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Aseptic Technique, Cell Culture, CAR-T

Location:
Florham Park, NJ
Salary:
85000
Posted:
June 22, 2020

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Resume:

Killian O’Gorman

Scientist *** Rushmore Court Florham Park, NJ

***** 862-***-**** addz00@r.postjobfree.com

PERSONAL

STATEMENT

Passionate and committed to making a difference in the fields of cellular biology and oncology, with specific focus on neurological sciences, psychological health and wellbeing. PROFESSIONAL

EXPERIENCE

Novartis - Morris Plains, New Jersey - Cell Processing Specialist (CAR-T Specialist) 1&2

September 2019 - PRESENT

Responsible and trained in processing and manufacturing the Chimeric Antigen Receptor-Therapy (CAR-T) Kymriah from start to completion; A patient derived clinical and commercial cellular immunotherapy product used for the treatment of Acute Lymphoblastic Leukemia (ALL) and Diffuse Large B-Cell Lymphoma (DLBCL). I am conscious of all cGMP regulations and FDA guidelines applicable to biologics and cell therapy manufacturing. I have experience and understanding of aseptic technique, including gowning and operation in an: ISO 8, ISO 7 and ISO 5 environment. I am qualified and trained in validating and correcting the batch records associated with the product Kymriah, I have helped to make the process more productive and effective through the use of giving insightful ideas gained through hands on experience processing the CAR-T as to improve the efficiency of the process. I have experience working cross functional assignments with the QA and QC departments in determining root cause events that occur during the process and where potential risk aversion could be put in place. I have experience training newer operators how to perform parts of the process and the ability to use the systems involved in production and manufacturing of the CAR-T, Kymriah such as LIMS, SAP, and MES. I have taken responsibility for hosting daily pre-processing team meetings to go over day to day functions, announcements, and activities. As well as helping to communicate to management in easier ways to schedule people for their processing roles. I possess in depth knowledge and ability to perform and assist in the creation of the CAR-T Kymriah. Novartis - Morris Plains, New Jersey - Cell Processing Associate

June 2018 - September 2019

Responsible for cell washing and intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. I am conscious of all cGMP regulations and FDA guidelines applicable to biologics and cell therapy manufacturing. I have experience and understanding of aseptic technique, including gowning and operation in a clean room environment: ISO 8, ISO 7 and ISO 5. I am qualified and trained in producing the media used within the process of product production, as well as validating and correcting the batch records associated with the product.

Execupharm (Merck) - Rahway, New Jersey - Associate Specialist

January 2017 - June 2018

Responsible for workflows related to the receiving, labeling, storage, subdivision, and shipment of active pharmaceutical ingredients, and GMP materials in accordance with local and global, SOP’s, cGMP’s, and federal regulatory guidelines, ensuring all the required documentation, associated with the product pricing, and handling including SDS, MSDS are accurately prepared, prior to shipments as to allow for the products to be shipped domestically and internationally, following the guidelines according to each country. Ability to lead and manage, communications between third party buyers. Used aseptic techniques in both ventilated balance enclosures and glove boxes to measure and weigh out chemicals with OEB 2, 3 and 4.

GeneDx - Gaithersburg, Maryland - DNA Extraction Technologist (Centralized Alliquotting and Normalized Department, CAND)

October 2016 - December 2016

Responsible for the labeling and distribution of DNA sample aliquots and dilutions used by other teams for downstream testing of genetic disorders and diseases. Also responsible for the condensing of DNA samples from eppendorf tubes into a system of micronic tubes for archiving patient DNA for future testing using the Hamilton machine and Hamilton run programs. Aliquoted samples of DNA from both tissue and blood samples into 96 well plates in order to keep the archive of patients sample, and easily accessible. RELATED EXPERIENCE GettaGrip -

Glassboro, New Jersey - Volunteer

September 2014 - October 2015

At the time a startup company focused on creating a topically applied friction modifier with hydrophobic characteristics for grip enhancement in athletic application. The initial project has been to design a product for grip enhancement in competitive diving. Worked with a team to create formulations for a base product, then qualitatively tested products for product goals, and were modified based on the characteristics that we were looking to achieve. Millburn Short Hills Volunteer First Aid Squad - Short Hills, New Jersey - Emergency Medical Technician (EMT-B) for the State of New Jersey June 2012 - June 2016

Responsible for providing the best emergency medical assistance and care possible under my scope of practice. Working in the town of Millburn Short hills and local areas, neighboring towns and highways through the 911 New Jersey dispatch system. Trained in advanced bandaging and blood borne pathogens. EDUCATION

Rowan University, Glassboro, New Jersey -

Biology September 2012 - June 2016

Bachelors of Sciences in

Biology.

Copenhagen Business School - online course,

Coursera

September 2019 - October

2019

An introduction to consumer neuroscience and

neuromarketing

SKILLS AND

CERTIFICATIONS

LABORATORY AND CLEAN ROOM

SKILLS:

GMP Trained and Certified, HPPE (half mask and full mask), Advanced bandaging & first aid, AED/CPR, Cell culturing, Aseptic Technique, Alloquotting, Bioreactors, NC-200, Met-One, SAS, Pipetting and Serological Pipetting, Preparation of Media, Reagents and Buffers, Gel Electrophoresis, Polymerase Chain Reaction, DNA extraction, Distillation, Western Blotting, Flow Cytometry, ELISA

SOFTWARE

SKILLS:

SAP, MES, LIMS, LMS, Real time monitoring systems, Neurovision, JMP11, GeneWeb, ChemCart, ChemDraw, Social Media

Microsoft Office; Word, Powerpoint, Excel,

OneNote

Adobe Suite; Photoshop, Illustrator, After

effects

OTHER

SKILLS:

PADI SCUBA

CERTIFIED



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