Seema Das, Ms, Phd, Ssyb Email and Phone Number
Highly skilled biopharma professional with an exceptional track record in the CDMO industry involved in manufacturing of bulk drug substance and advanced therapy medicinal products (ATMPs). Possesses a unique blend of scientific expertise and exceptional time and people management skills, underscored by outstanding communication abilities, allowing for seamless collaboration and fostering a culture of excellence.I can be reached at +16478195323 or via email seemadas2007@gmail.com. Lets Connect.Research Citations: https://scholar.google.com/citations?user=4UM4K5QAAAAJ&hl=enPersonal Blog: https://gastronomicyogi.wordpress.com/
Cellspark Consulting
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- cellsparkconsulting.com
- Employees:
- 3
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Cellspark ConsultingCanada -
Deliver- Operations SupervisorCcrm Jun 2021 - Jan 2024Mars Discovery District● Managed GMP manufacturing projects for iPSCs and lentivirus.● Executed meticulous review and approval of manufacturing documents (batch records, deviations, SOPs) setting a high industry standard for operational excellence.● Supported regulatory and client audits, assuring impeccable compliance with industry standards and regulatory requirements.● Managed a dynamic and cutting-edge manufacturing operations team (10 direct reports) specializing in the cleanroom activities.● Operational oversight of the following systems: Single Use Stirred Tank Bioreactor-XDR 10, AKTA Flux Tangential Flow Filtration System, VIA-Freeze Controlled-Rate Freezer, Sepax C-Pro Cell Processing System, VIA Thaw, Xuri Cell Expansion System.● Led the implementation of the 5S Lean Methodology, significantly enhancing efficiency and productivity within manufacturing operations.● Supported the team with User Requirements Specification (URS), IQ-OQ, Summary Reports and Requirement Traceability Matrix (RTM).● Fostered an environment of trust, transparency, and collaboration amongst the team and key internal (Quality Control, Quality Assurance, Supply Chain, Facilities and MSAT) and external stakeholders (BlueRock Therapeutics, Notch Therapeutics, The Hospital for Sick Children, Nkarta Inc., panCELLa and Sigilon Therapeutics) laying the groundwork for seamless and open communication that swiftly addressed and resolved impediments. -
Compliance And Deviation Investigations (Dsp, Fme And Automation)Resilience Apr 2019 - Jun 2021Mississauga, Ontario, Canada● Authored deviation reports required for product release or key business needs. ● Recommended and implemented corrective and preventative actions based on the results of the root cause analysis with asset owner collaboration. ● Assisted with review of technical reports (protocols, SOPs) that support cGMP operations. ● Involved in direct interaction with client (Insmed Incorporated) on project specific deviations.● Prepared Quality Metrics and KPI and presented to Senior Management on monthly basis.● Prepared investigation briefing packages for regulatory audits.● Involved in projects that require manufacturing of Bulk Drug Substance, Vaccines (enveloped Virus Like Particle) and Aseptic Fill Finish of the product. -
Staff Clinical Research Associate Ii, Texas Neuroaids Research CenterThe University Of Texas Medical Branch May 2017 - Oct 2018Galveston● Processed human patient samples for isolation of peripheral blood mononuclear cells (PBMCs) and plasma according to study protocol for CNS HIV Antiretroviral Therapy Effects Research CHARTER Study. ● Involved in collection, processing and inventorying of the brain tissues specimens, serum, plasma and PBMCs for the National NeuroAIDS Tissue Consortium at the University of Texas Medical Branch, Galveston. -
Postdoctoral FellowUniversity Of Texas Medical Branch Feb 2016 - Apr 2017Galveston, TexasMolecular Pathogenesis of Ehrlichia Infection. -
Mbi (Mechanobiology Institute)- Research FellowNational University Of Singapore Sep 2014 - Aug 2015SingaporeSalmonella Type III Secretion System. -
Co-Ordinator & Graduate Teaching AssistantUniversity Of Wisconsin Milwaukee Aug 2008 - May 2014BioSci 150 and BioSci 152 (Foundations of Biological Sciences)
Seema Das, Ms, Phd, Ssyb Education Details
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Biotechnology -
Biotechnology
Frequently Asked Questions about Seema Das, Ms, Phd, Ssyb
What company does Seema Das, Ms, Phd, Ssyb work for?
Seema Das, Ms, Phd, Ssyb works for Cellspark Consulting
What is Seema Das, Ms, Phd, Ssyb's role at the current company?
Seema Das, Ms, Phd, Ssyb's current role is Regenerative Medicine- Cell and Gene Therapy | Six Sigma Yellow Belt | People Manager.
What schools did Seema Das, Ms, Phd, Ssyb attend?
Seema Das, Ms, Phd, Ssyb attended University Of Wisconsin-Milwaukee, Bangalore University, Bangalore University.
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