Senior Manager

Hetal Brahmbhatt

St. Augustine, FL. 904-***-****

******@*****.***

EDUCATION & CERTIFICATION

Maxwell Leadership Certification Mar 2024

PhD in Biochemistry and Biomedical Sciences Sep 2010 - Mar 2016 MSc in Biochemistry and Biomedical Sciences (direct transfer to PhD) Sep 2008 - Aug 2010 BSc in Biochemistry (specialization in Molecular Biology) Sep 2004 - Apr 2008 McMaster University, Hamilton, ON

EXPERIENCE

Senior Manager, Science and Technology Team Dec 2021 - Present Principal Scientist, Science and Technology Team Jun 2019 - Dec 2021 Thermo Fisher Scientific, Alachua, FL

Develop standardized platforms and technologies suitable for the cGMP manufacturing of viral vectors used in cell and gene therapies

Collaborate with product development, process development, quality, GMP and regulatory teams within the company to ensure manufacturing platform design and components are in compliance with FDA and cGMP requirements

Design detailed process and product development studies (upstream and downstream) ensuring that scale-up and facility requirements are maintained

Provide technical insight and implement troubleshooting approaches as needed

Supervise upstream and downstream laboratory personnel to ensure successful execution and completion of planned experiments

Oversee training of all upstream and downstream lab personnel and ensure that operations are conducted in compliance with safety standards Principal Scientist, Downstream Process Development Jul 2018 – Jun 2019 Brammer Bio, Alachua, FL

Responsible for developing, establishing and executing downstream purification processes for cGMP manufacturing of viral vectors for several clients

Manage downstream laboratory, personnel and resources in collaboration with team leads to ensure efficient execution of operations

Proactively identify and escalate key risks and issues to manufacturing leads and leadership team and implement necessary troubleshooting actions for resolution

Design and implement training initiatives for the downstream team

Served as the technical project lead for one client project by o Working closely with Project Managers, Operational Leads and Subject Matter Experts to ensure completion of client projects in a timely manner o Communicating change order requirements to improve process design o Overseeing all technical areas (upstream, downstream and analytics) from the process development stage to transfer to manufacturing sciences o Ensuring processes are compliant with company and regulatory standards o Coordinating and providing insight into process risk assessments, equipment gap analysis, and key project stage gate decisions

Senior Scientist, Downstream Process Development May 2017- Jul 2018 Brammer Bio, Alachua, FL

Served as the downstream project lead for several client projects to ensure downstream purification processes are suitable for cGMP manufacturing

Conducted technical review of incoming purification processes to identify process risks and gaps and collaborated with the manufacturing team to implement mitigation strategy

Prepared purification process development or establishment plans and sourced appropriate reagents, materials, and equipment

Documented procedures and protocols for execution of downstream operations while ensuring scale-up principles are met

Assisted in the execution and optimization of downstream purification processes such as chromatography, tangential flow filtration, ultracentrifugation

Collected, organized, and analyzed purification data and communicated findings through summary reports and presentations

Postdoctoral fellow Apr 2016 - Aug 2016

Graduate student researcher Sep 2008 - Mar 2016

Laboratory of Dr. David Andrews, McMaster University, Hamilton, ON and Sunnybrook Research Institute, Toronto, ON

Planned and executed 3 research projects on the discovery and characterization of small molecules for use in mechanistic studies and as cancer therapeutics

Conducted mechanism of action studies using biochemical and biophysical techniques

Established assays to identify cell death blocks in various cancer cell lines and evaluate the use of small molecules as treatment approaches for these cancers

Communicated research progress weekly to highlight key findings and address areas for troubleshooting and optimization

Presented scientific research data in written and oral formats (reports and presentations) at laboratory meetings, committee meetings, departmental seminars

Routinely conducted literature searches to identify key findings in the field and re- evaluated research projects accordingly

Assisted laboratory safety representatives to ensure laboratory standards are being met

Key achievements: 6 scholarship awards, 4 scientific publications, and selection as a presenter in 8 scientific conferences and workshops Teaching Assistant

Cellular Biochemistry Jan - Apr, 2010 - 2012

Nucleic acid structure and function Jan 2009 - Apr 2009 Introductory Chemistry Sep 2007 - Apr 2008

McMaster University, Hamilton, ON

Guided students in formulating research questions, critically evaluating current research to identify solutions/approaches, and effectively presenting findings

Facilitated group discussions to promote the exchange of ideas and findings

Discussed student progress by providing descriptive feedback on assignments

Organized and managed the course content by updating the course curriculum website

Assisted with the preparation and evaluation of questions for tests and exams and maintained records of student grades

Supervised and trained students in instrument use, techniques, reagent preparation, and general laboratory safety

Highlighted concepts introduced in class by teaching students to record, analyze data, and communicate scientific findings through lab reports

Assisted students in understanding course content on a one-on-one basis as required

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