SUMMARY

Eighteen (**) years of extensive experience in Pharmaceutical, Medical Device industry, and biological testing company.

Detailed expertise in cGMP and CGLP focusing on Clinical and Commercial production of finished drug products and devices.

Proficiency with LIMS and Statistical Software (JMP) for data.

Competent user of Livelink and SAS, in addition to DCAS (Data capture analysis system) and JMP (Statistical software).

Excellent problem solver; team and discussion facilitator; and analytical representative.

LABORATORY SKILLS

Protein Characterization Techniques:

SDS-PAGE

HPLC

Western Blot

ELISA-based assays

Microbiology & Cell Biology Techniques:

Basic Cell Culture techniques and Media Preparation

Tissue culture (Microbial Culture) and Sterile and Aseptic Technique

Protein Engineering Techniques:

RIC PCR

Minipreps

Protein expression in E. coli.

Chemical/Analytical Techniques:

Chromatography

Spectrophotometry

Electrophoresis

Reverse Phase HPLC

Spec scan (Gravimetric and volumetric)

Osmolality

Molecular Biology Techniques:

Isolation of DNA

Transformation of E. coli with pUC DNA & size determination of DNA fragments

Purification and Identification of plasmid DNA

Restriction Endonuclease Analysis of DNA and other basic methods involved in manipulation of DNA and RNA

DNA Sequencing using ABI 310 Genetic Analyzer; PCR; mtDNA sequence analysis.

Restriction mapping of lambda chromosomes and construction of genomic Library of lambda DNA

Transformation of E. coli with lambda library

Colony hybridization of lambda library

Primer design, Optimization of PCR for 12S rRNA primers

DNA extraction from insect flight muscle tissue, Extraction, and analysis of RNA

Effects of DNA Methylation on Restriction, Solution/Dilution, and enzyme catalysis activity of Peroxidase

EMPLOYMENT:

TSS – Technical Safety Services: Berkeley, CA

Quality Control Analyst III/IT Help Desk Support:

(Apr 2022- Mar 2024)

Ad Hoc IT Help Desk: Helped with IT desk support work, which entailed resolving transcription and certificate correction/updating work. Thorough quality check of certificates and general certificate updates and correction requests that came through different departments. These IT tickets were quite time sensitive and with a set deadline which was monitored through a system and reported back to the assigned analysts.

Project Coordination: resolving specific project related queries, providing support and clarification to the TW Dept. Collaborating with different departments including operations and field technicians to resolve discrepancies in data and verifying client specific criteria/SOPs. Assisting technical writing (TW) department with fulfilling client requests and transcribing data upon field technician requests.

QC check of COA (TSS approved EM media for field services): We checked specified vendors on the products specification provided by the QA department. Examined product specification for compliance with internally controlled vendors in accordance with QA work instructions. Followed SOP to make sure only compliant media was used and coordinated with QA to resolve issues related to non-compliant media.

Lab results: Verifying lab results for their accuracy against recorded field data and defined parameters in line with USP <797>, USP <1116>, & client specifications. Making applicable corrections and coordinating with Microlabs team to re-issue the corrected lab results to the clients.

Media vendors: Working with media vendors to get a certificate of analysis (CoA) document and uploading media certificates for internal tracking.

Other responsibilities: Knowledge based development of required validation product documentation including protocols, summary reports, data quality analysis of products and services rendered. Work alongside subject matter experts to provide clear and concise data for reporting purposes. Work in coordination with quality assurance team to resolve NCPs in ISO 9001 certified environment. Analyzing data collected in the field for with compliance internal and external standardization protocols such as USP <797>, USP <800>, ISO 14644:1999 & 2015, and ISO 8573.

TSS – Technical Safety Services: Berkeley, CA

Data Quality Analyst:

(Nov 2019- Apr 2022)

Performing thorough quality check of the data against USP <797> and ISO standards along with other normative documents. Performing quality control checks of reports, coordinating projects and processes for a national biological testing company. Duties included project management, data formatting, analysis, quality checking, and maintaining client accounts. Strong attention to details which required expert knowledge of contamination, cleanrooms, pharmaceutical procedures, and pharmacy’s standards to ensure safety of client operations. This position utilized Microsoft Visio, Excel, Adobe Acrobat, and in-house report generation software.

Technical Writer/Editor:

(Aug 2012- Oct 2019)

Independently writing technical scientific report for biotech, medical device, and bio-pharmaceutical industry and USP <797> Pharmacies.

Making sure the accuracy of data, interpreting the data in terms of national standards (ISO and 797) and SOPs, formatting the data for informative presentation in formal reports, writing textual explanation of the data, and compiling and proofreading the formal reports.

Data formatting, analysis, quality checking, and maintaining client accounts and projects coordination and data management. Strong attention to detail that required expert knowledge of contamination, cleanrooms, pharmaceutical procedures to ensure safety of client operations. This position utilized Microsoft Visio, Excel, Adobe Acrobat, and in-house report generation software.

Writing CER (Controlled Environmental Monitoring) EM (Environment Monitoring) and CGS (Compressed Gas System) Reports. These reports clearly explain the testing procedure, standards, criteria, and results of the TSS field product. Additionally, reports included Auto Cad or Visio Diagrams representing the relative sampling locations (including Terminal Air Filter, Non-viable, and CSG locations) copies of all field notes and data sheets generated on-site during the tour, as well as copies of the most recent calibration certificates for the instrument used during the tour. These documents are designed and executed to withstand harsh audit scrutiny.

Assisted IT Department in a project for software development to generate report templates automatically in a more efficient manner. Ordering media, generating tracker sheets for service order packets. Sending out environmental monitoring (USP 1116 & USP 797) lab results, uploading and archiving media certificates. Reviewing, tracking, scanning, uploading, archiving, and maintaining inventory list of media. Closing out purchase order and fulfilling client’s requests about species identification test results and other inquiries related to reports and labs.

Encoll Corporation: Fremont, CA

Marketing and Customer Service Representative

(Jan - June 2012)

Worked on advertising and marketing company's wound care products.

Also, assisted in administrative work. Updated SOPs and made required corrections and compliance reviewed documents. Reviewed manuals and corrected formatting of existing documents. Worked on a project to create to slideshow about market value analysis for similar products.

Researched wound care market's different aspects such as number of patients per year, health care system expenditure to treat patients, the management and treatment of chronic and complex wounds estimated expenses per year. On an average, the cost analysis to close a chronic wound.

The total worth of U.S. market for advanced wound care technologies, which encompassed different wound care market segments, different wound care products in the market and how our product was different and more cost effective.

Investigated wound care market for comparative analysis of wound care products available including the size of market and need of products. Presentation work was done as a part of fund-raising process for the company.

Genentech / Roche Pharmaceuticals: South San Francisco, CA

QC Data Analyst

(Mar – Dec. 2010) - Contract position

Support MMTech regulatory inspections by quickly providing documents & data.

Key contributor to method monitoring process.

oIndependently assessed acceptance criteria for a protocol.

oWorked with QC network to collect data for all commercial QC methods including international sites method.

oData processing and data management of different methods used for analytical testing.

oReview data for accuracy, correctness, and completeness.

oWork with sites to get data corrected as required.

oOrganize, track, and archive method monitoring data from various sites.

oUpdated data request templates & memos for all the products.

oManage global approval-routing of protocols and reports.

Manage the method transfer document tracking Investigated.

oVerified and reconciled electronic and hardcopy versions of each method transfer document, historical and current, for all marketed products. Inventory, organize, scan, and publish PDFs of MMTech method transfer archives for all commercial Genentech products.

oWork with subject matter experts and site contacts to resolve transfer document gaps.

Support MMTech method life cycle management activities.

oCompliance review work of method transfer to external site.

oReview commercial QC method monitoring protocols, reports, and project plans for technical accuracy and GMP compliance.

oMining data from disparate formats (physical and electronic) and consolidating into a traceable, compliance reviewed output.

Support other MMTech activities with compliance review of a new product stability study, and a reference material qualification project.

Rapidly learned and successfully utilized LIMS and FileNet for data mining.

Auditing work: Compliance review of acceptance criteria for transfer protocols, identifying any discrepancies, and helping in the process of corrections of pre-existing documents.

Cholestech / Inverness Biomed: Hayward, CA/ San Diego, CA

Lab Technician / Process Engineer Chemist: (02/2009 - 06/2009) - Contract position

Used Laboratory system i.e., DCAS (Data capture analysis system) to perform testing using Whole blood, Finger sticks and serum samples. Klemm testing (wicking glass qualification), Blood processing by use of centrifuge and hemotocrit reader.

Performed hands-on lab and process tasks including processes and lab area set up. Supported in getting CRMLN (Cholesterol Reference Method Laboratory Network) certification for TC and HDL. Familiarized with DCN process.

All testing was performed using LDX devices including Lipid profile plus Glucose, ALT/AST, and Hs-CRP cassette. Utilized JMP Statistical software for data analysis. LDX optics check for daily maintenance

Material evaluation and preparation; documentation and assessment; and cassette performance testing.

LDX calibration including, temperature, dry, and wet calibration. Final functional testing (FFT) of LDX devices using FFT equipment. Paperwork to complete LDX DHR (Device history records), document calibration, and test results.

Genentech: South San Francisco, CA

(2007- 2008) – Contract positions

Research Assistant (07/2008 – 12/2008) - Protein Engineering

Used restriction independent cloning to generate baculovirus & E. coli expression constructs for various small molecule drug targets. CRISPR baculovirus – protein expression and purification

Laboratory techniques: recombinant DNA techniques including gel electrophoresis of DNA, PCR, ligations, minipreps, and transformations.

Transformed desired plasmid DNA into different E. coli strains and assisted in testing the protein expression by optimizing expression conditions.

Assisted in a construct archival project by checking DNA sequencing results using Sequencher and collating construct data for upload into the database.

QC Analyst (12/2007 – 07/2008) - QC Marketing Products- Commercial Product

Spectrophotometry: UV-Spec scan using gravimetric and volumetric sample preparation to determine the protein concentration of contents of in process, bulk, and final product samples.

General Tests: Color, Appearance and Clarity (CAC). Color, Opalescence and Clarity (COC). Standardizations for pH and pH testing. Osmolality.

Product ID testing:

oReverse phase HPLC (TNKase and Activase).

oIdentification by second derivative UV-spectroscopy Product (Lucentis).

oIdentification of rhDNase (Pulmozyme) by methyl green colorimetric test.

oIdentification of Liquid-formulated Growth hormone (Nutropin AQ), running electrophoresis mini gels.

Sodium/ Potassium Determination by Flame photometry

PhastSystem: SDS-PAGE, IEF gels

Novartis / Bayer Pharmaceuticals: Emeryville, CA:

QC Analyst I

(June 2007 – Sept. 2007) – Contract position

Responsible for performing Western blot analysis for IFN-Betaseron, TFPI (Tissue Factor Pathway Inhibitor), ELISA (Indirect Elisa) for screening TFPI/Placebo, Betaseron ELISA for screening IFN Betaseron/Placebo, ELISA for Harvest, Fractogel, and other in process samples in GMP and GLP compliant environment.

Responsible for data entry, data handling and data reporting.

Trained on Manual data recoding rules.

Requirement and procedure for GXP/ISO Training and cGMP and cGLP.

Responsible for inventory checks of reagents and performed audits to check calibration dates of equipments.

Dispensing and transferring empty vial and biohazard material properly.

Children’s Hospital of Oakland Research Institute (CHORI) Oakland, CA

Research Assistant

(Sept. 2004 – Jan.2005) - Contract position

Contributed to project on Gene therapy for inherited metabolic diseases. Worked on using murine genetics and murine models of human disease and adeno-associated viral vectors to deliver functional gene substitutes for the defective gene that causes diseases.

Worked on treatment of lysosomal storage diseases, MPS I and MPS VII, with new approach of genotyping techniques.

Responsibilities included identification of mutant mice. Conducting DNA assays, enzyme assays and PCR’s.

Assisted in diagnostic assays and genotyping.

EDUCATION:

Biotechnology Certificate Program (completed 2002), Ohlone College, Fremont, CA.

BS in Biology (completed 1999), R.C.C.V. Girls College, Ghaziabad, UP, India.

Clinical Research Associate (CRA) Certification (completed 2020), CRA Training Institute, Houston Texas, USA

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