Experience

Tunnell Consulting, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Independent Consultant

  • Mar 2023 - Present

  CMC upstream process development and manufacturing consulting. Providing expertise in GMP manufacturing for drug substance for clinical trial materials; executing strategy and providing onsite troubleshooting; proactively engaging with the virtual project team; providing process support for documentation; finalizing and reviewing batch records; and attending weekly meetings with the team and CDMO. CMC upstream process development and manufacturing consulting. Providing expertise in GMP manufacturing for drug substance for clinical trial materials; executing strategy and providing onsite troubleshooting; proactively engaging with the virtual project team; providing process support for documentation; finalizing and reviewing batch records; and attending weekly meetings with the team and CDMO.



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Associate Scientist

  • Oct 2021 - Mar 2023

  Upstream lead for novel viral therapy programs; Modified vaccinia Ankara (MVA) and Herpes simplex virus (HSV-1). As lead I support process development and GMP manufacturing at external CDMOs. Responsible for batch record reviews, experimental design, data analysis and root cause investigations. Worked collaboratively with CMC to support phase 1 IND filings for both programs, authoring IND sections and detailed process flow diagrams to support submissions to Health Authorities (US and EU). In… Show more Upstream lead for novel viral therapy programs; Modified vaccinia Ankara (MVA) and Herpes simplex virus (HSV-1). As lead I support process development and GMP manufacturing at external CDMOs. Responsible for batch record reviews, experimental design, data analysis and root cause investigations. Worked collaboratively with CMC to support phase 1 IND filings for both programs, authoring IND sections and detailed process flow diagrams to support submissions to Health Authorities (US and EU). In addition I also support Adeno-associated virus (AAV) programs, by running Eppendorf Bioflow320s (3-40L) for drug substance. Additional analytic support by training colleagues of CsCl density gradients using ultra centrifugation. In addition to my scientific role, I play a critical part in business operations. I help managed Cell & Gene Therapy (C>) departmental capital budget, working with finance, business operations, procurement, and vendors to ensure timely and accurate capital purchases for the fiscal year and within established timelines. I supervised and directed all new laboratory equipment onboarding activities, entitlements, and scheduled maintenance as laboratory and equipment manager.

• Associate Scientist

  • Jul 2019 - Oct 2021

  In this role I played a instrumental part as scientific lead responsible for bringing online BTDS - API first gene therapy lab this included: • Managed $3M capital budget – responsible for acquisition of assets; worked with vendors and procurement to stay within budget and insure on time delivery and installation. • Oversaw all operations from start to finish; Used Six Sigma yellow belt skills to design a functional lab CAD drawing with architects. • Worked closely with the… Show more In this role I played a instrumental part as scientific lead responsible for bringing online BTDS - API first gene therapy lab this included: • Managed $3M capital budget – responsible for acquisition of assets; worked with vendors and procurement to stay within budget and insure on time delivery and installation. • Oversaw all operations from start to finish; Used Six Sigma yellow belt skills to design a functional lab CAD drawing with architects. • Worked closely with the construction and facility team to properly identify equipment utilities and placement. Led GT team through identification and sourcing of new equipment • Established safety practices for BSL2+ lab. Researched and developed required safety documentation. (BAR, RAC and large-scale exposure plan). Plan was approved first time by IBC, no safety events since implementation. Upstream lead on MVA and HSV-1 programs, working collaboratively with external CMOs. Hands on support for AAV programs, including running bioreactors for drug substance and analytical testing (ELISA and qPCR)



Gene Therapy Program | University of Pennsylvania

• United States
• Biotechnology Research
• 100 - 200 Employee

• Resource Technologist C

  • Feb 2019 - Jul 2019

  Produced and purified research grade AAV vectors for basic, preclinical, clinical, and translational studies. Supported GMP process-comparable manufacturing of AAV vectors for IND-enabling/Pharmacology/Toxicology studies, including proper documentation for batch record forms, SOPs, and equipment records. Hands on experience in downstream purification techniques utilizing density gradient ultra-centrifugation, Tangential Flow Filtration and AKTA column chromatography (AEX and Affinity).

• Resource Technologist B

  • Apr 2016 - Feb 2019

  Responsible for the production and purification of research grade vectors (AAV) for basic, preclinical and translational studies.



DuPont Pioneer

• Research Assistant; Plant Protection Lead Development Group

  • Oct 2015 - Mar 2016

  Managed daily operations of the Arabidopsis model system for quick and easy molecular genetic studies on new plant protection vectors for trait groups. Transformed over 100 new plasmids into Agrobacteria creating plates, bacterial cultures and glycerol stocks. Utilized the floral dip transformation method to quickly cultivate and score efficiency of T1 transgentic seed for use in growth assays to evaluate phytotoxicity. Growth assays were conducted in 2 weeks’ time using Lemna-tec software to… Show more Managed daily operations of the Arabidopsis model system for quick and easy molecular genetic studies on new plant protection vectors for trait groups. Transformed over 100 new plasmids into Agrobacteria creating plates, bacterial cultures and glycerol stocks. Utilized the floral dip transformation method to quickly cultivate and score efficiency of T1 transgentic seed for use in growth assays to evaluate phytotoxicity. Growth assays were conducted in 2 weeks’ time using Lemna-tec software to analyze and interrupt growth patterns between wild-type and transgenetics. Collected and lyophilized leaf samples to be analyzed by qPCR, western bolt, and mass spectrometry. Responsible for all daily maintenance of plants including growth chambers upkeep, watering, culling, seeding flats and herbicide sprays. Worked closely with Principal Investigators and other Senior Research Associates in a positive and dynamic atmosphere.

• Research Assistant; Soybean Transformation Research Group

  • Jul 2014 - Oct 2015

  Responsible in designing and implementing new and improved SOPS for Agrobacterium and biolistic particle based transformation systems for soybeans, to create a faster and a more efficient platform. Proficient in both organogenesis and embryogenesis plant regeneration systems. All work was performed in a flow hood, with excellent sterile technique to maintain soybean stock cultures and generate transgenic events and plants for molecular analysis and seed production. Conducted all experiments… Show more Responsible in designing and implementing new and improved SOPS for Agrobacterium and biolistic particle based transformation systems for soybeans, to create a faster and a more efficient platform. Proficient in both organogenesis and embryogenesis plant regeneration systems. All work was performed in a flow hood, with excellent sterile technique to maintain soybean stock cultures and generate transgenic events and plants for molecular analysis and seed production. Conducted all experiments using a DNA fluorescence marked in order to track progress under a fluorescent microscope, utilizing Leica Application System to photograph over 1,500 images of transgenic events. Employed restriction enzyme digests and gel electrophoresis on new transformation vectors for QC. Transformed and extracted DNA from E. Coli and Agrobacterium to be used for cloning and bacterial cultures. Presented research to laboratory team on a regular basis. Demonstrated aptitude to learn quickly and work independently. Thought critically about scientific ideas and worked steadily and diligently while maintaining a clean and safe laboratory environment.



Longwood Gardens

• United States
• Zoos and Botanical Gardens
• 300 - 400 Employee

• Research Assistant

  • May 2013 - Jul 2014

  Curator of the KEN Herbarium at Longwood Gardens. Worked closely with the plant records department to ensure proper field collections and preservation of over 1,500 new herbarium specimens. Designed and implemented the digital system for photographing all 13,000 herbarium specimens for an online digital archive, making the collection easily more accessible for to the public. Collaborated with an external organization for in field collection and cryopreservation of plants samples to fit their… Show more Curator of the KEN Herbarium at Longwood Gardens. Worked closely with the plant records department to ensure proper field collections and preservation of over 1,500 new herbarium specimens. Designed and implemented the digital system for photographing all 13,000 herbarium specimens for an online digital archive, making the collection easily more accessible for to the public. Collaborated with an external organization for in field collection and cryopreservation of plants samples to fit their needs for further molecular analytical studies. Enjoyed teaching continuing education courses and outreach children activities on the importance of herbaria. Show less Curator of the KEN Herbarium at Longwood Gardens. Worked closely with the plant records department to ensure proper field collections and preservation of over 1,500 new herbarium specimens. Designed and implemented the digital system for photographing all 13,000 herbarium specimens for an online digital archive, making the collection easily more accessible for to the public. Collaborated with an external organization for in field collection and cryopreservation of plants samples to fit their… Show more Curator of the KEN Herbarium at Longwood Gardens. Worked closely with the plant records department to ensure proper field collections and preservation of over 1,500 new herbarium specimens. Designed and implemented the digital system for photographing all 13,000 herbarium specimens for an online digital archive, making the collection easily more accessible for to the public. Collaborated with an external organization for in field collection and cryopreservation of plants samples to fit their needs for further molecular analytical studies. Enjoyed teaching continuing education courses and outreach children activities on the importance of herbaria. Show less