversight of area-specific change controls, deviations and CAPAs, reviewing investigation evidence to support consistent quality decisions.
• Executed CAPA effectiveness checks against intended outcomes, documenting whether corrective actions adequately addressed the quality events.
• Trended non-conformances, OOS and OOT failures and developed targeted investigation plans, helping manufacturing teams identify causes and reduce process deviations.
• Led weekly cross-functional deviation and CAPA meetings to resolve outstanding investigations and effectiveness checks, reducing the deviation backlog by over 35%.

Sterile injectables manufacturing site.

• Trained manufacturing personnel in aseptic practices and reinforced correct technique in filling areas, supporting consistent execution of sterile manufacturing procedures.
• Conducted investigations with plant personnel for Technical Sterility Services and authored formal reports, documenting evidence needed to assess process and procedural non-conformances.
• Performed impact and risk assessments and supported root cause determination for aseptic manufacturing events, enabling the selection and implementation of appropriate CAPAs.
• Assisted in writing installation, operational and performance qualification (IQ/OQ/PQ) documentation for aseptic process validation, supporting the preparation of qualification records.

CDMO supporting client product transfer and sterile drug product manufacture.

• Supported transfer of client products into manufacturing by coordinating with technical representatives, conducting facility walkthroughs and checking operational readiness for formulation and fill-finish activities.
• Provided floor support across formulation, filling, packaging and inspection, troubleshooting process issues and documenting deviations to support manufacturing execution.
• Trained operators and worked with client technical representatives and Person in Plant observers on packaging and inspection matters, providing technical guidance for production activities.
• Monitored process performance data across production batches and presented quarterly technical reports to cross-functional stakeholders, informing continuous improvement plans that reduced recurring process issues by 28%.

Manufacturing technology and process support for client products.

• Evaluated bench and pilot-scale data with Process Development and client teams, selecting equipment and single-use components and defining in-process testing strategies to support large-scale manufacture.
• Authored or coordinated process flow diagrams, process descriptions, batch records, buffer and media formulation records, sampling plans and bills of materials, translating process requirements into GMP manufacturing documentation.
• Analysed manufacturing process trends, troubleshot technical issues and prepared post-run campaign reports, providing documented findings and proposed actions for process improvement.
• Provided technical guidance to the validation group for process validation and continued process verification, supporting assessment of manufacturing process performance.
• Worked with Process Development, Process Engineering and technology vendors to assess new manufacturing technology, supporting its implementation at production scale.
• Trained operators and mentored junior scientists, engineers, co-op students and interns, supporting the transfer of process knowledge within manufacturing teams.

University consortium researching lyophilisation and freeze-drying technology.

• Led a chemical decomposition study using residual gas analysis and interpreted lyophilisation data in Python, informing the design and optimisation of freeze-drying cycles.
• Designed and fabricated research prototypes, devices and systems, refining equipment designs to meet intended performance requirements.
• Planned and conducted experiments using LyoStar 3, Millrock REVO and Micro freeze dryers, a residual gas analyser and freeze-drying microscopy, producing technical reports and documented research findings.
• Trained incoming researchers in cycle development and equipment operation, supporting their use of freeze-drying systems for research work.

Chemical and fertiliser manufacturing.

• Developed an alternative model flow chart for a sulphonated naphthalene formaldehyde plant, documenting a revised representation of the manufacturing process.
• Monitored manufacturing processes in urea, ammonia and diammonium phosphate plants during an engineering internship, developing practical understanding of industrial chemical production.

Research project on treatment of dairy and textile industry effluents.

• Synthesised chitosan with activated carbon and zero-valent iron nanoparticles for laboratory effluent-treatment research, providing materials for the project's treatment studies.
• Studied submerged membrane bioreactors using Python DataFrames and matplotlib for data analysis, reporting a 72% reduction in effluent in the treatment study.
• Developed a mathematical model of the diffusion mechanism and performed a cost-benefit analysis of submerged membrane bioreactors, supporting evaluation of the treatment approach.

Protective coatings testing and quality control.

• Led a testing and verification team in protective coatings quality control, achieving throughput of 550 samples per day.
• Resolved technical issues with a Brookfield viscometer during quality control testing, saving 20 company hours per week.