Priya Shah, PMP®
Project Manager at Batavia Biosciences- Claim this Profile
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English Full professional proficiency
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Gujarati Native or bilingual proficiency
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Hindi Native or bilingual proficiency
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Spanish Elementary proficiency
Topline Score
Bio
Credentials
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Project Management Professional (PMP)
Project Management InstituteOct, 2022- Nov, 2024
Experience
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Batavia Biosciences
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Netherlands
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Biotechnology
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100 - 200 Employee
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Project Manager
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May 2023 - Present
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Mizuho OSI
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United States
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Medical Device
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200 - 300 Employee
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Project Manager (Remote)
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Mar 2020 - May 2023
• Successfully managed an engineering project from Design Phase to Closure Phase, with 5 year projected net sales of $6.3M. o Created project plan and waterfall schedule, monitored and reported project risks, coordinated with suppliers for material needs, led daily scrum meetings, identified blockers, and helped resolve issues cross functionally o Managed all documentation for Design History File (DHF) per Design Control Procedure • Managed cost of a major capital engineering project by establishing a tool to keep track of project spending, volume estimates, and value engineering cost • Managed tracking of all parts, long lead items, and BOMs by coordinating with Engineers and Supply Chain throughout the development phase • Streamlined project process by developing a shared master file and organizing all project information in there (project scope, deliverables, roles and responsibilities, cost, lessons learned, etc.) o Allowed for easy visibility and accessibility of project information by team and key stakeholders o Implemented across the PM group for all future projects • Established a tool for tracking resource activities for entire R&D department • Ensured product met quality requirements by coordinating testing with QC; corrected Non-Conformance Reports (NCRs) in timely manner • Managed project teams to comply with medical device design control requirements of FDA and ISO 13485 • Proactively planned for and mitigated project risks before they arose; addressed corrective actions • Negotiated the use of resources, budget, schedule, and prevented scope creep • Reported weekly project status to VP and Directors of R&D • Produced reports and presented monthly project status to CEO and cross functional department heads (Quality, Regulatory, NPI, Supply Chain, MFG, etc.) • Effectively conveyed vision, ideas, goals, and issues via verbal and written communications Show less
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Associate Scientist - MSAT
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Oct 2018 - Feb 2020
• Executed Streptococcus pneumoniae Upstream fermentation process at 2L and 10L scale-down model of Prevnar vaccine for the Manufacturing Science and Technology (MSAT) department• Planned and managed lab experiments, schedule, resources, and dependencies in advance to meet deadlines• Successfully designed and performed complex studies to test multiple conditions; managed experiments from planning, design, and execution to closure phase• Improved process by automating bioreactor parameters and conditions to reduce human error• Proactively identified and escalated project risks and ensured proper mitigation plans• Effectively led cross-functional team projects in collaboration with manufacturing• Facilitated daily Visual Management board meetings to update team on project status, safety, and trainings• Analyzed experimental data and results; presented weekly on project status to the team and key stakeholders• Provided subject matter expertise (SME) for commercial processes and manufacturing investigations• Trained new hires on various steps in the fermentation process • Maintained GDP via excellent documentation keeping on experiment timelines, operations, and results• Environment Health and Safety (EH&S) Representative for the MSAT group Show less
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Associate Scientist - MSAT
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Mar 2017 - Oct 2018
• Reduced human error by developing a Job Aid and Operating Procedures to standardize lab activities • Contributed to the development of second-generation FIX, mammalian cell culture, and upstream process through small scale process characterization experiments• Ensured quality by systematically monitoring temperature, cell viability, cell density, pH, and other parameters from cell culture samples• Cross-trained in downstream purification processes and gained experience on the various process parameters• Responsible for sample management and freezer inventory Show less
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Research Assistant
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Oct 2016 - Mar 2017
• In charge of formulating media and buffer solutions
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The Academy at Rutgers for Girls in Engineering and Technology (TARGET)
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Rutgers University
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Program Manager - Engineering Summer Camp
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Jun 2014 - Aug 2014
• Program manager of The Academy at Rutgers for Girls in Engineering & Technology (TARGET) program • Planned creative and interactive engineering-focused activities for middle school to high school aged girls • Trained other counselors and delegated tasks for organizing hands-on activities • Created timelines, schedules, and informative presentations for various projects throughout the summer • Ensured supplies were purchased on time for the planned activities • Improved and enhanced student understanding of various engineering disciplines and problem-solving skills via hand-on projects Show less
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Education
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Rutgers University-New Brunswick
Bachelor’s Degree, Biomedical/Medical Engineering