Senior Quality Control & Lab Team Lead

NEHA PATEL

Middlesex, NJ

732-***-**** • **********@*****.***

PROFESSIONAL EXPERIENCE

Independent Consultant/Professional development (10/25-present)

Executed self-directed projects focusing on social media.

Overcame technical challenges.

Independently researched solutions and mastering new tools

Consult and provide best outcomes.

Labcorp, Raritan, NJ (06/2025–09/2025)

Team Lead – Chemistry

Oversee the daily functions of the Chemistry department, maintaining efficient operations and ensuring exemplary patient care.

Prepare and send production reports to management on a daily, weekly, and monthly basis.

Assist with onboarding and training new hires, as well as supporting current employees.

Evaluate specimens for testing based on established acceptance criteria.

Perform technical procedures, both routine and complex according to SOPs.

Monitor, operate, and troubleshoot laboratory instruments (Roche) to maintain optimal functionality.

Prepare, test, and assess new reagents/controls, and report test results accurately.

Work in compliance with CLIA regulations.

Sannova, Somerset, NJ (08/2023–01/2025)

Senior Quality Control Review Specialist

Supervise all Quality Control functions, including method validation, sample analysis, report finalization, and archival, adhering to GLP, ICH M10, and FDA guidelines.

Manage multiple projects concurrently.

Train and oversee team members, assign tasks, and ensure work completion.

Establish project timelines in alignment with contract requirements, ensuring timely delivery of results, data, and reports.

Address client feedback and questions concerning reports and data, ensuring effective communication.

Develop Data Transfer Agreement (DTA) templates tailored to client specifications.

Respond promptly to QA audit comments.

Conduct internal audits of studies and validations to uphold quality standards.

Review and approve bioanalytical protocols, study plans, methods, study and validation reports, Memo to File, Laboratory Failure Investigation Reports (LFIR), SOPs, CAPA, and deviations.

Aquestive Therapeutics, Warren, NJ (10/2022–07/2023)

Analytical Scientist

Perform laboratory testing of research and development pharmaceutical products in accordance with DEA and GLP/GMP regulations.

Perform various assays, including Chiral purity, Content Uniformity, Dissolution, Karl Fischer (KF), pH, Permeation and related substances.

Transfer and validate analytical methods.

Provide analytical support for pre-formulation, formulation development, and prototype manufacturing.

Review and quality check method validation, final reports, and chromatography (Empower), confirming data integrity and adherence to SOP guidelines during peer review.

Schedule maintenance and calibration of laboratory instruments, ensuring compliance with GMP standards.

SyneosHealth, Princeton, NJ (07/2021–09/2022)

Bioanalytical Scientist II

Perform research and development to identify drugs and metabolites within biological matrices.

Perform analyses with various techniques while ensuring GLP regulations.

Peer review bioanalytical validation reports, logbooks, notebooks, and LC/MS/MS data, verifying calculations and integration meet acceptance criteria.

Write, revise, and transfer deviations, methods, SOPs, and protocols.

Perform full and partial method validations.

Diagnose and resolve technical issues with analytical instruments, such as Shimadzu and Sciex LC/MS/MS systems, Tomtec, and other laboratory equipment.

Bert’s Pharmacy, Elizabeth, NJ (08/2013–08/2015 & 05/2017–05/2021)

Manager

Initiate and oversee all business operations.

Develop and implement marketing strategies to drive pharmacy growth.

Supervise medication inventory, ensuring proper classification and safety.

Train and supervise employees and prioritize patient care,

Envigo, Franklin Township, NJ (08/2015–04/2017)

Senior Bioanalyst

Develop, validate, and analyze samples in various assays within the Bioanalysis department.

Perform method development, validation, and sample analysis in accordance with GLP guidelines

Review peer data and calculations for accuracy.

Evaluate bioanalytical validation reports, logbooks, notebooks, and LC/MS/MS data, ensuring calculations and integration meet acceptance criteria.

Utilize LIMS software and other data capture systems.

Merck, Rahway, NJ (11/2009–11/2010)

Scientist III

Conduct in-vitro metabolite identification in hepatocytes.

Thaw and count cells using a hemocytometer.

Perform hepatocyte incubations to study compound metabolism.

Utilize LC/MS/MS (Sciex/analyst/4000/Qtof) for analytical assessments, tuning compounds via Nanomate (Advion).

Run hepatocyte stability assays and maintain electronic notebook documentation.

Generate data, compile results, and upload reports into the database.

Roche, Nutley, NJ (10/2002–03/2008)

Scientist I

Conduct bioanalytical research and development for detection of drugs and metabolites in biological matrices such as plasma, urine, and tissue, supporting projects through multiple development stages.

Develop analytical methods for assays using a range of techniques.

Contribute to GLP and Non-GLP studies.

Design essays and studies in Watson LIMS.

Perform method validation and review bioanalytical validation reports, logbooks, and LC/MS/MS data, ensuring calculations and integration meet acceptance criteria.

Troubleshoot analytical instruments, including Ultima, Quattro, and Sciex LC/MS/MS systems, Tomtec, and other lab equipment.

Novartis, Summit, NJ (06/2001–10/2002)

Scientist

Create, distribute, and manage compound libraries using the Solar Haystack system (Solution Archive), an automated platform for dilution, storage, and retrieval.

Isolate and purify active fractions from plant and marine extracts for Oncology research.

Prepare entities for high-throughput screening assays and purify compounds using RP-HPLC (Waters-Varian/Rainin).

Merck, Rahway, NJ (10/2000–06/2001)

Scientist

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

Perform crude extractions from fungal, marine, and plant sources.

Utilize automation equipment for sample distribution and troubleshoot equipment issues.

EDUCATION

Kean University, Union NJ

Bachelors in Biology, concentrated in Biotechnology, and Minor in Chemistry

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