Raj Krish Email & Phone Number

Boston, Ma, Us

United States

• Responsible for providing operational support and services to the lab computing environment including the R&D and QC laboratories.• Skilled in overseeing lab operations, collaborating with cross-functional teams, and optimizing processes. • Implementing new technologies, coordinating, and configuring lab systems to meet scientific workflows and hands on troubleshooting at the lab bench.• Supporting the regulatory compliance of the Quality Control laboratory, • Managed system access, IAM, AD, Endpoint Security, and periodic reviews, fixing gaps after Audit. • Maintaining the regulatory compliant state of GxP laboratory IT systems in a quality management system including SOPs, Configuration Specifications, Change Controls • Supporting analytical instrument validation activities including the development functional and design requirements and execution of test scripts.• Supporting the onboarding of computers related to analytical instrumentation, by creating, tracking, and closing the ticket. • Lead troubleshooting investigations with help from engineering staff with the help of vendor support, such as Empower instrument issues coordinated with Waters.• Partner with the IT Information Security, End User Services, and Operations team to mitigate external/internal threats to computer systems and ensure data integrity.

United States

• Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint.• Responsible for migration of all relevant Tech Ops documentation into the Veeva Quality System• Strong laboratory computer connected devices experience, and maintained good working relationship with Lab Owners, Researchers, IT Teams, and Management. • Clear Understanding of cGxP, cGMP and cGLP process and followed the SOP and Veeva Quality.• Provided Benchtop support for Scientist, Research Associates, Quality Assurance and Quality Control staff along with medical devices connected with lap computers. such as VI Cell, Spectramax, flow cytometers, calorimeters, spectroscopy, PressureMats, qPCRs, Plate Reader, Spectrometers, Malvern Malvern Analytical and Calibrators. • Updated the physical inventory of lab equipment, PC’s, software, and any other information pertinent to the environment using ServiceNow CMDB.• Collaborated with client’s project management team to assure a seamless migration regarding the procurement process. • Documented procedures, policies, and recommended SOP changes via change request. • Maintained daily project related communications with the Win 10 and Lab team. • Participated in daily project meetings.• Listens actively and communicated promptly and effectively with users and the Windows Project management team. Provides timely follow-up. Escalated migration issues to the project manager. • Ability to manage one’s time with minimal supervision to achieve objectives. • Ability to maintain cloud storage drives and as well as provide LIMS Support to better solidify more efficiency for Lab Procedures and Tests.• Provided structural analysis of quality testing.• Overseeing daily operations and quality system implementation• Responsible for developing, organizing, and maintaining records and reports to increase efficiency.

United States

• Coordinated projects, making detailed plans to accomplish goals and directing the integration activities.• Analyze technology, resource needs and market demand, to plan and assess the feasibility of projects.• Conferred with management, production, and marketing staff to discuss project specifications and procedures.• Review and recommend or approve contracts and cost estimates.Consult or negotiate with clients to prepare project specifications.• Setup equipment’s / end-user accounts for New Hires, moves, add, changes as necessary for existing employees.• Responsible for all SW / HW installations, managed network servers and technology tools. Monitor performance and maintain systems according to requirements.• Troubleshoot issues and outages. Ensure security through 24/7 monitoring software, actively participated in date lass prevention. • Audio / Video Support including on-site and Remote. On-Demand, weekend, and holiday support. • Familiarity with Remote Tools such as: TEAMS, Bomgar, VPN, Cisco AnyConnect, ZOOM, Skype, and other 3rd party software. • Win-10 image and Reimage Windows and Mac laptop, Setup iPhone, iPad, and android phone for staff.• Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment.• Lead or provide supporting activities within the quality management system (Infinity)• Provide ownership of assets and utilize Client systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems within ServiceNow.• Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.• Ensure alignment with Client directives and industry guidelines for applications.

United States

• Provided support to Helpdesk (Tier-II, and III,), Desktop Support and Network Infrastructure Teams, who are responsible for Internal and External End-Users. Worked on Active Directory, O365 Admin, Gmail Admin. • Day-to-day work involves all Lab-walks in different buildings, NOC Management, Alarm monitoring, Ticket Management, Routine maintenance.• Responsible for Network Monitoring, and Performance systems includes Setup and upgrades, System Expansions & Microsoft Volume Licensing, New device management, Vendor Support Management, End-User Profile creation and maintenance using Active Directory, Backup Management, and routine maintenance. • Managed Application/OS upgrade/patch pushes SCCM, and Dell Kace1000. Remote access work using SCCM.• Admin role area included Cloud Computing, VMWare/vSphere, Hyper V, SharePoint, SFTP• Worked on MS Office 365 Tenant Management, ADFS & DirSync Support, Domain Management & DNS settings.• User Add, Moves & Changes on AD, Creation of Mailboxes & Security Groups on Exchange Server, SSL, Certificates and License, Vendor Management. • McAfee Anti-Virus Management using policy ePolicy Orchestrator 5.0 and Virus Scan Enterprise 8.8.• Managed and Maintained McAfee IDS/IPS, and DLP • Performing Weekends Symantec Back-up Exec 2010-R3 Management• Monitoring Server Health Using Nagios/LAN Sweeper and Legacy Server-Batch Workflow and Back-up using Symantec Backup Exec and Veeam. • Maintained RAS Server including Juniper, Cisco-VPN, Citrix applications.• Weekly Report/Metrics respect to Ticketing System including but not limited to SLA / SLM and KPI.• Server Management (Win-2003, 2008-R2, 2010-R3, and Win 2012). • Web Sense – Web Filter and Fire Wall.• VOIP Setup – Mitel Communication Center including Audio and Video Configurations

United States

• Supported activities including but not limited to, sample and reference material management, instrumentation, • supported non-GMP manufacturing laboratories at Alnylam, supported critical reagents and consumables inventory, review documentation (procedures, policies) periodically for consistency. • Supported laboratory instrumentation: partner with onsite support team to schedule initial new instrument installations, including IO, OQ and PQ. Ensured instrumentation complies with defined standards. • Maintained accurate inventory of critical reagents and standards.• Supported reference standard management by ensuring and organizing aliquot preparation/ dispensing of reference materials as well as delivery of qualified reference materials in accordance with program needs.• Worked with lab members, and facilities to maintain continuous stock of lab consumables and chemicals.• Worked with team members to support Capex management.• Collaborated with team members to ensure completion of lab operations tasks.• Coordinated shipping of materials (consumables, samples, and standards) to external contract labs, CMOs from Alnylam or between Alnylam sites on as needed basis.• Support Safety inspections of CMC Development laboratories.• Ensured that laboratory standards are followed by performing daily walk-throughs and supporting periodic audits; support remedial measures to improve lab operation. Identify, report, and help team eliminate potential workplace hazards.• Assisted in maintaining the accuracy of asset management database and cataloging of equipment.

United States

• Supervised Desktop Support Infrastructure, Network Support Infrastructure, and 3rd Party Vendor such as Lexmark and HP Printers. Organizing, Managing, and control activities of the IT Help Desk staff ensuring the timely process through which problems are identified, prioritized, and resolved.• As a Lead, worked with members of the Help Desk Senior Staff, Managers, and directly reported to IT-Manager and Director.• Involved in O365 project from start to finish with the help of 3rd party vendor, became O365 Admin.• In-Charge of leading Helpdesk staff, Desktop Support group, and Network group. Weekend and Holidays supervised other groups such as User Security administration, Business and Clinical team. • Managed and tracked Help Desk calls ensuring accuracy and timeliness of information and associated escalation of problem reports. Developed Weekly reports/Metrics on Remedy, Reflection and RT.• Participated in Projects as and when requested by Management such as: Soarian Financials, Chairside Slowness, and WiFi / Wireless conflicts and Virus-Issues related Projects. Involved in product evaluation such as Coradiant, Cardinal, and Nagios. (Ntwk Monitoring and Mgmt Application Tool).• Day-to-Day work involves working on Remedy Ticketing System, Extensive use of Remote application such as PCAnywhere, Dameware Clients (Doctor’s/Physician and Nurses) to resolving complicated desktop and network issues in a timely fashion.• Systems upgrade, patching, and software deployment and administration using SCCM.• Developed and implemented new processes and policies after IT Director approval, Provided many recommendations to management as a when necessary. • Provided back-up coverage for staff on vacation, or on sick leave. Provided Coverage 24/7 working on Saturday, Sunday and on On-Call including company holidays.• Conducted Bi-Weekly Desktop and Network group Meetings.• Travelled as and when required by Management, including local FMC Clinic and Tennessee Nashville.

United States

• Familiarity in Standard Operating Procedures (SOP’s), Master Production Records (MPR’s), Solution Lot Records (SLR’s)individual Batch records (BPR’s) and cGMP as well as CGLP.• Data Trending / Data-Management Using Trackwise, Aegis-Discoverant(Primr), Excel, Access db.• Manipulated Data for Research on products such as Avonex, VLA1, LtBeta and Zevalin. • Captured data, information related to Batch Records, and SLRs for all process (Clinical and Commercial) and entered the same in various Databases such as Discoverant, and MS-Excel with hundred percent accuracy in a timely manner from Cell Culture and Purification Plants in diff sites for products such as Avonex, LtBeta, VLA-1, and Zevalin.• Took “On the job training” such as 1. SOP:25a.3, 2. Corp 007- Regulatory Agency Inspections, 3. EHS-Hazardous Waste Refresher, 4. EHS-Incident Investigations, 5. Incident Spill Response, 6. Basic Biosafety, 7. Bloodborne Pathogens, 8. Multi-Product Manufacturing and 9. Various IT-Related training on MS-Excel prog.• Took in-charge of Changing Chart Recorder on weekly basis for Cell-Banking Incubators, Cold-Room freezers and MTS-Incubators (RM233), and reviewed the same. • Co-Ordinate between BPU-Manufacturing and QA departments for Data Management• Involved in Data-Research, Small Projects for various department Managers and developed and submitted the same in MS-Excel as and when required by them. • Developed Excel Template from scratch for the new product Zevalin, and for Data Entry Status. • Scanned product chromatography charts into validated systems on the network.• Lab and Plant exposure including Bioreactor (100L, 750L and 2000L) and Train 1-2-3 and 4-5.• Performed and Took ownership of new clinical and commercial process data’s analysis in the spreadsheet and in Ageis database. • Used Clinical Trail Management Systems (CTMS) EDE application (Electronic Data Capture) to create CRF (electronic case report forms) for drugs / device trial.

United States

• Managed any devices attached to computer, including contacting the vendor, configuration, systems update and upgrades.• Performed Tissue Culture Techniques / involved in Clinical Research and Design• Involved in Proteins Purification, did twelve-hour shift.• Involved in various manufacturing stages in Protein Purification Plant • Updated SOP documents for Protein Purification department• Participated and co-coordinated in all kinds of clinical and commercial production.

Post Graduate Bio-Medical Laboratory And Clinical Sciences, Biomedical/Medical Engineering, 3.5

Bachelor Of Science - Bs, Physics, Chemistry, Botany And Zoology, 3.5

Bachelor'S Degree, Biomedical/Medical Engineering

Focus on Chemistry - Biology- Zoology - Physics