I bring over 20+ Years of Pharmaceutical/Biotech industry experience. I have had the opportunity to build IT infrastructure, Manufacturing facility, QC and R&D Labs from ground up.

I Managed multimillion dollar (~12M) projects to build out MFG systems, QC, and R&D labs systems, that included projects such as LIMS, ELN, and MES along with Disaster recovery systems. Very well versed in computer systems validation principles and system life cycle deliverables.
As a PM I was responsible for:
             Communication and reporting on the project status, scope management, schedule management, resource management, budget management, and risk management.
As a PM and System Owner/Product owner of LIMS and ELN
o  Implemented Benchling ELN for Translational Science Lab.
o  Implemented LabWare LIMS and ELN for QC Lab and MFG.
o  Implemented LIMS EM module and LIMS – CLIMET interface for Microbiology lab.
o  Manage a LIMS core team that includes LIMS developer, DBA and LIMS administrator.
o  Transitioned all calculated Excel spreadsheets in ELN for improving Data security and Integrity.
o  Mapped out current Laboratory process flow for LIMS Product Lot management implementation.
o  Managed all LIMS related Validation documents (i.e. URS, FRS, CS, Validation scripts, Trace Matrix, Validation summary reports and SOPs)
o  Work with IT infrastructure to test and implement security patches and system upgrades.
o  Work with Business partners to continuously improve LIMS/ELN systems.

Built and managed teams of Lab / MFG administrators, LIMS/ELN developers, Data integrity/data security, and DBA for GxP and R&D labs.    
·      Created a lab data governance model.
·      Created support model for Labs (instrument support, and software support)
·      Successful completion of EU (EMA) inspections.
·      Successful completion of Internal Pre-approval inspection (PAI) inspections.
o  Built the Atara Labs (QC, PS, TS, R&D) and MFG in process testing facility from ground up.
o  Work with Vendor and business to implement testing instruments.
o  In charge of implementation, Validation and Administration of all Lab Systems.

Sr. Project Manager

Managed LIMS development and lab informatics Projects.
Project manager for Thermo Scientific (Sample Manager 12.0) LIMS implementation and Waters Empower 3 Chromatographic data system &#40;CDS&#41; implementation.
·      Mapped out current manufacturing and laboratory process flow for LIMS implementation.
o  Participated in LIMS vendor selection process.
o  Gathered user requirements for LIMS.
o  Configuration and Validation of LIMS.
·      Established lab informatics administration and quality processes to ensure data integrity.
·      Managed lab informatics team to ensure data security and integrity.
·      Continuous improvement of quality processes.
·      Handled/oversaw Empower 3 configuration, administration, and training.
·      Performed various tasks for computer system validation for Empower 3 and various Lab instruments as member of Quality IT group.
o  Implemented system backup policies and created/updated Quality SOPs

Sr. Lab informatics Specialist	/ Project Manager

As a Project Manager I worked on LIMS, ELN and OpenLab CDS implementation.
Managed LIMS development and Lab data integrity team.
System owner of Edwards LIMS and ELN and OpenLab CDS.
·      Implementation of LabWare LIMS and ELN.
o  Worked with Software Quality to Validate the LabWare LIMS V6
o  Conducted gap analysis between web LIMS and Client LIMS and as a result authored regression testing to ensure smooth transition from web to client LIMS.
o  Authored IOPQ scripts for this project.
o  Configured/maintained master data; updated and conducted training for LIMS SOPs
·      Part of a core team for Electronic Lab Notebook (ELN) implementation for EQL Labs.
o  Developed/validated ELN templates, and configuration of master data. 
o  Authored various validation documents including IOPQ and SOPs
·      Managed Lab data integrity and data security team.
o  Audited lab systems to ensure they met data integrity standard and were in compliance in accordance with 21 CFR part 11.
·      Responsible for deviations and CAPAs for Lab systems.
·      Integral part of implementing new Design Qualification (DQ) for EQL labs.
o  Involved in design of the workflow and development of the DQ process and in scripting URS, FRS, IOPQ, and PPQ
·      Configured/validated enhancements to the LIMS system as continuous improvement to the DQ process. Worked with software quality to ensure the continuous validity of the system.
·      Successfully implemented Agilent’s open lab system, responsible for Validation, system configuration and administration.

Analyst, Lab Systems / Project Manager

Nishant Bhatt

English

Native or bilingual proficiency

Gujarati

Full professional proficiency

Hindi

Project Manager

Head of IT

Sr. Director, Information System

I have worked with Nishant on a number of projects and have found him to be extremely capable, professional and very easy to work with. He has been instrumental on the ability to lay out and perform the tasks needed from his groups ensuring the successful reach of milestones and ultimately the success of the entire projects. He has the ability to not only grasp the urgency of things but also think outside of the box and come up with quality solutions. He is easy to communicate with and always ready to constructively discuss issues and ideas. I would not hesitate to ever work with him again or ask him to lead any of my projects in the future. He would be a great addition to lead or be part of a team.

Nishant Bhatt

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