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Industry Experienced Team Members, Innovative GenAI Platform to expedite R&D, Clinical, CMC, Labs, Quality, Compliance and Infrastructure support processes. Building a Bio Ecosystem to expedite drug discovery, clinical development phases, manufacturing and commercializing - Patients Are Waiting.
From discovery to products benefitting Patients in Need. Ensuring robust data management throughout life cycle in R&D, Clinical Trials, Commercial Manufacturing, supporting Infrastructure. Focusing on data sources and verifying for data integrity to enable submissions and inspection readiness.
Automated flags to remove compliance and security gaps, AI based process improvements in Clinical Stage, CMC Manufacturing, Labs, Quality and IT landscape end-to-end time and cost reductions. Competitive Advantage.
Mani is the Founder and CEO of BayGeneBio LLC.
He has 35 Years of experiences in high-tech and biopharma, cell gene therapy, medical device working for global corporations like Gilead Sciences, Samsung BioLogics, Roche/Genentech, Amgen, Eli Lilly, GE Health Care, IBM, and State Govt. of NC.
Mani is driven by serving Patients, has excell
Mani is the Founder and CEO of BayGeneBio LLC.
He has 35 Years of experiences in high-tech and biopharma, cell gene therapy, medical device working for global corporations like Gilead Sciences, Samsung BioLogics, Roche/Genentech, Amgen, Eli Lilly, GE Health Care, IBM, and State Govt. of NC.
Mani is driven by serving Patients, has excellent people and collaboration skills with vision to make a difference. He has deep expertise in FDA Compliance, Quality and IT across all functions. He has added value by setting up GxP IT Systems, large CSV/CQV implementations, Quality & Compliance program setup and operations with automating workflows with GenAI based Quality Engine Application, Data Integrity Program management to plan, execute and remediate identified gaps.
Mani has BS in Electrical Engineering from University of Kentucky, Lexington, KY.
Ron is a biopharma industry veteran with 40 years of experience in Quality Management and shaping Manufacturing operations for excellence and continuous improvement. He has held many executive management roles including senior vice president (SVP) at Samsung Biologics and Alvotech. His leadership skills have helped various virtual, small
Ron is a biopharma industry veteran with 40 years of experience in Quality Management and shaping Manufacturing operations for excellence and continuous improvement. He has held many executive management roles including senior vice president (SVP) at Samsung Biologics and Alvotech. His leadership skills have helped various virtual, small, mid-sized and large companies in the fields of biologics, vaccines, cell & gene therapy and biosimilars.
A collaborative, results oriented and accomplished BioPharma professional with an expansive skill set and tenure of success with large Biotech and Cell/Gene Therapy companies. Someone who has started from the ground floor and worked to the Sr. Leadership level, building, coaching, and leading teams. With technical experience in all
A collaborative, results oriented and accomplished BioPharma professional with an expansive skill set and tenure of success with large Biotech and Cell/Gene Therapy companies. Someone who has started from the ground floor and worked to the Sr. Leadership level, building, coaching, and leading teams. With technical experience in all facets of the Manufacturing and Quality processes and expertise in Seed Train and Drug Product, there is little that has not been tapped in to.
At BayGeneBio LLC, we have assembled a team of talented and dedicated professionals who are passionate about improving healthcare through biotechnology. Our team includes scientists, researchers, engineers, and business professionals, all of whom bring unique skills and perspectives to our work.
Innovation is at the heart of what we do at BayGeneBio LLC. We are constantly pushing the boundaries of biotechnology and developing new products and therapies that have the potential to transform healthcare. Our focus on innovation has earned us a reputation as a leader in the biotech industry. Use of GenAI in all functions.
We are proud of the impact that our biotech products and therapies have had on patient care. Our products have been used to diagnose and treat a wide range of health conditions, from cancer to infectious diseases. We are committed to continuing to develop innovative solutions that improve patient outcomes.
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