A Pharmaceutical / Biotechnology scientist with experience in the testing and review of QC Analytical procedures, coordinating Stability studies and managing stability testing and data trending, improving and validating analytical assays and procedures bywriting and executing validation protocols following ICH guidelines. Excels at driving business results through managing laboratory testing including related atypical and OOS investigations. Proficient in testing and reviewing analytical procedures for HPLC, GC, UV/VIS, IR, SDS-PAGE, AA, TOC, and other testing equipment.
01/2013 to Current
QA AssociateCutisPharma Inc － Wilmington, Ma
Ensure timely release of all bulk raw materials and finished product by auditing analytical documents
and review of other records relating to the disposition of raw materials and finished pharmaceuticals
and/or by comparison with approved specifications and regulatory requirements as per procedures.
Ensure that copies of all analytical or other reviews related to raw material and/or finished product
release, including stability data are properly maintained.
Assist in the management of QA inspections of contract manufacturers/re-packagers and contract
laboratories to ensure compliance with current cGMPs and to determine if process and products meet
established parameters and specifications.
Write and revise SOPs, technical protocols, and reports as needed.
01/2012 to 01/2013
QC Analyst IIMillennium Pharmaceuticals Inc － Cambridge, MA
Conducting the review of QC Analytical testing procedures from CROs and CMOs to support quality control operations.
Overseeing multiple analytical vendor test laboratories in both domestic and international locations.
Coordinating both batch release testing and stability programs.
Technical areas include in-process testing, release, and stability data review for both API and dose-form of drug products.
Capturing related deviations, OOS, and atypical results.
Resolving observations and corrections to GMP documentation.
01/2011 to 01/2012
QC Analytical Stability CoordinatorAMRI － Burlington, MA
Responsible for tracking testing time points, pulling samples for testing per the stability protocol, maintaining accountability of samples, and coordinating the reporting and review of data by QC.
Designed the stability protocols, upon request of the client, conforming to the storage requirements, storage configurations, test types, and frequency of testing with the client.
Performed QC Analytical testing procedures to support manufactured materials and various components following company SOPs, USP, EP and JP.
QC Analyst IVLANTHEUS MEDICAL IMAGING － Billerica, MA
Completed routine and non-routine QC Analytical Labs testing in accordance with SOPs, safety, and GMP guidelines to support quality release of finished products, raw materials, and various components.
Executed protocols for procedural and instrumentation validations.
Supported the resolution of performance testing issues for the analysis of drug substance and drug product.
01/2006 to 01/2010
QC Scientist IIIPFIZER / WYETH BIOPHARMA － Andover, MA
Collaborated cross-functionally with QC groups to identify areas of assay improvements.
Validated assays in cGMP laboratory using ICH guidelines.
Reviewed quality control documentation such as assays, assay logbooks, equipment maintenance and other related documentation.
Designed and carried out experiments to support validation of analytical methods increasing analytical efficiency.
Collaborated with key personnel to discuss and present a course of action to solve laboratory analytical issues.
Wrote and carried out protocols for analytical method validation, to improve analytical processes.
Performed technical presentations to managerial staff members identifying reasons for improving technical procedures for cost reduction purposes.
01/2002 to 01/2006
QC Scientist IIWYETH BIOPHARMA － Andover, MA
Fulfilled analytical assay testing of commercial raw materials, finished product, environmental monitoring samples and validation samples.
Identified atypical or out of specification test results and participated in investigations to resolve and correct problems.
Led cross-training of analysts on new and existing procedures, improving testing efficiency.
Managed control trending via the JMP program for various assays to track and record atypical observations that potentially slowed work progress.
As SME, mentored analysts by providing technical knowledge and support in resolving testing and equipment issues decreasing down time.
01/2001 to 01/2002
Quality Control Chemist IIMURO PHARMACEUTICALS － Tewksbury, MA
Responsible for training junior scientist and reviewing testing results.
Key participant in drug substance and drug product investigations.
Trained scientists in testing and review of stability samples, release of raw materials, active pharmaceutical ingredients and drug products in compliance with cGMP guidelines to ensure product release timelines.
Participated in review and validation of new techniques and methods of analytical testing to determine and solve any problems related to the procedure ensuring accurate results.
Prepared and analyzed pharmaceutical products using HPLC, GC, UV/VIS, IR, Karl Fisher, Malvern, and other testing equipment.
01/1990 to 01/2001
Research & Development ChemistBIOTEK INC － Woburn, MA
Developed and coordinated the production of proprietary drug product formulations on multiple projects.
Trained and supervised junior scientist on trouble shooting and method development.
Planned and developed preparation of polymers for encapsulation of drug products and performed analysis for sample drug content and residual solvents that ensured product timelines were met.
Designed and implemented use of formulations for dermal patch experiments using Membrane Diffusion Cell Apparatus.
Trained new personnel in use of HPLC and method development.
Education and Training
BS: ToxicologyNortheastern University － Boston, MAToxicology