Vineeta Sharma
Edison,USA
Summary
Dynamic professional with over 15 years of expertise in analytical method development, and validation within the pharmaceutical industry. Extensive hands-on experience in laboratory operations, specializing in drug substance and drug product release and stability testing. Strong technical knowledge of GxP processes, quality audits, regulatory affairs, non-conformances and quality systems. Recognized for exceptional leadership abilities and a collaborative approach to teamwork while adeptly managing multiple tasks with minimal supervision.
Overview
2
2
Languages
1
1
Certification
17
17
years of professional experience
Work History
Associate Consultant, CMC
Biologics Consulting
01.2025 - Current
- Regulatory Writing Module 2 and 3 sections
- Mock PAI Audits
- Technical SME for Quality systems and Analytical methods
Senior Quality Control Manager
Actinium Pharmaceutical
08.2024 - 08.2025
- Conducted routine quality inspections to ensure compliance with industry standards.
- Developed and implemented quality control procedures for product testing.
- Collaborated with cross-functional teams to address quality issues and implement solutions.
- Managed CROs, CMOs and CTLs for DS, DP release and stability testing.
- Managed method development, qualification, validation, and Reference Standard qualification.
- Preformed data analysis, data verification and generated COA
- Managed OOS/OOT results, deviations and CAPA
- Authored Module 3 sections in IND, MAA and BLA applications
Quality Control Manager
Catalent
08.2022 - 06.2023
- Developed and implemented quality control procedures to enhance product reliability and safety.
- Trained team members on quality practices, fostering a culture of continuous improvement.
- Analyzed data from quality audits to identify trends and recommend corrective actions.
- Analytical method qualification and validation for drug substance, drug product and stability studies
- Supported technical transfer from PD lab or external sites to QC lab
- Managed internal and external audits
- Reviewed batch records, data verification, MSS and regulatory documents
- Managed change control, CAPA, deviations and lab investigations
- Supported IQ/OQ/PQ of QC equipment
- Managed scientists, senior scientists, and principal scientists
Technical Lead QC
KBI Biopharma
01.2021 - 07.2022
- Analytical method qualification and validation for drug substance, drug product and stability studies
- Supported technical transfer from PD lab or external sites to QC lab
- Managed internal and external quality audits
- Reviewed batch records, data verification, MSS and regulatory documents
- Managed change control, CAPA, deviations and lab investigations
- Supported IQ/OQ/PQ of QC equipment
- Managed and trained QC analysts
Senior Associate Scientist (Contract)
Celgene/Bristol Myers Squibb
01.2020 - 01.2021
- Developed and optimized assay protocols to enhance drug discovery processes.
- Implemented process improvements that increased efficiency in high-throughput screening workflows.
- Cancer biomarker new target discovery and validation.
- Used co-culture and other cell-based models to study effect of small molecules on cancer progression
Director of R&D and Quality
Biomed Diagnostics
07.2017 - 11.2019
- Led cross-functional teams to develop and implement strategic initiatives aligned with business goals.
- Oversaw budget management, ensuring effective allocation of resources across departments.
- Designed and executed quality assurance programs to enhance product reliability and compliance.
- Facilitated training sessions to improve team performance and operational efficiencies.
- Led the R&D department, worked in a cross-functional team and supported development and launch of DNA/RNA based IVD products
- Developed regulatory strategy during product development and post marketing phase
- Followed ISO 13485 and ISO 9001 guidelines
- Licensed new DNA/RNA and ELISA based diagnostic kits
- Developed regulatory strategy and prepared pre-sub package for 510(k) application
Product Development Scientist
Abeona Therapeutics
08.2013 - 07.2017
- Developed innovative formulations for gene therapies, enhancing product efficacy and stability.
- Executed comprehensive product testing protocols, ensuring compliance with regulatory standards.
- Streamlined R&D processes to optimize timeline efficiency and resource allocation.
- Devised new cell culture-based processes and refined existing ones to optimize biologics (AAV) manufacturing process
- Isolated AAV plasmid DNA to perform qPCR and ddPCR for plasmid quantification and yield
- Developed cell/RNA-based infectivity and other bioanalytical assays (ELISA, western blot, cell-based potency assay, enzymatic assay),
- Wrote study reports and protocols
- Wrote abstracts and presented data in scientific meetings
- Wrote CMC sections (Module 3) in IND applications
- Managed phase I, II and III clinical trials following GxP and CFR guidelines
- Managed and supported CMC activities (AAV/ biologics production and scale up) using bioreactors at a CMO in GMP and GLP environment
- Managed technicians and research associates
Postdoctoral Research Fellow
UCSF Benioff Children's Hospital Oakland
10.2009 - 07.2013
- Studied role of apoA5 (liver specific apolipoprotein) to regulate hypertriglyceridemia and liver diseases using AAV (biologics) based gene therapy
- Performed cloning and site directed mutagenesis to prepare wild type apoA-V and mutant constructs
- Used cell culture (HEK293) to prepare AAV and purified AAV vectors using column and density gradient methods
- Used various analytical techniques such as qPCR, silver staining and western blotting to characterize viral vectors
- Intravenous injection of AAV mediated apoA-V and mutants into apoa5 KO mouse
- Conducted surgeries to harvest mouse organs and isolated DNA/RNA/protein from mouse tissues
- Performed several analytical tests such as ELISA, PCR, DNA/RNA extraction, qPCR, sequencing, fragment analysis, flow cytometry, western blot, FPLC, HPLC and immune staining on plasma samples and mouse tissues
- Wrote lab protocols and procedures, research grants and biosafety protocols, manuscripts, abstracts, and presented data in scientific meetings
- Analyzed complex data sets using statistical software to identify trends and correlations.
- Trained research associates
Education
Ph.D. - Hematology
All India Institute of Medical Sciences
New Delhi, India04-2010
Master of Science - Biotechnology
CCS University
Meerut, India06-2003
Bachelor of Science - Life Sciences
CCS University
Meerut, India06-2001
Skills
- Quality Control
- Quality Assurance
- Quality Systems
- Quality Audits
- Analytical methods
- Data Analysis
- Stability studies
- Method validation
- Regulatory writing
- Training and mentoring lab analysts
Accomplishments
- Forte T.M., Sharma, V., Ryan, R.O. (2016) Apolipoprotein A-V gene therapy for diseaseprevention /treatment: a critical analysis. J. Biomed Res. 30, 88-93.
- Sharma V., Witkowski A., Witkowski HE, Dykstra A., Simonson J.B., Nelbach L.,Beckstead J.A., Pullinger C.R., Kane J.P., Malloy M.J., Watson G., Forte T.M., Ryan R.O.(2014) Aberrant hetero-disulfide bond formation by the hypertriglyceridemia associatedp.Gly185Cys APOA5 variant (rs2075291). Arterioscler. Thromb. Vasc. Biol. 34, 2254-60.
- Sharma, V., Beckstead J. A., Simonsen, J.B., Nelbach, L., Watson, G., Forte T.M. andRyan, R.O. (2013) Gene transfer of apolipoprotein A-V corrects the hypertriglyceridemicphenotype of apoa5 (-/-) mice. Arterioscler. Thromb. Vasc. Biol. 33, 474-80.
- Sharma V., Forte T.M., Ryan, R.O. (2013) Influence of apolipoprotein A-V on themetabolic fate of triacylglycerol. Curr. Opin. Lipidol. 24, 153-9.
- Sharma, V., Ryan, R.O., and Forte, T.M. (2012) Apolipoprotein A-V dependentmodulation of plasma triacylglycerol: A puzzlement. Biochim. Biophys. Acta. 1821, 795-9.
Certification
Certificate in Regulatory Writing Core Knowledge| 2025-Present
American Medical Writers Association (AMWA)
Certificate in Regulatory Documents| 2026
American Medical Writers Association (AMWA)
Languages
Hindi
Native or Bilingual
English
Native or Bilingual
Timeline
Associate Consultant, CMC
Biologics Consulting
01.2025 - Current
Senior Quality Control Manager
Actinium Pharmaceutical
08.2024 - 08.2025
Quality Control Manager
Catalent
08.2022 - 06.2023
Technical Lead QC
KBI Biopharma
01.2021 - 07.2022
Senior Associate Scientist (Contract)
Celgene/Bristol Myers Squibb
01.2020 - 01.2021
Director of R&D and Quality
Biomed Diagnostics
07.2017 - 11.2019
Product Development Scientist
Abeona Therapeutics
08.2013 - 07.2017
Postdoctoral Research Fellow
UCSF Benioff Children's Hospital Oakland
10.2009 - 07.2013
Ph.D. - Hematology
All India Institute of Medical Sciences
Master of Science - Biotechnology
CCS University
Bachelor of Science - Life Sciences
CCS University