Dina Elhemeidi

Innovative and detail-oriented Senior Pharmaceutical Quality Professional and Analytical Chemist with over 10 years of progressive experience spanning analytical chemistry, GMP compliance, analytical data review, and data integrity within pharmaceutical R&D, formulation development, and quality control environments. Proven expertise in reviewing thousands of complex GMP analytical data packages, identifying compliance risks, interpreting/correcting HPLC datasets, and executing robust OOS/CAPA risk-mitigation strategies. Adept at leading cross-functional collaborations across QA, manufacturing, and research disciplines while driving technical recruitment, interviewing candidates, and mentoring teams to maintain strict regulatory compliance.

Senior Analytical Data Checker at Almac Group (2021-01 – Present)

• Lead the compliance and rigorous auditing of thousands of complex GMP and ICH-compliant analytical data packages, systematically reviewing 2–4 high-complexity records daily to ensure complete structural protocol adherence.
• Validate analytical data extracted from method development protocols, troubleshooting, interpreting, and correcting intricate HPLC data trajectories via Empower 3.
• Conceptualized, structured, and implemented comprehensive internal training frameworks, successfully onboarding, training, and mentoring approximately 15 technical data reviewers to operational autonomy.
• Actively involved in the department's technical recruitment and interview processes; partner with HR to evaluate technical skill sets, conduct competency-based interviews, and onboard incoming analytical professionals.
• Utilize systems such as TrackWise and Empower 3 to flag deviations, build out new laboratory reporting SOPs, drive CAPA actions, and contribute to regulatory inspection and audit preparation.
• Partner closely with QA, R&D, and manufacturing teams to address and resolve multi-layered data discrepancies efficiently.

Analytical Chemist at Almac Group (2019-01 – 2021-12)

• Conducted highly accurate HPLC and dissolution analyses on raw materials, manufacturing intermediates, and finished commercial drug products.
• Managed multi-sequence analytical data tracking utilizing Empower 3, guaranteeing uncompromised audit trail traceability and cGMP compliance.
• Spearheaded Out-of-Specification (OOS) laboratory investigations, performing detailed root cause analysis and implementing defensive CAPA parameters.
• Maintained strict daily cGMP alignment, proactively driving laboratory inspection readiness frameworks and ongoing quality improvements.
• Coached and mentored junior laboratory staff on analytical instrument operation, data workflows, and complex method troubleshooting.

Formulation Analytical Chemist at Aesica Pharmaceuticals (2015-01 – 2015-12)

• Supported the scalable development of novel drug formulations by executing precise quality control testing on critical raw materials, release samples, and stability intervals.
• Executed quantitative assays, advanced dissolution profiling, and Karl Fischer moisture analyses to assess formulation stability and guarantee final product quality.
• Assisted in the critical technical scale-up of target formulations from small-scale laboratory environments to pilot batches, maintaining structural consistency and cGMP parameters.
• Ensured highly accurate and rapid data reporting cycles, directly accelerating successful regulatory dossiers and product approval pipelines.

Analytical Scientist at 3M (2009-01 – 2013-12)

• Performed specialized analytical safety and quality metrics on oral inhaler pipelines, executing dose uniformity, precise API assays, and laser diffraction particle size analysis.
• Deployed HPLC and UV-Vis platforms for accurate active pharmaceutical ingredient (API) quantification and rigorous method validation structures.
• Designed and executed strategic stability studies over extended intervals to mathematically support product shelf-life and storage claims.
• Facilitated the clean transfer of analytical methods from R&D spaces over to commercial manufacturing lines in strict adherence to cGMP and ICH documentation guidelines.

MSc in Analytical Chemistry – Loughborough University (2008)

BSc in Chemistry – University of Leicester (2007)