Hplc, Lc-MS, Uplc, Gc, Gc-MS, Uv/Vis, Ir, Ft-Ir, Nmr Analytical Me

Bilkis Azad

Email: **********@*****.*** Tel: 718-***-****

An experienced senior level Scientist in the pharmaceutical industry with expertise in technical laboratory methodology, testing raw materials, stability samples, method transfer, in-process, process and packaging validation projects, complaints and finished dosages forms. A “right first time” attitude that embraces a quality mindset and culture. Good oral and written communication and leadership skills. A consummate, proactive team player. Proficient in technical writing, data trend analysis, federal and state regulations: FDA/ ICH/DEA/ EPA/USP/EP/BP/cGMP/GLP/GXP/OSHA /CAPA and Six-Sigma policies.

Professional Experiences

Teva Pharmaceuticals Inc. -Pomona, New York

Research Scientist (Jan’2016 - Current)

Physical Characterization and Separation of API's and Sterile drug products using Particle size analyzer (Light scattering), HPLC, UPLC, LC-MS, GC-MS.

Supports drug substance process development including characterization of In-process materials, and final API's.

Supports Analytical Method Development for Sterile Suspensions. Contribute to the development and implementation of new technology, specially improving ELN reporting.

Supports drug product Formulation and Process Development including characterization, identification of In-process materials and Finished product.

Performing analytical testing in supports of Stability Studies.

Develop methods for assays, impurities and dissolution for Immediate Release as well as extended release formulations to support ANDAs. Support Formulation Development.

Responsible for technical supports, including formulation and process development activities, characterization, confirmation, performance qualification, and continued process verification associated with marketed products.

Designs, manages and executes project task per established timeline. Accountable for achievement of project milestones.

Manages, troubleshoots, and make recommendations based on the results of the planned experimentation and investigations.

A multi task analyst effectively handles multiple projects and tasks of various complexities.

Strong validation engineering experience with Laboratory Information Management Systems (LIMS) and Integration with equipment’s (HPLC, GC, FTIR, Spectrophotometer, pH meter), Electronic Document Management System (EDMS).

Novartis Pharmaceutical Corporation – Suffern, New York

Senior Scientist: (Mar’2004 – Oct’2015)

Conducted a wide variety of routine and complex product analysis of tablets, capsules, ampoules, raw materials and active substances testing using applicable FDA, ICH, USP, EPA, DEA, CAPA, OSHA, cGMP, GLP, company policies and guidelines.

Performed testing for Assay, Impurities, Dissolution, Content Uniformity, Water Content using various equipment in a regulated laboratory environment.

Reviewed raw data for accuracy and validated the completed work of others in Empower and SAP-QM/LIMS.

Conducted and wrote laboratory investigation reports for OOS/OOE/OOT results. Closely worked with regulatory affairs, compliance issues and internal audit system. Knowledgeable of CFR Title 21 guidelines.

Reviewed Test Methods, departmental SOP’s and Protocols for accuracy. Reviewed standard inspection plans for analytical results according to Test Monograph version changes.

Well experienced in Chromatography data system, Lab instrument set ups and Troubleshooting.

Performed laboratory inspections, corrected audit observations made and took preventative actions to avoid further incidences.

Received, tested and evaluated customer complaint samples.

Interacted with various departments to get the dosage forms released to production for packaging and distribution. Communicated with cross functional groups to get products released for marketing.

Tested and validated process validation samples and special projects such as bulk hold time study, re-validation activities as assigned in support of product transfer from one site to another utilizing applicable analytical procedures.

Conducted analytical method development on assigned projects and performed method validation in compliance with cGMP requirements. Characterized products with NMR, IR, FTIR, UV/VIS.

Trained new associates in performing a variety of routine and non-routine testing of drug products. Assisted with the coordination of daily lab activities, maintenance of lab equipment and tracking of internal inventories.

Managed validation projects, designed validation quality plan(QP), reviewed protocols, SOP’s, performed analyses, processed data, audited data generated by others using LIMS/SAP-QM, reported results into LIMS for approval.

Performed Instruments Installation Qualifications (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for validation.

Bristol-Myers Squibb (BMS), Garden City, New York

Staff Scientist:(Mar’1994 - Jun’2003)

Performed routine and complex analytical testing on Raw Materials, Stability Samples, Finished Products, In-Process Materials, Validation and on Analytical Research Projects.

Participated in ILQ’s (Internal Laboratory Qualification) for new test methods and technology transfers to other sites. Created, implemented, and maintained internal SOPs based on regulatory standards.

LIMS super user and trainer for QC personnel. Responsible for LIMS data review and approval.

HPLC Software “Multichrom” super user and trainer.

Supported review and evaluate raw data for approval, performed by other analysts.

Provided analytical technology support for quality investigation and resolution. Provided sound scientific responses to resolve open investigation deviations.

Coordinated USP and EP testing with outside contract organizations to ensure cGMP compliances.

Managed reference standard materials and provided inventory for corporate and international usage.

Instrumentation Expertise

Skilled in operating and Troubleshooting of HPLC, LC-MS, uPLC, GC, GC-MS, UV/VIS, IR, FT-IR, NMR, Dissolution automated and manual, DSC, TGA, ICP, GFAA, KF Titrations, Polari meter, Particle size analyzers, Surface area analyzer, pH meter, DO meter.

Software Expertise:

MS Office(Word, Excel, PowerPoint) LIMS, MES, TEDI, Multichrom, Atlas, Millennium, Empower, SAP-QM, NuGenesis ELN, EDMS.

Education and Training

Master of Science in Chemistry, University of Dhaka, Bangladesh

Master of Science in Education, University of Dhaka, Bangladesh

Certificates

Pharmaceutical Technology Certification, St. John’s University, New York

Laboratory Analyst Certification Program, Seton Hall University (Novartis in-house training program)

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