Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Kreena Parekh

Redwood City,CA

Summary

Highly skilled and motivated professional in life sciences with an M.S. in biotechnology. Experienced in configuring LIMS and knowledgeable in cGMP and FDA regulations. Strong work ethic and assertive communication skills.

Overview

8
8
years of professional experience

Work History

Data Systems Manager LIMS & ELN

Vaxcyte, Inc.
San Carlos
09.2022 - Current
  • Project Leadership: Led a cross-functional project to gather and document end-user requirements for stability software, facilitating vendor selection and demonstrations to ensure alignment with business needs. Managed the GxP deployment, including validation activities and master data configuration.
  • Data Model Creation: Worked with multiple CMC teams to analyze in-process data and requirements for a centralized internal database, leading discussions to clarify business processes and facilitate database development.
  • Process Analysis and Documentation: Analyzed Vaxcyte processes and developed an Entity Relationship Diagram (ERD) to illustrate the end-to-end workflow, which was presented to senior management and utilized in the creation of Vaxcyte's data model.
  • ELN Support Leadership: As Team Lead, guided a team in providing ongoing support and administration of the ELN for CMC teams at Vaxcyte. The team also focused on understanding research workflows and facilitating the deployment and implementation of Benchling ELN for the research team.
  • Benchling ELN Implementation: Played a key role in the implementation of the Benchling ELN for all CMC teams, providing comprehensive training to end users to ensure effective adoption.
  • Administrative Support: Acted as a system administrator for Benchling ELN, providing operational support and managing functions related to workflow management, template creation, SQL query setup, accounts, and permissions management.

Manager QC Laboratory Systems

Elevate Bio
Waltham, MA
04.2021 - 09.2022
  • GxP LIMS Implementation: Coordinated the deployment of LIMS modules, including Batch/Sample Management, Stability, Environmental Monitoring (EM), and Laboratory Execution System (LES), ensuring compliance with GxP standards.
  • Validation Collaboration: Worked closely with validation and QA teams to create validation plans, test scripts, SOPs, and a comprehensive validation summary report for the LIMS system.
  • Business Process Documentation: Analyzed and documented the company's unique business model, defining departmental structures, roles, and permissions for system configuration.
  • Master Data Management: Configured and maintained master data in the LIMS system to streamline laboratory operations, stability testing, and environmental monitoring processes.
  • End User Training: Conducted training sessions for end users across multiple departments, providing thorough instruction on LIMS functionality and best practices.
  • User Support and Engagement: Established a consistent meeting cadence to address user inquiries and challenges related to the LIMS system, fostering a supportive environment.
  • Stakeholder Communication: Facilitated effective communication between stakeholders and vendors to develop electronic reports, including sample testing reports, barcode label printing, certificates of analysis, and stability protocols.
  • Integration Workflow Development: Collaborated with SAP and MES stakeholders to design integration workflows, enhancing data flow and operational efficiency within the LIMS.

Associate Software Engineer

Moderna Inc
Norwood, Massachusetts
08.2017 - 04.2021
  • GxP Systems Management: Aided in managing and maintaining various digital GxP systems, including LIMS, ensuring compliance and data integrity.
  • Master Data Oversight: Managed the creation and maintenance of master data changes in LIMS, including specifications, test methods, stability protocols, alert limits, and more.
  • Documentation and Compliance: Ensured data integrity and GDP compliance by documenting changes, updates, and access requests within ITSM software.
  • LES Deployment: Collaborated with end users to gather requirements and deploy the Lab Execution System (LES) module, streamlining operations for Analytical Development and Quality Control teams.
  • Data Transfer Optimization: Implemented a tailored SDMS parser solution for efficient data transfer from Chromeleon to the LES module of LIMS.
  • EM-LIMS Integration: Streamlined integration of instruments with Environmental Monitoring (EM) LIMS for endotoxin testing, particulate counting, and TOC analysis, including implementation of compliance reports.
  • MES and LIMS Integration: Conducted dry runs to support the successful implementation of bi-directional integration between MES and LIMS.
  • User Experience Enhancements: Contributed to LIMS web page designer changes and ensured ongoing system enhancements to improve end-user experience.
  • Version Upgrade Support: Assisted in the successful version upgrade and revalidation of the LIMS system, maintaining compliance with regulatory standards.
  • Training and Support: Collaborated with cross-functional teams to resolve LIMS-related issues, providing regular training sessions and ongoing ad hoc support to enhance user experience.
  • Regulatory Compliance Reviews: Guaranteed adherence to regulatory standards through periodic reviews of various GxP software.

Research Intern

Georgetown University
Washington, DC
11.2016 - 07.2017
  • Cell Culture and Bioreactor Operations: Contributed to scaling up eukaryotic cell culture processes and producing recombinant protein R-spondin-1 using a Hollow Fiber Bioreactor.
  • Protein Analysis and Purification: Demonstrated proficiency in protein analysis and purification techniques, including affinity chromatography and Western blotting.
  • ELN Template Development: Developed user-friendly electronic lab notebook (ELN) templates for pH and conductivity tests, enhancing data documentation and accessibility.

Education

Master of Science - Biotechnology

Georgetown University
Washington, DC

Bachelor of Technology - Biotechnology

D.Y.Patil University
India

Skills

  • LIMS/ ELN Implementation (LabVantage, MODA, Novatek Stability, Benchling)
  • Process Mapping, Requirement Gathering and Workflow Optimization
  • Data Modeling and ERD Creation
  • Comprehensive knowledge of 21 CFR Part 11 and GxP Standards
  • Vendor and Stake holder Liaison
  • Adaptability and Attention to Detail
  • Problem solving and Critical Thinking
  • Ability to Multitask in a fast paced Environment

Accomplishments

Publications:

  • Media optimization in immobilized culture to enhance the content of Karmpferol in Tylophora indica (Asclepeadaceae) and Curcumin in Curcuma longa (Zingiberaceae). - IOSR Journal of Pharmacy and Biological Sciences, 9(2), 86-90.
  • Kaempferol and Stigmasterol content variations in diverse Cowpea (Vigna unguiculata) seed varieties. -Vedic Research International Phytomedicine VRI-PM, 2(2),48.

Timeline

Data Systems Manager LIMS & ELN

Vaxcyte, Inc.
09.2022 - Current

Manager QC Laboratory Systems

Elevate Bio
04.2021 - 09.2022

Associate Software Engineer

Moderna Inc
08.2017 - 04.2021

Research Intern

Georgetown University
11.2016 - 07.2017

Master of Science - Biotechnology

Georgetown University

Bachelor of Technology - Biotechnology

D.Y.Patil University

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Kreena Parekh