Summary
Overview
Work History
Education
Skills
Publications
Awards
References
Certification
Additional Information
Languages
Quote
Timeline
Generic

MEGHA MAHABOLE

Gainesville,FL

Summary

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Being in the Life Sciences industry for over 11 years helped gain excellent hands on experience with lab skills and develop soft skills such as leadership, fast learning aptitude to handle tasks with accuracy and maintain the quality aspects following GMP. Have experience in the area of Biologics, HCT/P grade medical device and in the field of gene therapy. Proficient in data integrity, document control and process improvement.

Overview

11
11
years of professional experience
1
1
Certification

Work History

QA Compliance Specialist II

Lacerta Therapeutics
03.2023 - 10.2023
  • Wrote URS, Risk Assessment, System Impact Assessment related to GMP facility and equipment
  • Wrote SOPs related to Warehouse management, Material control, Supplier Qualification, Training program, Document Change Control, Deviations, NCR, CAPA and OOS
  • Evaluated Vendors for Inventory Management System and eQMS system, compare and present to higher management
  • Participated in new GMP facility commissioning plan and deliverables lists
  • Participated in GMP Facility walkthrough and checking for construction issues/anomalies, flagged and reported to contractors for remediation
  • Monitoring and improving Quality System by evaluating supporting documentation to ensure compliance to cGMP, industry standards and other applicable regulations
  • Coordinated with various teams such as gene therapy manufacturing facilities, process development, and quality assurance to align SOPs/MBRs/Forms/WIs
  • Responsible for review of manufacturing batch records, Quality Control records, systems/facility use/monitoring/maintenance records to ensure compliance with SOPs
  • Responsible for reviewing final reports and other documentation related to technology transfer
  • Maintaining QA records per document control procedures.
  • Performed quality reviews to uncover workflow and communication issues.

Senior Scientist

Lacerta Therapeutics
07.2022 - 03.2023
  • Performed lysate preparation, purification and tittering assays for Baculovirus expression vectors (BEVs) and performed infection in insect cells to produce recombinant Adeno associated virus (AAV) with gene of interest
  • Develop CRISPR/dCas block method to restrict the packaging of DNA to gene of interest in rAAV
  • Performed insect cell stability studies
  • Introduced good documentation practices (GDP) to rAAV preparation and analytical testing
  • Formalized process development and analytical testing procedures and batch records for readiness in relation to Technology Transfer to collaborators.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.
  • Conducted experiments in laboratory environment for product development purposes.
  • Conducted document review, organization and quality control of data acquisition to draw relevant conclusions and direct research activities.

Lab Manager

BioTissue, Inc.
05.2021 - 07.2022
  • Coordinate and maintain lab functions as required
  • Manage 4 direct reports by discussing and assigning tasks, training, performing assessments
  • Oversee Supply Inventory Management
  • Ensure Equipment logbook completion and review
  • Perform Vendor Qualification for purchase of Equipment/Supplies
  • Approve Purchase Orders.
  • Set and oversaw quality assurance guidelines for laboratory work.
  • Interviewed, hired and trained lab technicians to perform experiments and analyze results.
  • Resolved issues with product development from inception through post-commercialization processes.
  • Kept equipment maintained, facility clean and organized and inventory stocked to maximize performance.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.
  • Defined clear targets and objectives and communicated to other team members.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.

Biochemical Research Scientist

BioTissue, Inc.
05.2017 - 04.2021
  • Performed stability testing, stress studies, quality control (QC) testing and prepared certificate of Analysis (CoA) for lot release of Internal Reference Material.
  • Documented deviations and investigated out of specifications/out of trend (OOS/OOT) results.
  • Performed assay development and assisted in writing CMC section for IND.
  • Developed new scalable method for purification of protein glycosaminoglycan (GAG)complex from placental tissue using Tangential Flow Filtration (TFF).
  • Assisted in new research and product development facility expansion and acquire equipment.
  • Wrote research papers, reports, reviews, and summaries regarding protein-GAG complex purification and quality testing.
  • Maintained confidentiality of all information related to donors of placenta tissue per HIPAA, internal, and other regulatory standards.

Senior Research & Product Development Specialist

BioTissue, Inc.
11.2015 - 04.2017
  • Developed internal reference material (IRM) for identity and potency assays for IND enabling studies.
  • Improved protein purification procedures to obtain higher yield and purity
  • Prepared, tested, and sent samples for In Vivo studies, namely, Proliferative Vitreoretinopathy (PVR) and Graft Versus Host Disease (GVHD) and analyzed the results.

Research & Product Development Specialist

BioTissue, Inc.
10.2013 - 06.2014
  • Demonstrated that human fresh and cryopreserved amniotic membrane are structurally, biochemically alike in anti-inflammatory activity
  • Responsible for writing and implementing SOPs, validation protocols, and documenting experimental data in compliance with regulations
  • Identified methods to improve purification of human placental protein complex
  • Performed In vitro assay by reunion of limbal niche cells (LNCs) and limbal epithelial progenitor/stem cells (LEPCs) in three-dimensional Matrigel and studied signaling pathways
  • Lead Florida Florida Agency for Health Care Administration (AHCA) inspections for Impression Cytology staining activities.

Laboratory & Manufacturing Technician

BioTissue, Inc.
05.2012 - 10.2013
  • Performed supply ordering and critical equipment selection and purchase
  • Assisted research scientists with technical writing and editing manuscripts for publications
  • Performed optimization of medium for maintaining limbal niche cells in vitro.
  • Performed isolation and characterization of adipose stem cells from human orbital fat.
  • Performed Impression Cytology staining and prepared test results for review and filing all related QC test records.

Education

MS - Biotechnology

Florida Institute of Technology
Melbourne, Florida
12.2011

B.Tech - Biotechnology

Padmashree Dr.D.Y.Patil University
Mumbai, India
06.2009

Skills

  • Quality: Data Integrity, compliance Knowledge, corrective Actions, Project Coordination, Regulatory Compliance and Documentation, Risk Management Strategies, Internal Audits, change Request Tracking and Document Writing and Review
  • Molecular Biology and Biochemistry: Western Blotting and densitometry, ELISA, Agarose electrophoresis, Real-Time PCR, immunostaining, silver staining
  • Aseptic handling tissue, tissue cryopulverization, Cell culture and maintenance of cell lines: mammalian and insect
  • Sample Processing: lyophilization, Ultracentrifugation, Histology staining
  • Computer skills: MS word, Excel, Power Point, Visio and Adobe
  • Soft Skills: Critical thinking, working independently and as team, excellent communication, and adaptability

Publications

  • Pax 6 Controls Neural Crest Potential of Limbal Niche Cells to Support Self-Renewal of Limbal Epithelial Stem Cells, Szu-Yu Chen, Anny MS Cheng, Yuan Zhang, Ying-Ting Zhu, Hua He, Megha Mahabole, Scheffer CG Tseng, Sci. Rep, 9 (1), 1-13, 2019
  • Heavy chain-hyaluronan/pentraxin 3 from amniotic membrane suppresses inflammation and scarring in murine lacrimal gland and conjunctiva of chronic graft-versus-host disease, Yoko Ogawa, Hua He, Shin Mukai, Toshihiro Imada, Shigeru Nakamura, Chen-Wei Su, Megha Mahabole, Scheffer C.G. Tseng, and Kazuo Tsubota, Sci. Rep, 7 (42195), 2017
  • Inhibition of Proliferation and Epithelial Mesenchymal Transition in Retinal Pigment Epithelial Cells by Heavy Chain-Hyaluronan/Pentraxin 3, Hua He, Ajay E. Kuriyan, Chen-Wei Su, Megha Mahabole, Yuan Zhang, Ying-Ting Zhu, Harry W. Flynn, Jr., Jean-Marie Parel, and Scheffer C. G. Tseng, Sci. Rep, 7 (43736), 2017
  • HC-HA/PTX3 Purified from Amniotic Membrane Promotes BMP Signaling in Limbal Niche Cells to Maintain Quiescence of Limbal Epithelial Progenitor/Stem Cells, Chen SY, Han B, Zhu YT, Mahabole M, Huang J, Beebe DC, Tseng SC, Stem Cells, 33 (11), 3341-3355, 2015
  • Structural and Biological Comparison of Cryopreserved and Fresh Amniotic Membrane Tissues, Tan EK, Cooke M, Mandrycky C, Mahabole M, He H, O'Connell J, McDevit TC, Tseng SC, J Biomater Tissue Eng, 4 (5), 379-388, 2014
  • Isolation and Characterization of Mesenchymal Progenitor Cells from Human Orbital Adipose Tissue Progenitor Cells for Human Orbital Fat, Chen SY, Mahabole M, Horesh E, Wester S, Goldberg JL, Tseng SC, Invest Ophthalmol Vis Sci, 55(8), 4842-52, 2014

Awards

Collaboration Award, BioTissue, Inc, 2019

References

  • Barb Eppler, VP of QA, Lacerta Therapeutics, phone: 352-339-0246, email: barb.eppler@gmail.com
  • Hua He, Ph.D., Principle Scientist, BioTissue, Inc., phone: 786-223-5152, email: hhe@biotissue.com
  • Szu Yu Chen, Ph.D., Senior Scientist, Lacerta Therapeutics, phone: 786-325-1495, email: szuyuc@gmail.com

Certification

  • Certified as The Certified Tissue Bank Specialist (CTBS) conferred by The American Association of Tissue Banks (AATB) in 2017 (Certification # 1017068)


  • Certified course for Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products organized by The Center for Professional Innovation & Education (CfPIE), at Los Angeles, CA in 2018


  • Certified course for Project Management Life Cycle by Rochester Institute of Technology in 2017

Additional Information

Volunteered for 'Hunger Fight' by packaging meals for families in need, August 2023

Languages

English
Full Professional
Hindi
Full Professional
Marathi
Native or Bilingual

Quote

Every problem is a gift—without problems we would not grow.
Tony Robbins

Timeline

QA Compliance Specialist II

Lacerta Therapeutics
03.2023 - 10.2023

Senior Scientist

Lacerta Therapeutics
07.2022 - 03.2023

Lab Manager

BioTissue, Inc.
05.2021 - 07.2022

Biochemical Research Scientist

BioTissue, Inc.
05.2017 - 04.2021

Senior Research & Product Development Specialist

BioTissue, Inc.
11.2015 - 04.2017

Research & Product Development Specialist

BioTissue, Inc.
10.2013 - 06.2014

Laboratory & Manufacturing Technician

BioTissue, Inc.
05.2012 - 10.2013

MS - Biotechnology

Florida Institute of Technology

B.Tech - Biotechnology

Padmashree Dr.D.Y.Patil University

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MEGHA MAHABOLE