Development Quality Control

SUMMARY

Analytical Chemist with extensive knowledge of and experience with drug development and working in accordance with GLP and cGMP, safety and regulatory requirements. Specific experience in method development and validation of chromatographic separations. Proficient in identification and characterization of organic compounds through analytical techniques such as HPLC, LC/MS, NMR and UV-Vis. Proven excellence in collaborative and independent performance. Strong organizational skills with the ability to manage multiple projects simultaneously. Great ability to function well within multi-disciplinary, high intensity environment.

EXPERTISE AND SKILLS

Separation Science

● HPLC ● UPLC ● LC/MS ● GC

Pharmaceutical Characterization

• Method Development • Drug Substance Purity • Stability

• Method Validation • Chiral Purity • Solubility

• Quantitative NMR • Residual Solvent Analysis • Dissolution

• cGMPs • ICH/EMEA Guidelines

• Drug Substance and Formulated Product Release

Biopharmaceutics Characterization

• GI Solubility • Dissolution

PROFESSIONAL EXPERIENCE

Agilent Technologies, Wilmington, DE Apr 2011- Present

Scientist, Research & Development

Support applications, research & development groups during all phases of development of HPLC columns by developing , troubleshooting and optimizing HPLC methods and conditions.

Repair and troubleshoot Agilent HPLC and UHPLC.

Astra Zeneca, Wilmington, DE 2007 – Mar 2011

Scientist, Early Development

Delivery of analytical pharmaceutics expertise in a multidisciplinary group to support discovery and early development projects. Conduct experimental work to evaluate stability of drug substance and drug product from discovery to phase I. Provide analytical support for development of formulations for pre-clinical and clinical use. Work in accordance with GLP/cGMP guidance.

• Developed and validated analytical methods for release and stability testing of drug substance and drug product using fit for purpose approach

• Wrote stability protocols, set up and carried out stability studies to support preclinical and phase I studies

• Prepared documentation for pre-clinical toxicology studies and phase I studies

• Contributed to writing CMC section of IND submission

• Independently planned, executed and interpreted work on complex analytical projects including stability studies

• Coordinated with project team members to ensure goals are met and projects completed in timely manner

• Successfully completed projects with positive feedback from team members and manager

Introduced Visual Planning to Early Development Group

• Designed and implemented visual aids to assist department with effective utilization of resources,

• allocation of tasks, visualization of all TA and non-TA projects related work, prioritizing deliverables

• and improving overall communication to meet the challenges of an increasing portfolio

• Delegated responsibilities to visual planning team members

• Assumed team leadership role to discuss resources, work load and project updates at daily meetings

Immune Response Corp, King of Prussia, PA May 2006 – Dec 2006

Senior Quality Control Analyst

Perform analytical testing to support manufacturing of clinical supplies by analyzing process validation,

in process samples and final product. Test APIs and drug products for stability. Perform Environmental Monitoring and Water Testing ( LAL, TOC & Conductivity).

• Reviewed lab notebooks, QC data sheets and SOPs

• Trained and transferred acquired technical skills to new employees.

Sanofi-Aventis Pharmaceuticals, Malvern, PA 2000 – 2005

Scientist, Analytical Development

Conduct analytical method development and validation for assay and impurity profile for drug substance and drug products. Perform stability testing on commercial and non-commercial dermatological products (creams, lotions & ointments), while ensuring compliance with cGMP/GLPs. Provide analytical support for development of formulations for pre-clinical and clinical use. Calibrate lab instruments.

• Developed and validated analytical methods for drug substance and drug products

• Authored reports, methods, SOPs, and instrument operating guides.

• Worked as backup for stability & Clinical Supplies coordinator, coordinated off-site testing for microbial quality (AET & MLT), generated labels according to SOP and the shipped samples to various study locations.

• Trained junior staff

Sanofi-Aventis Pharmaceuticals, Collegeville, PA 1997 – 1999

Analytical Chemist, Pharmaceutical Quality Analysis

Analyze pharmaceutical inhalation products: Unit spray content, dose delivery through sprayhead, particle size distribution analysis using HPLC. Perform dissolution I & II testing using UV Spectrometer and HPLC and water determination by Karl Fischer Titration. Perform LIMS data entry and review. Calibrate lab instruments, perform routine maintenance and troubleshooting.

• Reviewed lab notebooks, and SOPs

• Trained and transferred acquired technical skills to new employees.

Cephalon Inc., West Chester, PA 1996 – 1997

Research Associate, Drug Safety

Perform sample inventory, notebooks and data review, and protein binding assay using RIA

EDUCATION

Bachelor of Science in Clinical Chemistry, West Chester University, West Chester, PA

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