ALPESH PATEL
Houston
Summary
An analytical Chemist with 16 years of pharmaceutical laboratory experience supporting analytical development, method validation, troubleshooting, stability programs, and technical transfers in regulated environments. Showcases strong background in HPLC/UPLC dissolution, FTIR, UV-Vis, Karl Fischer, and data-driven root cause analysis, with proven success leading method development & validation activities for drug substance and drug product programs. Experienced in partnering cross functionality with formulation, quality control & assurance, regulatory, manufacturing, and project management to support product development, commercialization, and lifecycle management. Brings deep expertise in analytical method robustness, data integrity, investigation support, and GMP documentation, with strong potential to contribute to biologics analytical development, QC, characterization, and CMC support.
Overview
1
1
Certification
17
17
years of professional experience
Work History
Analytical Chemist III
Capsugel - Lonza Group AG
05.2019 - Current
- Serve as a project leader within the Analytical Method Development and Validation group, acting in a client-facing role and ensuring analytical deliverables between external clients and internal technical teams.
- Cross-functionally collaborate with Formulation Scientists, QA, QC, Regulatory Affairs, Process Engineers, and Manufacturing to support development activities, technical transfers, scale-up, and commercialization readiness.
- Directly responsible for the development, optimization, qualification, and validation of analytical methods for drug substance and drug product formulations to support product development and commercialization.
- Design and execute analytical studies using HPLC, UPLC, dissolution, UV-Vis, FTIR, Karl Fischer, and related techniques to evaluate assay, related substances, product performance, and stability.
- Interpret complex analytical data to assess method suitability, degradation behavior, formulation interactions, and product quality trends.
- Lead and support investigations involving OOT, atypical results, product failures, and analytical deviations, using structured root cause analysis and corrective action planning.
- Author and review SOPs, test methods, validation protocols, reports, specifications, and technical development documentation in compliance with GMP and internal quality standards.
- Mentor and train junior chemists in analytical execution, data review, troubleshooting, and documentation best practices.
- Drive improvements in analytical efficiency, data quality, and laboratory workflows to enhance throughput and method robustness.
- Achievements
- Developed and validated 50+ analytical methods supporting assay, related substances, content uniformity, blend uniformity, dissolution, water content, disintegration, and water activity testing.
- Reduced analytical method runtime by 15%, improving laboratory throughput while maintaining method robustness and accuracy.
- Provided analytical support for 10+ successful technical transfers and validated development programs.
- Mentored 3 junior scientists/chemists, improving team readiness, training efficiency, and technical capability.
- Conducted rigorous testing and analysis to ensure compliance with regulatory standards.
- Mentored junior chemists, fostering skill development and knowledge sharing within the team.
- Implemented quality control measures, ensuring consistency in production output and reducing errors.
- Managed project timelines effectively, aligning R&D activities with organizational goals and objectives.
- Improved production efficiency by identifying opportunities for process optimization and implementing necessary changes.
- Maintained a safe laboratory environment by adhering to strict safety protocols and conducting regular inspections of equipment and facilities.
- Mentored junior chemists, providing guidance on experimental design, data interpretation, and professional development opportunities.
- Managed multiple projects simultaneously, meeting tight deadlines while maintaining high-quality work output.
Research & Development Chemist II
MAYNE PHARMA
01.2016 - 01.2019
- Developed, validated, and verified analytical methods to support R&D, quality, and manufacturing initiatives for generic pharmaceutical products and supporting Phase 3 ANDA submissions.
- Performed analytical testing of raw materials, in-process materials, finished products, informal stability samples, and specification development using chromatographic and wet chemistry techniques.
- Investigated analytical anomalies and generated technical summaries with recommendations for method, process, and sample preparation improvements.
- Participated in equipment qualification and system readiness activities during the Empower 2 to Empower 3 transition.
- Achievements
- Improved analytical precision and reproducibility through optimization of sample preparation techniques and instrument parameters.
- Supported successful completion of validation studies, technical projects, and development milestones.
- Contributed to laboratory readiness for internal, customer, and regulatory audits.
Analytical Chemist I & QC Chemist III
PATHEON - THERMO FISHER SCIENTIFIC/ DSM PHARMACEUTICALS
01.2010 - 01.2016
- Conducted routine and non-routine analytical testing to support product quality, development, and manufacturing operations.
- Supported technical transfer activities for drug product programs, including internal and external site transfers.
- Assisted with troubleshooting, deviation support, and lean 6S laboratory process improvement initiatives.
- Maintained laboratory instrumentation and contributed to compliant execution of testing in a regulated QC environment.
Education
Bachelor of Arts - Chemistry, Mathematics
East Carolina University
Greenville, NC01-2008
Skills
- Strong experience in analytical method development, validation, and troubleshooting applicable to complex pharmaceutical and biologics workflows
- Proven ability to generate and interpret high-quality analytical data in regulated GMP environments
- Experienced in stability assessment, degradation characterization, technical transfer, and cross-functional product support
- Well-positioned to contribute to biologics analytical development, QC testing, method lifecycle management, and CMC support
- Analytical method development
- Validation
- Regulated GMP environments
- Stability Assessments
- Degradation Characterizations
- Technical Transfers
- Cross-functional product support
- Biologics Analytical development
- QC Testing
- Method Lifecycle Management
- CMC Support
- Method development
- Chemical analysis
- Troubleshooting techniques
Certification
- Project Management within the Analytical Department (Client Interfacing)
- Lean Six Sigma - Yellow Belt
- Leadership Training
- GMP/GLP/cGMP Training
- OSHA Training - Lab Safety
Timeline
Analytical Chemist III
Capsugel - Lonza Group AG
05.2019 - Current
Research & Development Chemist II
MAYNE PHARMA
01.2016 - 01.2019
Analytical Chemist I & QC Chemist III
PATHEON - THERMO FISHER SCIENTIFIC/ DSM PHARMACEUTICALS
01.2010 - 01.2016
Bachelor of Arts - Chemistry, Mathematics
East Carolina University