LIZI J. MATHEW

** ******* ****

New Hyde Park, NY 11040

Email: adl6po@r.postjobfree.com

Phone: 516-***-**** (home)

516-***-**** (mobile)

SUMMARY

Manager/Supervisor/Scientist/Auditor /Regulatory Positions/R&D with strong management, Regulatory knowledge, training and trouble shooting skills. Strong analytical experience in Raw Materials, Finished products, Stability samples, in-process samples, R& D samples as per cGMP, USP, EP, BP, JP and in-house analysis. Expertise includes:

Analytical developments

Validations

Cleaning validations

Method transfer

Change Control

LIMS and Empower

Instruments Calibration

Deviation Studies

Out-of-Specification results investigation

QC and QA technical documentations.

Six-Sigma

Safety

Track-Wise

PROFESSIONAL EXPERIENCE

08/03/2020-Present Certified Laboratories, Melville, NY

Manager: Instrumentation

•Manages the Instrumentation Department staff and operations.

•Interacts with clients, vendors, and suppliers.

•Responsible for relevant ISO QA/QC activities and documentation.

•In a team environment, manages the Instrumentation staff to effectively ensure accurate, reliable, and timely results.

•Plan and schedule daily work assignments to comply with clients needs and produce the most effective utilization of employees, equipment, materials and other resources.

•Review daily transmittals and log sheets for accuracy and to appropriately schedule work

•Ensure all work is done to Certified Laboratories’ quality standards.

•Mange the continuous training of the Instrumentation staff and documentation of all training activities.

•Actively participate in the investigation of “Root cause “of Action Reports (CAR)

•Performance evaluations- conducts reviews, assigns goals and follows up on the goal process for 30, 90 and annual performances.

•Conducts regular 1:1 meeting with direct reports. Discuss work progress, any issues, acknowledgments, new projects and goals. Coach and mentor employees and take disciplinary actions if necessary.

•Working knowledge of the department technical SOPs.

12/12/2016-07/31/2020 Teva pharma, Elizabeth. NJ

Specialist : Technical Services

Preparation and review of method transfer Protocols and Reports.

Prepare Supplemental Method Validation and verification protocols and reports.

Develop/Validating Analytical methods and writing reports.

Perform or arrange for verification, crossover and supplemental validation testing.

Identify new technologies to improve lab efficiency.

Perform Method Transfer testing.

12/2015-10/2016 Teva pharma, Pomona. NY

Research Scientist (Kelly OCG)

Independently worked with projects in sterile injectable group.

worked with Electronic Note Books.

Supported Formulation groups for stability study and experimental samples.

Molecular Weight Determination by GPC.

Responsibility of Daily verification of Analytical Balances in Sterile group.

Trained newly hired Analytical Scientist.

03/ 2013-07/2015 Nature’s Bounty Inc, Bohemia, NY

Fellow Chemist

Actively developed, modified and validate HPLC, UPLC, IC, Dissolution methods.

Wrote, reviewed and verify laboratory notebooks, investigations, atypical data investigations, validation reports, protocols, update SOPS and change controls.

Conducted literature search and recommend better development method for soft gels, liquids and solid dosage.

Trained, mentor, recommend changes in and troubleshoot.

Conduct monthly audit for all USP standards, house standards.

12/2006-2/2013 Endo Pharmaceuticals Inc, Westbury, NY

Research Scientist

Independently worked on multiple projects to develop ANDA. Compiled all the data from the R&D Lab for the CMC submission. Worked as a project Leader for R&D projects

Developed and Validated HPLC,UPLC,IC and Dissolution Methods,

Conducted literature search and proposed better development method for soft gels and solid dosage.

Supported manufacturing group for timely API release.

Conducted SOP training and prepared monthly Safety and DEA audit.

Worked as a safety coordinator, and vault monitor for controlled substances and drugs.

Traveled to contract manufacturing operation (CMO) sites for technical support, problem solving, method transfer, and technology transfer and product qualification.

Participated in human resource activities to include interview and recruitment of new employees.

Worked as lead scientist for the ANDA submission projects.

02/2003 –08/2006 Pfizer Inc, Brooklyn, NY

Staff Analyst for QO Laboratory

Effectively managed daily QC laboratory activities, with complete training and troubleshooting of instrumentation, documentation of the analytical laboratory investigations and quality assurance reports.

Ensured compliance with 21 CFR, parts 210 and 211 as well as company procedures.

Supervised staff of seven Chemists.

Managed laboratories at optimal level for regulatory inspections by providing maximum safety and documentation control.

Achieved maximum output, quality and met all deadlines by effectively managing workflow.

Conducted laboratory investigations including Out-Of-Specifications.

Verified chemist documentations, gave final approval of data and verified data into the Lot Release System.

Reviewed and approved validation protocols and procedures such as Process Analytical Technology (PAT) and updated existing test procedures, including cleaning validation.

Worked as a Chemical Hygiene Officer.

Conducted safety and departmental procedures training every month, including the ISO 14001 certification.

Conducted Environmental Health and Safety (EH&S) monthly audit and incident investigations.

01/2002 –02 /2003 Bristol Myers Squibb Pharma, Garden City

Scientist, Quality Control and Stability

Managed multiple projects to support the manufacturing plant through timely release of products, conducted process validation and method transfer.

Planned and prepared for timely testing of stability samples and process completion.

Finished USP equivalency studies and monograph revision studies on time.

Utilized Multichrom and Empower expertise in HPLC and chromatographic data processing.

Verified Laboratory notebooks, reports and data analysis in LIMS.

12/2000 – 12/2001 Hoffmann-LaRoche., Nutley, NJ

Research Chemist, Pharmaceutical and Analytical R&D

Developed and validated analytical methods for new drug substance, impurities and drug product.

Conducted testing and provided analytical support to formulation development, drug product release and stability studies.

Performed data analysis in Turbochrom 6.1.1 system, input and verified data on LIMS.

01/1992 –12/ 2000 Eon Labs Manufacturing Inc. Laurelton, NY

Research Chemist II /R&D Department

Developed and validated cleaning validation, HPLC, GC and dissolution methods for final pharmaceutical products and stability.

Wrote and compiled data for analytical method and monograph documents for regulatory review.

Wrote, reviewed and verified laboratory notebooks, investigations, validation reports and protocols.

EDUCATION

MS, Organic Chemistry, R.D. University, India

Certificate: Six- Sigma green, Lean Belt from Villanova University

ADDITIONAL TRAINING

Completed Coursework:

“Methods Development, Validation Procedures” offered by Waters

10 hours Occupational Safety and Health administration (OSHA) training course for General industry.

Project Management, Civil Treatment for Managers and Trainer Qualification.

Participated in 21 CFR Part 11(Electronic records; Electronic Signatures) Workshop

Above and Beyond Reconization awards from Endo Pharmaceuticals Inc.

COMPUTER PROFICIENCY

Excel, Microsoft Word, outlook, PowerPoint Presentation, LIMS, Empower, HP/Agilent, Turbochrom 6.1.1, Multichrom, Windows XP, Electronic Note Book

ADDITIONAL SKILLS

HPLC, GC, FTIR, IC, UPLC, UPC, ICP-MS, LCMS, Dissolution (include on-line UV detection), KF and GPC

REFERENCE: Available upon request

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