Senior QC Review Specialist, QA, Bioanalytical, GLP, GMP

NEHA PATEL

732-***-****(C) • **********@*****.***

PROFESSIONAL EXPERIENCE

Sannova, Somerset, NJ 08/2023-11/2024

Title: Senior Quality Control Review Specialist

Supervise all Quality Control activities i.e. stage during method validation, sample analysis, final reports, and archival as per GLP. Train and manage the group members. Assign and follow up work of the group members daily for completeness.

Assign the timelines of projects as per contracts and manage the studies to deliver the results on time.

Perform technical review of data generated in support of GLP regulated work to ensure scientific accuracy and regulatory compliance.

Prepare and/or review validation and study reports. Update and review SOPs on need as basis.

Addressing clients comments and questions on reports and data. Create DTA (Data Transfer Agreement) templates as per client preference. Respond to QA audit comments on timely fashions.

Review and approve bioanalytical protocols, study plan, methods, reports, Memo to File, Laboratory Failure Investigation Report (LFIR), CAPA, and including deviations. Aquestive Therapeutics, Warren, NJ 10/2022-07/2023 Title: Analytical Scientist

Laboratory analysis of R&D drug substance and drug product. Method transfer and validation of analytical methods. Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations.

Prepare and update/review SOPs.

Ensure Data integrity and accuracy while adhering to SOP guidelines when peer reviewing. Maintain compliance with DEA and current GLP/GMP guidelines. Review/Qc of method validation, raw data, final report, chromatography and calculations of peers.

Schedule maintenance and calibrations of all lab instruments, ensuring it meets the GMP acceptance criteria.

Perform Chiral purity, Content Uniformity, Dissolution, KF, pH, and related substances and other assays.

SyneosHealth, Princeton, NJ 07/2021-09/2022

Title: Bioanalytical Scientist II

Bioanalytical research and development for detection of drug and metabolites in biological matrices.

Support projects through multiple stages of development. Analyze samples using various analytical methods for assays using variety of analytical techniques.

Contribute in GLP studies.

Peer review of Bioanalytical validation reports, logbooks, notebooks, and data generated by LC/MS/MS and making sure calculations and integration meets the acceptance criteria. Write, revise, and transfer deviations, methods, SOPs, and protocols. Design assay, request and maneuver within LIMS.

Perform full/partial Validations.

Proficient in and troubleshooting of analytical instrumentation (e.g. Shimadzu and Sciex LC/MS/MS systems, tomtec, and other lab instrumentations). Bert’s Pharmacy, Elizabeth, NJ 8/13-8/15 & 5/17-05/2021 Title: Manager

Setting up and starting a business

Marketing for the growth of the pharmacy

Applying for appropriate certifications

NJ Pharmacy law Compliance

Medication Inventory Management

Drug Classification and Safety

Envigo, Franklin Township, NJ 8/15-4/17

Title: Senior Bioanalyst

Develop, validate and analyze the samples in various assays within the Bioanalysis department. Report writing for validations

Reviewing peers data and calculations in detail for accuracy Review of Bioanalytical validation reports, logbooks, notebooks, and data generated by LC/MS/MS and making sure calculations and integration meets the acceptance criteria. Conduct all studies in accordance with GLP guidelines. Proficient in the conduct of method development, validation, sample analysis studies Proficient in the use of LIMS software and other data capture systems Perform accurate documentation and presentation of data Assist with preparation and review of authorized methods Perform all studies within the guidelines of the study protocols, SOPs and in compliance with the principles of GLP/GCP Write and review SOPs

Assist junior members of the staff to become proficient in LC-MS/MS assay techniques and departmental procedures

Merck & Co., Rahway, NJ 11/09 - 11/10

DMPK (Drug Metabolism)

Title: Scientist III

Conducting in-vitro metabolite identification in hepatocyte. Thawing and counting of cells under hemocytometer. Conducting hepatocyte incubations to study the metabolism of a compound Use of LC/MS/MS (Sciex/analyst/ 4000/Qtof)

Tuning compounds via Nanomate (Advion) and manually Running hepatocyte stability Assays

E LN, electronic notebook keeping

Generate datas, results, and compile reports and upload in database Roche, Nutley, NJ 10/02-3/08

Non-Clinical Drug Safety Group (NCDS)

Title: Scientist I

Bioanalytical research and development for detection of drug and metabolites in biological matrices (E.g. plasma, urine and tissue) to support projects through multiple stages of development.

Research and develop analytical methods for assays using variety of analytical techniques Contribute in GLP and Non-GLP studies

Design assays and studies in Watson LIMS

Validate methods for assay

Report writing in Rapid software and releasing of Data Peer review of Bioanalytical validation reports, logbooks, notebooks, and data generated by LC/MS/MS and making sure calculations and integration meets the acceptance criteria. Proficient in and troubleshooting of analytical instrumentation (e.g. Ultima, Quattro and Sciex LC/MS/MS systems, tomtec, and other lab instrumentations) Produce reports and present results, conclusion and implications to project teams and senior managements.

Discovery Chemistry

High Throughput Chemistry Group (HTC)

Title: Scientist I

Purify and Isolate synthesized compounds for Medicinal Chemistry, Combinatorial Chemistry, New Lead Chemistry Initiative Group, and Discovery Chemistry Group Method developing, optimizing and validating\Isolate\Purify crude compounds using Automated HPLC and LC/MS

Various HPLC/Software Used: Waters Delta Prep 4000, Lab Data Control System, Shimadzu

(Sciex-LC/MS), and Shimadzu (Class VP and Discovery-UV/VIS) Milligrams to Scale-up purification

Yearly, out-put of thousands of purified compounds Maintaining/Trouble-shooting HPLC and other instruments (Genevac, Savant, etc.) Pack columns in-house.

Novartis, Summit, NJ 6/01-10/02

Drug Discovery Group-Compound Management Department Title: Scientist

Create, distribute and manage libraries of compound by Solar Haystack system (Solution Archive), an automated system for dilution, storage and retrieval. Isolating/Purifying active fractions from Natural Product extracts for Oncology Research Fractionating the crude extracts (Plants/Marines)

Preparing entities for assay in High Throughput Screening Isolating/Purifying compounds via RP- HPLC (Waters- Varian/Rainin).

Merck Co., Rahway, NJ 10/00-6/01 Natural Product Drug Discovery-Merck Research Lab Title: Scientist

Prepare, distribute and inventory samples for medical research for Natural Product Drug Discovery group

Perform crude extractions (Fungal/ Marines/Plants) Prepare testable entities Used automation equipment to distribute samples

Participate in inventory management Prepare and maintain reserve materials Trouble-shooting

(Robotics)

EDUCATION

Kean University, Union NJ

Bachelor in Biology concentrated in Biotechnology, Minor: Chemistry

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