Rakesh Deshpande

Lab IT Systems Specialist

Customer: Leading Manufacturer of Novel Cancer Medicines

• Acting as the IT Instrument Owner, coordinating closely with business process owners, vendors, and IT support teams (Desktop support, Networking) to ensure seamless performance and support of critical laboratory instruments.
• Leading the IT assessment and management of instrument software, conducting regular reviews on performance, upgrades, new requirements, and system integrations, ensuring compliance with 21 CFR Part 11, Data Integrity, Backup, Disaster Recovery, and Validation requirements.
• Collaborating with business users to gather information on new instruments for procurement, conducting thorough assessments of the associated software, ensuring security, regulatory compliance, and validation needs are met.
• Leading IT-driven validation activities, including drafting and reviewing User Requirements Specification (URS), Functional Requirements Specification (FRS), Functional Risk Assessments (FRA), Design Specifications (DS), and performing Installation and Operational Qualification (IOQ).
• Coordinating with vendors and internal teams to track software upgrades, patches, and maintenance for a variety of instruments, including Flow Cytometers, qPCR machines, Microplate Readers, Automated ELISA Readers, and Nano Drop spectrophotometers.
• Delivering ITIL-based Tier 2 and Tier 3 support for instrument software applications, managing tickets in ServiceNow and ensuring all issues are resolved within Service Level Agreements (SLA).
• Serving as the Single Point of Contact (SPOC) for the customer, representing Cognizant, and providing site service status reports, outlining project progress, achievements, and risks to key stakeholders.

Key Project: Global Implementation of FCS Express for Flow Cytometry Data Processing

• Leading the IT process from planning to release, managing impact assessments, change control, and validation activities such as reviewing URS, drafting FRS and FRA, and developing Architecture Design Specifications.
• Developing and qualifying system configurations, performing Installation and Operational Qualification (IOQ), and ensuring software fixes and maintenance are implemented.
• Collaborating with cross-functional teams (QC, Networking, Project Management) and external vendors to support configuration, validation, access management, and software maintenance throughout the implementation.

Key Achievements:

• Successfully qualifying a range of instrument software, including Flow Cytometers, ensuring full compliance with regulatory and internal standards.
• Developing comprehensive support plans for multiple instrument software systems, ensuring long-term sustainability and performance.
• Consistently resolving incidents and requests within the defined SLAs, achieving 100% compliance.

Empower3 and Labware LIMS Implementation.

Customer: Reputed Pharmaceutical CDMO

• Actively contributed to the global implementation of Empower3 Chromatography Data System (CDS) for a customer, facilitating the upgrade from a legacy CDS system and ensuring effective interfacing with Labware LIMS across multiple sites in the USA, Europe, and South America.
• Played a key role in planning the implementation at U.S.-based sites while located at the Kansas City facility, contributing to system integration and rollout strategies, including system impact assessments and change control.
• Conducted thorough assessments on instruments, driver compatibility, custom fields, and processing and reporting methods to ensure seamless migration and system functionality.
• Collaborated with Networking, Desktop Support teams, Waters (Vendor), QC business users, and Labware (Vendor) to successfully configure and validate the Empower-Labware LIMS interface.
• Participated in project review meetings as a subject matter expert, presenting progress on deliverables, discussing achievements, and identifying risks to ensure proactive issue resolution.
• Provided expertise in validation planning, developing, and reviewing User Requirements Specification (URS), Functional Requirement Specification (FRS), Design Specification (DS), and executing Installation and Operational Qualification (IOQ).
• Conducted functional risk assessments to identify potential issues and ensure compliance throughout the project lifecycle.
• Delivered hypercare support post-validation, ensuring a smooth transition and optimal system performance after the system release.

Key Achievements:

• Developed complex custom fields and fully automated data processing and reporting workflows within Empower, significantly enhancing system efficiency.
• Configured and qualified over 100 diverse instruments, including HPLC, GC, Ion Chromatography, UPLC, Capillary Electrophoresis, ELSD, and ThermoCAD, ensuring full integration with Empower3.
• Tackled multiple technical challenges through proactive problem-solving and cross-functional collaboration, ensuring adherence to project timelines and quality standards.
• Recognized for resolving critical technical issues, demonstrating exceptional technical knowledge, and strong consultation skills throughout the implementation process.

Business Analyst - Empower CDS and Labware LIMS

Customer: Reputed Pharmaceutical CDMO

• Acting as a business analyst for the Empower Chromatography Data System (CDS) and Labware LIMS, responsible for developing and validating custom fields in Empower to automate chromatography calculations.
• Collaborating with business users to gather requirements, designing and configuring complex formulae such as intersample summary calculations, boolean expressions, and limit tab calculations.
• Developing and configuring custom fields, processing methods, and report methods within Empower to streamline and automate the calculation and reporting processes.
• Drafting and executing Installation and Operational Qualification (IOQ) protocols for testing custom fields functionality using digital validation tools like HP ALM.
• Leveraging strong expertise in Empower CDS and Labware LIMS to develop and validate an interface between the two systems, ensuring seamless data transfer and integration.
• Configuring LIMS templates and mapping data fields to support accurate and efficient data exchange between Empower CDS and Labware LIMS.
• Gaining hands-on experience with Agile methodology for software implementation, utilizing JIRA for tracking project progress, and managing deliverables.
• Participating in project review meetings, providing updates on custom field development, validation progress, and the LIMS interface implementation, while identifying and mitigating risks.

Key Achievements:

• Successfully developed and validated complex custom fields in Empower, fully automating calculations, and improving overall process efficiency.
• Played a critical role in developing and qualifying the Empower-LIMS interface, ensuring smooth integration and data accuracy.
• Expanded expertise in SDLC, Agile methodology, and tools like HP ALM and JIRA further enhance project management and validation capabilities.

Quality Control Associate.

Dr. Reddy's Laboratories Limited

Project: Labware LIMS Implementation.

• Provided key contributions as part of the Labware LIMS implementation project, while continuing to fulfill routine QC responsibilities.
• Configuring master data in Labware LIMS across multiple modules, such as Lot Management, Sample Flow, Inventory Management, Instrument Interfacing, Empower CDS interface, and Batching.
• Established interfaces for standalone instruments (e.g., UV Spectrophotometers, Weighing Balances, pH Meters, Electrophoresis) by parsing data into Labware, ensuring seamless data integration.
• Developed and qualified custom fields for chromatography calculations in Empower CDS, drafted and executed Installation and Operational Qualification (IOQ) protocols.
• Drafted key validation documents, including User Requirements Specification (URS), Functional Requirements Specification (FRS), Configuration Specification (CS), and conducted Functional Risk Assessments (FRA).
• Executed Site Acceptance Testing (SAT) and User Acceptance Testing (UAT) scripts to validate system functionality.
• Acted as a subject matter expert in project review meetings, providing updates on deliverables, and addressing project risks.
• Provided post-implementation support for Labware LIMS, resolving technical issues in collaboration with IT and vendors, and worked on system maintenance and enhancements.

Routine QC Responsibilities.

• Performed quality testing on samples, including process intermediates, drug substances, and drug products, ensuring compliance with specifications and conducting stability studies.
• Specialized in chromatography analysis, handling Reverse Phase HPLC (RP-HPLC), Size Exclusion HPLC (SE-HPLC), Ion Exchange HPLC (IEX-HPLC), Peptide Mapping, and Glycan Analysis.
• Conducted other analyses, such as spectrophotometry, SDS-PAGE, capillary electrophoresis, PCR, and ELISA, ensuring accurate and reliable results.
• Collaborated with Analytical Science and Technology (ASAT) teams, participating in method validation and transfer activities, with a focus on chromatography techniques. Conducted gap assessments and harmonized analytical methods.
• Reviewed and verified analytical data for compliance with GMP, GDP, and Data Integrity principles, ensuring adherence to ALCOA+ guidelines. Addressed non-compliance issues and worked closely with sample management teams for timely release of analytical data.
• Authored, reviewed, and approved key GMP documents (e.g., Test Methods, SOPs, Validation Reports) using the Electronic Document Management System (EDMS). Managed the onboarding, qualification (IQ, OQ, PQ), calibration, and maintenance of analytical instruments (HPLC, UPLC).
• Acted as a Point of Contact (POC) and liaison with vendors, IT, and Validation departments to ensure the smooth operation and qualification of laboratory equipment.

Audits and Meetings.

• Participated as a chromatography subject matter expert in audits by international regulatory bodies (MoH Russia, Ukraine, CDSCO, ENVISA), and internal audits.
• Led daily Lab Development Meetings (LDM) to discuss key metrics on productivity, quality, and safety, resolve roadblocks, and track the progress of ongoing issues.

Investigations and Continuous Improvement.

• Conducted root cause analyses for deviations and failures, implementing Corrective and Preventive Actions (CAPA) to prevent recurrence.
• Provided technical expertise in addressing quality deviations, performing impact assessments, and supporting change implementation efforts.
• Led calibration and periodic maintenance of laboratory instruments and acted as the point of contact for HPLC qualifications, collaborating with vendors to onboard and qualify new instruments.

Key Achievements:

• Successfully implemented Labware LIMS, enhancing process efficiency by achieving seamless integration and full automation of data transfer.
• Automated chromatography calculations through the development of complex custom fields and reporting methods.
• Gained strong expertise in Empower CDS and chromatography methodologies, along with extensive experience in GMP, ICH, FDA, and 21 CFR Part 11 regulations.

Analytical Scientist - Biopharmaceutical Analytical Methods.

Syngene International Limited.

• Analytical Method Development: Developed methods for chromatography techniques including Size-Exclusion HPLC (SEHPLC), Reverse Phase HPLC (RPHPLC), Ion Exchange HPLC (IEX HPLC), Peptide Mapping, and biochemical techniques such as SDS-PAGE, Western Blotting, UV-Spectrophotometry, and ELISA for testing biopharmaceutical drug substances (DS) and drug products (DP).
• Analytical Method Validation: Led validation efforts, ensuring methods adhered to ICH guidelines for repeatability, accuracy, linearity, precision, and robustness. Validated methods were used for routine testing and stability studies.
• Cell-Based Assays: Developed and validated cell-based assays for testing biological activity, ensuring reliability and consistency in results.
• Cell Culture Techniques: Managed cell passaging, freezing, thawing, and cell counting, and worked in sterile environments using biosafety cabinets.
• Regulatory Compliance: Applied knowledge of USP, FDA, and ICH guidelines to ensure compliance in pharmaceutical product development.

Key Achievements:

• Successfully developed and validated critical analytical methods for testing biopharmaceuticals, ensuring accuracy and compliance with ICH guidelines.
• Established reliable cell-based assays, improving assay reproducibility and efficiency for biological activity testing.
• Led stability studies, contributing to the long-term quality assurance of biopharmaceutical substances and products.
• Recognized for ensuring compliance with regulatory guidelines during method validation, maintaining high standards in drug substance and product analysis.

Monoclonal Antibody Development Specialist.

Bioneeds India Private Limited.

• Monoclonal Antibody Development: Developed Monoclonal Antibodies (mAbs) from mice using Hybridoma Technology, encompassing all stages from immunization to cell culture, clone identification, and purification.
• Antibody Production: Managed the production and purification of antibodies from various animal models, including mice and rabbits, focusing on antigen formulation and extraction techniques.
• Analytical Techniques: Utilized advanced methodologies for the characterization of mAbs, including Protein-A column purification, ELISA, SDS-PAGE, Western Blotting, UV-Spectrophotometry, and Mass Spectrometry.
• Cell Culture Expertise: Maintained proficiency in cell culture techniques, ensuring the viability and functionality of hybridoma cells throughout the development process.

Key Achievement:

• Gained hands-on experience in developing and characterizing mAbs, enhancing my expertise in antibody production and purification techniques.

Project Trainee

Abexome Bioscience Pvt Ltd.

• Contributed to the development of monoclonal antibodies targeting human cell cycle proteins using the Hybridoma technique.
• Gained hands-on experience in laboratory analytical techniques, including ELISA, SDS-PAGE, Western Blotting, protein purification, and cell culture.