Maulik Patel
Associate Director, Project Management at ElevateBio- Claim this Profile
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English Full professional proficiency
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Hindi Native or bilingual proficiency
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Gujarati Native or bilingual proficiency
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Bio
Ravi Samavedam
Maulik worked at Azzur initially as a consultant support quality/validation and facility start up efforts. His work at client sites was always appreciated in the form of extensions and perhaps offers! He transitioned to the Cleanrooms on Demand business where he excelled initially as a client project manager and soon moved up to become the right hand person for the site Sr. Director, leading both the internal operations and client operations groups. His strengths include self motivation and ability to "figure it out" with minimal supervision. His experience prior to Azzur at a CMO combined with his experience at CoD, as well his consulting stints, have made his a well rounded biotech professional with exposure to a variety of process, products, facilities and the issues that arise in such scenarios. He is going to be an asset to any organization willing to give him the opportunity to grow.
Marie Allen-Hadge
Maulik and I shared a very collaborative working relationship while we were together at Vedanta BioSciences. His commitment to excellence, strong work ethic and enthusiasm for our work highly contributed to a healthy and dynamic team environment. No job was ever too big or too small. He is incredibly experienced with start-up organizations through product commercialization. He is well organized, a self-starter, and extremely dependable. I would highly recommend him and consider him as one of the best validation engineers/leaders that I have worked with.
Ravi Samavedam
Maulik worked at Azzur initially as a consultant support quality/validation and facility start up efforts. His work at client sites was always appreciated in the form of extensions and perhaps offers! He transitioned to the Cleanrooms on Demand business where he excelled initially as a client project manager and soon moved up to become the right hand person for the site Sr. Director, leading both the internal operations and client operations groups. His strengths include self motivation and ability to "figure it out" with minimal supervision. His experience prior to Azzur at a CMO combined with his experience at CoD, as well his consulting stints, have made his a well rounded biotech professional with exposure to a variety of process, products, facilities and the issues that arise in such scenarios. He is going to be an asset to any organization willing to give him the opportunity to grow.
Marie Allen-Hadge
Maulik and I shared a very collaborative working relationship while we were together at Vedanta BioSciences. His commitment to excellence, strong work ethic and enthusiasm for our work highly contributed to a healthy and dynamic team environment. No job was ever too big or too small. He is incredibly experienced with start-up organizations through product commercialization. He is well organized, a self-starter, and extremely dependable. I would highly recommend him and consider him as one of the best validation engineers/leaders that I have worked with.
Ravi Samavedam
Maulik worked at Azzur initially as a consultant support quality/validation and facility start up efforts. His work at client sites was always appreciated in the form of extensions and perhaps offers! He transitioned to the Cleanrooms on Demand business where he excelled initially as a client project manager and soon moved up to become the right hand person for the site Sr. Director, leading both the internal operations and client operations groups. His strengths include self motivation and ability to "figure it out" with minimal supervision. His experience prior to Azzur at a CMO combined with his experience at CoD, as well his consulting stints, have made his a well rounded biotech professional with exposure to a variety of process, products, facilities and the issues that arise in such scenarios. He is going to be an asset to any organization willing to give him the opportunity to grow.
Marie Allen-Hadge
Maulik and I shared a very collaborative working relationship while we were together at Vedanta BioSciences. His commitment to excellence, strong work ethic and enthusiasm for our work highly contributed to a healthy and dynamic team environment. No job was ever too big or too small. He is incredibly experienced with start-up organizations through product commercialization. He is well organized, a self-starter, and extremely dependable. I would highly recommend him and consider him as one of the best validation engineers/leaders that I have worked with.
Ravi Samavedam
Maulik worked at Azzur initially as a consultant support quality/validation and facility start up efforts. His work at client sites was always appreciated in the form of extensions and perhaps offers! He transitioned to the Cleanrooms on Demand business where he excelled initially as a client project manager and soon moved up to become the right hand person for the site Sr. Director, leading both the internal operations and client operations groups. His strengths include self motivation and ability to "figure it out" with minimal supervision. His experience prior to Azzur at a CMO combined with his experience at CoD, as well his consulting stints, have made his a well rounded biotech professional with exposure to a variety of process, products, facilities and the issues that arise in such scenarios. He is going to be an asset to any organization willing to give him the opportunity to grow.
Marie Allen-Hadge
Maulik and I shared a very collaborative working relationship while we were together at Vedanta BioSciences. His commitment to excellence, strong work ethic and enthusiasm for our work highly contributed to a healthy and dynamic team environment. No job was ever too big or too small. He is incredibly experienced with start-up organizations through product commercialization. He is well organized, a self-starter, and extremely dependable. I would highly recommend him and consider him as one of the best validation engineers/leaders that I have worked with.
Credentials
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Verified International Academic Qualifications
World Education ServicesJun, 2020- Nov, 2024
Experience
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ElevateBio
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United States
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Biotechnology Research
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200 - 300 Employee
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Associate Director, Project Management
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Mar 2022 - Present
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Azzur Group
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United States
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Senior Manager, ACoD Operations at Waltham
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Nov 2020 - Mar 2022
Effectively execute the business of Operations department that includes Engineering, Project Management, Facilities and Materials Management teams.Provide engineering leadership for the technology transfer efforts to implement new products at Azzur’s facility.Perform technical review of documents such as Tech Transfer Plans, Gap Analysis, Validation Master Plan, Site Master File, material testing records, EM summary reports. Provide technical assessment on deviations, CAPA, and change controls.Provide business related data to global leadership team such as headcount, hiring, CapEx, OpEx, and external spend and organize the data into trackable metrics including the creation of presentations & reports.Provide effective solutions to client specific issues and drive continuous improvement efforts.Generate, update, and approve business operations documents such as Statement of Work (SOW), Change Orders (CO), Master Service Agreement (MSA).Efficiently manage onsite activities including supply chain, material and equipment procurement, raw material testing and release, manufacturing campaigns, batch production schedules, product banking, domestic and international shipping.Generate capital expansion, renovation and demolition plans for cleanrooms that includes designing floor plans, personnel and material flow, specifying systems and equipment.
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Project Manager
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Aug 2019 - Nov 2020
*Partnered closely with CMC functional areas to develop and maintained integrated project plans toidentify and communicate interdependencies as well as critical path activities for the project.*Effectively communicated with team members, senior leaders and key stakeholders on the status,objectives, critical paths, risks, and mitigation plans associated with projects.*Efficiently managed internal and external resources to deliver the project deliverables on time andwithin budget.*Supported the development of SOW for partnered programs and track deliverables for finance toenable invoicing.*Utilized the project management tools such as MS project, Harvest, Salesforce, Smartsheets foreffective project control.*Lead and performance manage Project Engineers
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Process Engineer II
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Jan 2018 - Aug 2019
*Generate and execute FAT, SAT, IQ, OQ, PQ for equipment, systems, utilities and processes for qualification/verification and/or re-qualification/re-verification.* Generate user requirement specifications (URS), functional requirement specifications (FRS) & Detail Design Specifications (DDS)*Develop Validation Plans for validation projects, qualification and validation of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes.*Resolve deviations/ discrepancies, review and analyze study data, write summary reports.*Initiate and perform investigations to close out deviations. Ensure corrective actions are resolved in a timely manner.*Generate & Update P&IDs*Develop CIP and SIP strategies and execute qualification protocols
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Axcellerate Pharma
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United States
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Pharmaceutical Manufacturing
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Process/ Project Engineer
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Sep 2015 - Jan 2018
* Review, update and generate process and utility P&IDs. * Prepare and maintain validation master plan and preventive maintenance program to keep all systems and equipment compliant with cGMP Standards. * Generated IQ, OQ and PQ protocols for Facility, Utility, System and Equipment which included fermenter, bioreactor, buffer tanks, autoclave, aseptic filling machine, transfer panel, gas distribution systems, WFI, CS, PW, Classified Rooms and AHUs. * Generate Renovation and Demolition Plans for Sterile Operations Suite that includes floor plans of clean rooms, foot prints of process equipment, personnel flow and material flow. * Generate URS for process equipment such as Aseptic Filler, Autoclave, Depyrogenation Oven, Lyophilizer and Stoppering machine. * Prepare Demolition and Renovation Plan for existing Biologics Suite which includes upgradation in current upstream processing capacity, installing new 1000L fermenter, centrifuge and chromatography skid for Phase I & Phase II products. * Participate in Engineering Procurement that includes generating RFPs, Spec Sheets, reviewing vendor quotations, performing cost calculation and sorting the bids * Prepared Gantt Charts & manage projects that include site renovation, utilities modification, equipment procurement, cost estimation, budgeting, scale up strategy development, CIP strategy, commissioning and qualification. * Generate and update operations and manufacturing SOPs. * Coordinate with multi-disciplinary Axcellerate Pharma staff to achieve the goals of the ongoing projects. * Participate in safety processes and meetings as applicable. Potent Compound Handling: Specify and make recommendations with regards to handling of lyophilization potent compounds.
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Novo Nordisk
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Denmark
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Pharmaceutical Manufacturing
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700 & Above Employee
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Validation Project Engineer (Panorama Consulting)
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Jan 2016 - Jan 2017
* Generated and executed IQ, OQ and PQ of facility, utility, system and equipment as part of periodic validation program. * Assisted in assessment of sampling plans and determined flow paths and sampling points which need to be tested in order to meet validation requirements. * Reviewed and walked down P&IDs to identify the modifications before protocol generation and execution. * Prepared Turn Over Packages of Buffer Tanks, WFI, CS and AHUs. * Generated test forms and scripts in accordance with SOPs and Work Instructions.
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TeraRecon, Inc.
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United States
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Software Development
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100 - 200 Employee
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Biomedical Engineer (while pursuing MS )
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Dec 2014 - Dec 2015
* Analyze and resolve complex issue associated with high –end real time diagnostic 3D workstations and 3D streaming service. * Test and Investigate problems related to real-time volume rendering hardware engines. * Maintain a detailed log of description of the issues and remedial actions taken in resolution of them. * Generate a report and follow-up with engineering team on issues identified as bugs in the software. * Design data workflow models for customers prior to installation of the high-end 3D systems employed for medical diagnostic use.
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Soma Tech Intl
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Enginee-I
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Jun 2012 - Jun 2013
Performed field studies, tests, literature survey, designed and implemented a product to provide “cost- efficient” solution for IABP’s power supply unit issues working in a R&D team of Soma Technology. Performed field studies, tests, literature survey, designed and implemented a product to provide “cost- efficient” solution for IABP’s power supply unit issues working in a R&D team of Soma Technology.
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Education
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University of Massachusetts Lowell
Master of Science (M.S.), Biomedical/Medical Engineering -
Gujarat Technological University, Ahmedbabd
Bachelor's of Engineering In Biomedical Engineering, Biomedical/Medical Engineering
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