Gokul Kalur, Ph.D., Cqa Email and Phone Number
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Ph.D. Chemical Engineer with over 25 years of engineering experience spanning across small molecule and biologics pharmaceutical ingredients, medical devices, and high-performance polymers. Proven leader in managing projects and personnel, with a strong track record of guiding cross-functional teams in process development, scale-up, and validation of technical and business solutions. Achievements include process development and optimization, efficiency improvement, and significant cost savings. Skilled in building strong relationships with key stakeholders and across organizational levels to negotiate and build consensus. Excellent communication and presentation skillsCore competencies: process development • process engineering • process & equipment validation • small scale and large-scale manufacturing • continuous improvement • variable cost productivity • budget and financial planning • strategy & business planning • maintenance & calibration • people leadership • communication
Lachman Consultant Services
View- Website:
- lachmanconsultants.com
- Employees:
- 195
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Lachman Consultant ServicesSan Ramon, Ca, Us
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Senior Associate, ComplianceLachman Consultant Services Mar 2024 - PresentWestbury, Ny, UsAs a member of the Lachman team, I offer compliance, and science & technology services to clients around the world
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Senior Engineering Manager, Laboratory Equipment ServicesGenentech Feb 2020 - Jul 2023South San Francisco, California, UsLed teams to maintain more than 25,000 instruments in Research and Early Development organization- Core member of the team that launched laboratory equipment management (LEM) program to save over million dollars annually by increasing traceability and cutting wastes- Led the work stream for asset tracking and master data of instruments within the LEM program- Developed the data analytics capability within the facilities, operations and maintenance organization- Applied reliability tools for increasing the availability of equipment and the productivity of the maintenance teams- Optimized the calibration frequency of instruments leveraging reliability tools- Supported teams to bring in-house the capability to maintain complex instruments including automated robots resulting in over million dollars of savings in vendor service contracts -
Manager, Instrumentation And CalibrationGenentech Jul 2018 - Feb 2020South San Francisco, California, UsSupervised a team of instrument technicians in the facilities and engineering organization to ensure calibration compliance of instrumentation used in the production plant at South San Francisco site- Developed and implemented a plan to execute overdue calibrations- Created a sustainable process to schedule maintenance and calibrations of production equipment and instrumentation thereby improving compliance and reliability- Supported my team to keep their morale, enthusiasm and motivation, which resulted in exemplary performance by the team. Shared the best practices with other teams to improve the organization's performance
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Sr. Engineer, Drug Substance Process EngineeringGenentech Jun 2016 - Jul 2018South San Francisco, California, UsBIOLOGICS DOWNSTREAM PROCESSING:- Process champion for biologics drug substance manufacture with annual sale of approx. $400 million resolving any production unplanned events and monitoring the manufacturing process - Trained manufacturing operators on the updated process for each campaign- Developed and implemented innovative process solutions to solve persistent production problems - Authored APQR chapters for commercial biologic products- Co-led the development of huddle boards to enable operational excellence in the drug substance process engineering group- Led teams to execute projects for cost productivity and process improvement- Successfully led the documentation of microbial contamination risks of various operations into Stature Risk Management software
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Project Engineer, Shop Floor Management (Gig)Roche Diagnostics Aug 2019 - Nov 2019Middle East, OoDeployed shop floor management tools including visual boards that improved the adherence to schedule and factory adherence to >97% (vs. target of 95%)- Supported the Operations and Quality Control teams to develop KPIs. - Coached the teams to ask probing questions that lead to accountability and solution to any issues. - Enabled the culture of empowerment for actively solving day to day issues at the huddle boards -
Assistant Process Manager, Api & Intermediate ManufacturingRoche Apr 2013 - Jun 2016Switzerland 🇨🇭 , ChMANAGEMENT EXPERIENCE:- Led manufacturing teams, participated in resource planning, recruitment, mentoring, performance evaluation, and development plans- Created operational processes and strategies to meet supply chain targets SMALL MOLECULE API & INTERMEDIATES MANUFACTURING:- Direct plant shop floor supervision of commercial production for API with annual sales of approx. $500 million - Improved productivity in the plant resulting in 8% increase in yield per batch - Led new equipment validation and cleaning validation of the plant- Supported the stability study requirements for APIsENGINEERING, PROJECT MANAGEMENT & REGULATORY EXPERIENCE- Led the team for pre-approval inspection (PAI) preparation resulting in successful FDA audit - Authored APQR chapters for commercial products in small molecules- Participated in FMEA and risk analysis for the manufacturing plant and documented the risk management strategy in Stature -
Advanced Project EngineerGe Healthcare Feb 2009 - Apr 2013Chicago, UsProvided support to manufacturing operations. Owned and led projects for variable cost productivity, improved efficiency and for development of new technology and products.- Selected vendor for cost effective and improved quality resin for MRI magnet manufacture resulting in savings of about a million dollars annually- Executed lean six-sigma projects, performed FMEA, participated in budgeting- Trained on design for reliability (DfR), obtained reliability practitioner certification and executed several projects leveraging the reliability tools -
Principal Scientist/EngineerIrix Pharmaceuticals Jan 2004 - Feb 2009Us- Led teams of scientists, research associates and operators in a multi-tasking environment. - Successfully managed multiple research and manufacturing projects including planning schedule, budget and resources- Developed and scaled-up processes; led tech-transfer to cGMP production- Collaborated in boundary less manner with other departments (QC, QA and EHS) to meet production targets- Worked hands-on to evaluate, improve and optimize processes for the manufacture of new active pharmaceutical ingredients (APIs) and intermediates under current good manufacturing practices (cGMP)- Carried out hazard evaluation using reaction calorimetry to aid scale up operations- Authored accurate batch operating procedures for the multi-step cGMP API processes - Technical expert representing IRIX to the customers -
Post Doctoral ResearcherUniversity Of Maryland May 2002 - Jan 2004College Park, Md, Us• Studied and controlled the self-assembly of aqueous complex fluids- Authored five peer reviewed journal publications and presented at six conferences• Managed daily operations of the laboratory and mentored students• Hands on experience in operation of, data analysis and interpretation from ion exchange chromatography, dynamic and steady state rheometers, small angle neutron scattering, and dynamic light scattering -
Process EngineerGe India Technology Center Nov 1999 - Apr 2002Boston, Ma, Us• Applying six sigma methodology, developed a rigorous process model of monomer plant in Aspen Plus to guide experimentation and provide data for conceptual engineering package for new Ultem plant -
Production Manager And Manager - R&DAbr Organics Limited Jan 1995 - Nov 1999• Managed production and led operations team to ensure uninterrupted production of multiple grades of phenolic and polyimide resins in a three-shift operation. - Interacted with government officials to comply with requirements of regulatory bodies - Developed budgets, planned and monitored inventories to aid working capital management and profit & loss account• Led a team of scientists to develop different grades of polyimide and phenolic resins, and their applications. - Evaluated different strategies, optimized and scaled up polymerization processes of phenolic and polyamide resins for commercial production
Gokul Kalur, Ph.D., Cqa Skills
Gokul Kalur, Ph.D., Cqa Education Details
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Institute Of Chemical TechnologyChemical Engineering
Frequently Asked Questions about Gokul Kalur, Ph.D., Cqa
What company does Gokul Kalur, Ph.D., Cqa work for?
Gokul Kalur, Ph.D., Cqa works for Lachman Consultant Services
What is Gokul Kalur, Ph.D., Cqa's role at the current company?
Gokul Kalur, Ph.D., Cqa's current role is Passionate and experienced professional specializing in process engineering and operations in the pharmaceuticals industry offering compliance, and science & technology services to clients around the world.
What is Gokul Kalur, Ph.D., Cqa's email address?
Gokul Kalur, Ph.D., Cqa's email address is ka****@****ene.com
What schools did Gokul Kalur, Ph.D., Cqa attend?
Gokul Kalur, Ph.D., Cqa attended Institute Of Chemical Technology.
What are some of Gokul Kalur, Ph.D., Cqa's interests?
Gokul Kalur, Ph.D., Cqa has interest in Running.
What skills is Gokul Kalur, Ph.D., Cqa known for?
Gokul Kalur, Ph.D., Cqa has skills like Process Simulation, Six Sigma, Engineering, Chemical Engineering, Validation, Dmaic, Chemistry, Chromatography.
Who are Gokul Kalur, Ph.D., Cqa's colleagues?
Gokul Kalur, Ph.D., Cqa's colleagues are Eric Richmond, Kelly Rainford, John Goetz, Karen T., Dannie Rowland, Sherry Faron, Jessica Soderberg.
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