Siddharth Krishnan Email & Phone Number

Boston, Ma, Us

Waltham, Ma, Us

Serve as Manager, Quality Assurance and Supplier Quality Management for the Supplier Quality Group at Viral Vector Services. Work closely with QCRM team, with Quality oversight of QC Raw Material testing, review and Disposition.Duties and Responsibilities (Including all QA Manager duties listed in previous role):Supplier Quality Management:⚪ Manage a group of Quality Specialists who ensure the Quality of Materials and GMP Quality oversight of the Supply Chain Function. ⚪ Oversee the team responsible for all Supplier Quality Management activities across all VVS sites, including:⚪ Onboarding of New Suppliers: Perform Supplier Evaluation and Risk Assessment on all new material requisitions prior to approval for onboarding by VVS.⚪ Establishment of Quality Agreements: Responsible for the establishment and update of all Supplier Quality Agreements between VVS and external Suppliers/Service Providers.⚪ Supplier Audit Planning and Oversight: Identify all new and approved Suppliers requiring Audits to be performed on an ongoing basis.⚪ Vendor/Supplier Change Notifications (VCN/SCNs): Process and assess Supplier Change Notifications and execute remediation actions using the Change Control process.⚪ Supplier Corrective Action Requests (SCARs): Issue and follow up on Supplier Complaints and Corrective Action Requests caused due to raw material defects. ⚪ Maintain and update the Approved Supplier Lists across multiple clients on an ongoing basis.⚪ Liaise with Global Supplier Quality to align on Quality Agreement establishment, communicate Audit requests and escalate SCN and SCARs.⚪ Maintain and update all VVS Supplier Quality Records on an on-going basis.⚪ Conduct Re-qualification activities of Suppliers on a periodic basis. ⚪ Serve as the SME for all Supplier Quality Management issues during Regulatory and Client Inspections/Audits.See QA Manager role below for Quality Assurance Duties and Responsibilities:

Waltham, Ma, Us

⚪ Manage a group of Quality Specialists who ensure the Quality of Materials and GMP Quality oversight of the Supply Chain Function.⚪ Responsible for the Quality oversight of Supply Chain and Warehouse Operations to ensure compliance during daily operations.⚪ Perform and oversee the complete review and approval of Raw Material Batch Records, followed by Raw Material Batch Disposition on a daily basis.⚪ Review/Approve Quality records such as Deviations, Investigations, CAPAs, Change Controls and other quality documentation as required.⚪ Review and Approve Controlled Documents such as SOPs, Specifications, forms etc., using the electronic Documentation Management System.⚪ Escalate issues with urgency and propose solutions to resolve the issue(s) in a timely manner. ⚪ Lead meetings focused on quality items, material related projects, day to day GMP oversight and client related topics. ⚪ Responsible for driving continuous improvement in the quality function. ⚪ Perform the monitoring of the Warehouse through periodic walkthroughs, logbook reviews and final product transfer oversight from the quality perspective.⚪ Ensure regulatory and customer inspection readiness on a continuous basis.⚪ Represent QA during agency and client Audits by participating in Warehouse Tours and liaising with Auditors as an SME during inspections.⚪ Document work clearly, accurately, and in accordance with CGMP. ⚪ Meet changing demands to support manufacturing activities. ⚪ Complete tasks where judgment is required in resolving problems & making recommendations. ⚪ Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner. ⚪ Plan group activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.

New York, New York, Us

Serve as the Quality Assurance Manager for the NYPH Cellular Therapy Laboratory.Job responsibilities:⚪ Ensure the Cellular Therapy Laboratory at NYPH adheres to the Quality Management Plan (QMP) and the requirements of accrediting (FACT, CAP) and regulatory agencies (FDA, NYSDOH).⚪ Navigate the CT Lab through Inspection, Accreditation & Audit events by serving as the key Liaison between the lab and external agencies.⚪ Ensure data and documentation systems are consistent with current Cellular Therapy Laboratory SOPs.⚪ Responsible for writing and developing Quality Monitors in response to the needs of the laboratory QMP and accrediting/regulatory bodies.⚪ Prepare reports of Quality Monitors on a monthly, quarterly and annual basis which are presented to stakeholders at cross-functional team meetings.⚪ Responsible for assessing the continuous compliance of the laboratory through the monitoring of Proficiency Testing and Employee Competencies.⚪ Perform scheduled Audits and conduct Root Cause Analyses for Laboratory Events.⚪ Ensure Change Control policies are in place and are adhered to by laboratory personnel.⚪ Work cooperatively with cross-functional teams to ensure adherence and compliance with regulatory requirements.⚪ Present Laboratory QA data at monthly, quarterly and annual meetings held at an intra, inter and institution wide level.Projects and Assignments:⚪ Project Manager - Stemsoft LIS development, customization, validation and implementation.⚪ Validation Leader - Epic EMR validation, roll-out and post-implementation troubleshooting.⚪ Department Champion/Administrator - SoftTech DMS Training & Competency module training, implementation and migration from existing paper based system.⚪ Inspector - Inter departmental laboratory audits.⚪ Member and Contributor - Quality Improvement Workgroup, Laboratory Safety Committee.⚪ CT Lab management team member- Tasked with transforming the research facility into a cGMP compliant laboratory facility.

New York, Ny, Us

Administrative Duties ⚪ Coordinate daily operations of the QC cGMP laboratory by assigning duties to junior technologists ⚪ Review test results for release and confirm the accuracy of data transfer ⚪ Train technologists in equipment operation and performance of procedures in compliance with SOPs ⚪ Troubleshoot and maintain all laboratory computers and electronics ⚪ Compile, organize and file Microbiology QC & Positive culture results and reports ⚪ Manage Inventory by ordering supplies using the Lawson e-requisition software ⚪ Coordinate laboratory equipment calibration and preventive maintenance ⚪ Record and monitor reagent expiration dates o Monitor laboratory and equipment microclimates using the ISENSIX monitoring systeem.⚪ Analyze and interpret sample data to assess changes in cord blood viability Lab Management Duties ⚪ Execute validations of laboratory processes and the implementation of new assay methods.⚪ Investigate out of specifications (OOS) results and implement corrective and preventive actions ⚪ Perform proficiency testing of laboratory assays conducted by the College of American Pathologists ⚪ In charge of In-house reagent production, validation and Quality Control testing prior to release ⚪ Involved in QC analysis of cord blood product during periodic Stability testing procedures ⚪ Trained to conduct Environmental monitoring and Sterility testing of clean room facilities.Technical Duties ⚪ Responsible for the operation and maintenance of the QC Hematology, Microbiology, Cell Culture and Molecular diagnostics laboratories

New York, Ny, Us

Management Duties ⚪ Coordinate daily operations of the QC cGMP laboratory by assigning duties to junior technologists ⚪ Train technologists in equipment operation and performance of procedures in compliance with SOPs ⚪ Troubleshoot and maintain all laboratory computers and electronics ⚪ Oversee the follow up and filing of Microbiology reports and results ⚪ Order and restock supplies using Lawson e-requisition software ⚪ Coordinate laboratory equipment calibration and preventive maintenance ⚪ Record and monitor reagent expiration dates ⚪ Maintain and monitor laboratory and equipment microclimates using the ISENSIX monitoring system Laboratory Duties ⚪ Perform cord blood QC testing in the Hematology, Microbiology, Cell Culture and Molecular diagnostics ⚪ Conduct Hemoglobinopathy screening on cord blood samples using the Bio-Rad Variant HPLC system ⚪ Perform DNA extraction and quantification studies on cord blood samples ⚪ Responsible for proficiency testing of laboratory assays conducted by the College of American Pathologists Laboratory Projects ⚪ Orchestrated the complete redesign of lab workstation computers and electronics for ergonomic and efficient workflow

New York, Ny, Us

⚪ Responsible for the operation of the Sysmex XE-2100 automated hematology analyzer as well as the daily functioning and maintenance of the Clinical Hematology laboratory. ⚪ Responsible for the daily operation and functioning of the Clinical Microbiology laboratory including the operation of the VersaTREK automated microbiology detection system. ⚪ Certified by SAF-T PAK to package and ship biological specimens.

New York, Ny, Us

⚪ Responsible for the operation and maintenance of the CFU-Cell Culture laboratory. ⚪ Skilled at biological cell imaging techniques and manual enumeration of colonies. ⚪ Expert at cell proliferation and cytotoxicity assays. ⚪ Proficient in pathogen detection using molecular techniques, specifically CMV-PCR. Projects and Assignments: ⚪ FDA licensure of ‘Hemacord’: Part of the team responsible for acquiring FDA licensure. ⚪ Conducted to the beta testing of the automated enumeration System using the HRDI technique. ⚪ In charge of the setup, operation, adaptation and implementation of Real Time qPCR towards the detection of cytomegalovirus (CMV) in donor provided Cord blood samples.

Pittsburgh, Pa, Us

⚪ Performed dissection of human lungs in order to extract epithelial and endothelial cells from the inner lining of their airways. Performed primary and secondary cell culture of these cells on a day to day basis.⚪ Performed Cell and Molecular assays on these cultures once completely confluent.

Buffalo, Ny, Us

⚪ Studied the effects of Conjugated Lionoleic Acid on different mast cell lines in vitro.⚪ Assesed changes on cell viability, motility, cell surface protein distribution, etc.

Master Of Business Administration (Mba), Health/Health Care Administration/Management

Master Of Science, Biotechnology

Bachelor Of Technology, Biotechnology

Aissce, Biology, General