Kelly Gross, MBA, MS

Kelly gross, mba, ms

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location of Kelly Gross, MBA, MSPhiladelphia, Pennsylvania, United States
Phone number of Kelly Gross, MBA, MS+91 xxxx xxxxx
Followers of Kelly Gross, MBA, MS960 followers
  • Timeline

    Dec 2007 - Aug 2011

    Barista

    Borders Books
    Apr 2010 - May 2011

    Undergraduate Student Researcher

    Angelo State University
    San Angelo, TX
    Oct 2011 - Dec 2011

    Graduate Student Consultant

    Sanguine Biosciences, Inc.
    Jan 2012 - Mar 2013

    Graduate Student Research Assistant

    Western University
    Feb 2012 - May 2012

    Graduate Student Assistant

    Keck Graduate Institute
    Jun 2012 - Aug 2012

    Business Development Specialist

    University of Nebraska Medical Center
    Aug 2012 - May 2013

    Graduate Student Researcher

    Terumo BCT
    Aug 2013 - Dec 2015

    PHD Candidate

    Tulane University
    Greater New Orleans Area
    Jan 2014 - Dec 2015

    Bartender

    Verret's Lounge
    Feb 2016 - Aug 2019

    Senior Facilities/Metrology Technical Operations Specialist

    WuXi Advanced Therapies
    Greater Philadelphia Area
    Sept 2019 - Oct 2022

    Facilities Compliance Specialist

    Regeneron Pharmaceuticals, Inc.
    Apr 2022 - Mar 2023

    Hostess Server

    CHEZ MIKE
    Mar 2023 - Jan 2024

    QA Technical Writer

    UPM Pharmaceuticals
    May 2024 - now

    Contract Technical Writer

    CMC Turnkey Solutions
    Current Company
    Aug 2024 - now

    Lab Operations Specialist

    The Janssen Pharmaceutical Companies of Johnson & Johnson
  • About me

    QA/QC Technical Operations Specialist

  • Education

    • Angelo state university

      2008 - 2011
      Bs biochemistry 3.61

      Activities and Societies: Alpha Chi National Honors Society (inducted 2010), American Chemical Society Student Chapter (secretary; president), Animeyhem, Beta Beta Beta Biological Honors Society (honors member), Honors Student Association (treasurer), Iota Sigma Pi National Honors Society for Women in Chemistry (inducted 2011), Screeners (vice-president), Video Game Association Graduated with High University Honors and cum laude Latin honorsTransfer student from Temple UniversityMinors in biology and psychologyAdvanced History Study Abroad- July-August 2010, Germany & Czech RepublicACS National Conference Attendee- April 2010 San Francisco; April 2011, Anaheim CATri-Beta Regional Conference Attendee- Spring 2009-2011, Lake Texoma OKTri-Beta Regional Conference Participant- Spring 2011, Lake Texoma OKHead Student Organizer for the Green… Show more Graduated with High University Honors and cum laude Latin honorsTransfer student from Temple UniversityMinors in biology and psychologyAdvanced History Study Abroad- July-August 2010, Germany & Czech RepublicACS National Conference Attendee- April 2010 San Francisco; April 2011, Anaheim CATri-Beta Regional Conference Attendee- Spring 2009-2011, Lake Texoma OKTri-Beta Regional Conference Participant- Spring 2011, Lake Texoma OKHead Student Organizer for the Green Chemistry Conference, January-April 2011, San Angelo TXStudent Volunteer for Girl Scouts of America STEM workshop 2009-2011, San Angelo TX Show less

    • Lower merion high school

      2003 - 2007
      High school diploma 3.90

      Activities and Societies: Academic Decathlon, JV and Varsity Volleyball (co-captain Fall 2006 season), National Honors Society, Players Theater Company (Crewhead of Lighting and Sound crew for 3 productions). Top 10% Received distinguished recognition for mathematicsCourses were all honors unless there was no honors optionAP biology and chemistry were taken senior yearMember & tutor of the National Honors Society

    • Keck graduate institute

      2011 - 2013
      Master of business administration - mba pharmaceutical sciences
    • Tulane university

      2013 - 2015
      Master's degree physiology, general 3.60

      Activities and Societies: Biomedical Science Student Association (BMSSA)

  • Experience

    • Borders books

      Dec 2007 - Aug 2011
      Barista

      • Sustained a fast-pace and friendly customer service in terms of coffee, food, and gifts.• Ensured all café and seating areas were clean and adequately stocked throughout shift.• Developed new employee training materials and trained new baristas.• An introduction to basic inventory and sales from Café Manager.

    • Angelo state university

      Apr 2010 - May 2011

      • Obtained Institutional Review Board approval for studying <20 human subjects. • Designed a metabolic study which tried to quantify a relationship between psychological stress and glucose metabolism in first year college students. • Obtained funding from 2 different sources for materials needed. • Personally worked with 13 subjects taking fasting blood glucose, blood pressure, and stress levels. • Presented results at the Tri-Beta Biological Honors Society regional meeting in March 2011. Show less

      • Undergraduate Student Researcher

        May 2010 - May 2011
      • Teaching Assistant

        Aug 2009 - May 2011
      • Student Tutor

        Aug 2009 - May 2011
      • Book Seller

        Apr 2010 - Dec 2010
    • Sanguine biosciences, inc.

      Oct 2011 - Dec 2011
      Graduate student consultant

      • A 3-month project involving new avenues in the genetic sequencing market.• Drafted interview questions focused on genetic sequencing availability, database creation, and HIPAA regulations.• An introduction to database construction and security/privacy requirements.

    • Western university

      Jan 2012 - Mar 2013
      Graduate student research assistant

      • An independent research project under Dr. Bradley Andresen regarding the helical domain (HD) on heterotrimeric G-protein coupled receptors. • Introduction to adherent cell culture utilizing HEK 293-T mammalian cell culture.• Performed transfection and PCR methods to over-express and confirm HDs on a purified plasmid.• Assisted KGI Center for Biomarker Research staff with protein co-immunoprecipitation and identification. • • Learned about experimental design, basic biochemical research techniques, time management, and scientific writing. Show less

    • Keck graduate institute

      Feb 2012 - May 2012
      Graduate student assistant

      • Assisted Business professor with the "Science and Business of Medicinal Chemistry" undergraduate class at Claremont McKenna College.• Created medicinal chemistry commercialization projects for 21 undergraduate students by reviewing primary literature regarding medicinal compounds.• Assisted student with understanding organic chemistry mechanisms and beginner pharmacokinetic and pharmacodynamic principles.

    • University of nebraska medical center

      Jun 2012 - Aug 2012
      Business development specialist

      • Assessed the commercialization of a new nanoparticle drug delivery system for neurodegenerative diseases (mainly Parkinson's) designed by Elena Batrakova and her lab.• Designed PowerPoint presentations which explained scientific proof of principle, market analysis, and initial drug valuation.• Interviewed key researchers and laboratory technicians regarding experimental design and delivery mechanism.• Assembled a start-up business plan for laboratory and UNME Technology Transfer department. • Conducted a market analysis regarding the neurodegenerative disease and nanomedicine markets, including challenges in strategy and regulatory affairs. Show less

    • Terumo bct

      Aug 2012 - May 2013
      Graduate student researcher

      • Masters thesis capstone project for the professional science MBS degree sponsored by Terumo BCT.• Conducted primary research on the opportunities and growth of the US blood safety market.• Personally conducted 20+ interviews with key opinion leaders regarding whole blood history and usage.• Composed and published a survey distributed to individuals in the academic and corporate blood industries (including fractionators, blood bank employees, clinicians, and researchers).• Created and presented corporate PowerPoint with market research results to Terumo BCT upper management. Show less

    • Tulane university

      Aug 2013 - Dec 2015

      • Researched the effects of streptozotocin induced Type 1 diabetes on female C57BL/6 mice as most studies focus on the male mouse model - focusing on angiotensinogen and isoprostane expression differences.• Maintained C57BL/6 mice colonies by ensuring cages were clean, stocked, and mice genotyped.• Trained and setup mice for tail-cuff blood pressure measurements. • Optimized and proceduralized alternative usage for commercial ELISA assay utilizing different sample media.• Documented all laboratory activities and research observations, including materials utilized, within laboratory notebooks.• Assisted laboratory group when collecting rodent blood, organs, and specific tissue samples for further analysis.• Conducted one insertion surgery in which an extended-release hormone capsule was placed and stitched within mouse cavity. Show less Aug-Dec 2013 - Advanced Molecular Biology Lab • Co-taught with one other graduate student a group of 28 undergraduate students in topics including PCR, gel electrophoresis, southern blotting, etc.• Wrote examinations and homework assignments according to professor curriculum.• Graded exams, homework and lab notebooks according to professor rubric.• Responsible for troubleshooting procedures and equipment as required. Jan-May 2014 - Non-Major Hereditary and Society Lab• Co-taught with one other graduate student a group of 28 undergraduate students in topics including cell morphology & function, cell division, Mendelian genetics, evolution, etc.• Wrote examinations and homework assignments according to professor curriculum.• Graded exams, homework and lab notebooks according to professor rubric.Aug-Dec 2014 - Advanced Cell Biology Lecture• Proctored lecture exams and answered questions as needed• Graded exams and homework according to professor rubric.Jan-May 2015 - Advanced Cell Biology Lab• Solely responsible for 14 undergraduate students in topics including cell culture, immunofluorescence and IHC, signal transduction, cell differentiation, etc.• Wrote examinations and homework assignments according to professor curriculum.• Graded homework and lab notebooks according to professor rubric.• Responsible for troubleshooting procedures and equipment as required. Show less

      • PHD Candidate

        Oct 2014 - Dec 2015
      • Graduate Student Instructor

        Aug 2013 - May 2015
    • Verret's lounge

      Jan 2014 - Dec 2015
      Bartender
    • Wuxi advanced therapies

      Feb 2016 - Aug 2019

      • Solely responsible for investigating for all Facilities/Metrology non-conformances.• Managed all Philadelphia Facilities non-conformances, change controls, and continuous improvement project CAPAs.• Facilities/Metrology Representative for internal and external audits, change control review board, and continuous improvement projects.• Wrote and managed all Facilities/Metrology related change controls in accordance with FDA & ISPE regulations. • Quality Systems SME responsible for training efforts and optimization for MasterControl Software Suite. • Interim Facilities Manager for the dedicated gene therapy and viral vector manufacturing facility - maintained all building operations, personnel, purchases, and documentation approval in lieu of Facilities Manager long term absences. Show less • Composed and facilitated 50+ change controls related to Manufacturing processes and equipment systems, in accordance with FDA and ISPE regulations and guidelines. • Completed 50+ root cause analyses and coordinated CAPAs for non-conformances related to cGMP manufacturing processes - specializing in facilities and environmental monitoring (EM) excursions. • Manufacturing Representative on the EM committee, an continuous improvement group dedicated to sterility assurance.• Qualified Trainer for MasterControl Change Control module - assisted Quality Systems department by developing and trainings 100s of associates, seniors, and management in the new module. Show less • Manufacturing Operator for gene therapy and viral vector applications, according to ISO levels 5, 7, and 8 cleanroom practices and criteria.• SME for two innovative T-cell gene therapies - wrote over 400 pages of cGMP batch records, trained 11 associates and management in specialized equipment systems, and coordinated results with Technology Transfer department. • Aided Manufacturing Technical Operations department by composing non-conformances related to manufacturing process deviations, EM excursions, and equipment malfunctions. Show less

      • Senior Facilities/Metrology Technical Operations Specialist

        Jan 2018 - Aug 2019
      • Manufacturing Technical Operations Specialist I

        Feb 2017 - Jan 2018
      • Gene-Mediated Manufacturing Associate I

        Feb 2016 - Feb 2017
    • Regeneron pharmaceuticals, inc.

      Sept 2019 - Oct 2022
      Facilities compliance specialist

      • Performed risk and root cause analyses for 100s of non-conformance events specializing in calibration and process requirement deviations.• Maintained Facilities investigation evidence and sample drop-off program between Facilities Compliance and QA Validation or Production Maintenance per investigation SOP requirements• Trained compliance specialists, including seniors, regarding root cause analysis, creating CAPAs, and technical writing topics.• Managed 2 direct reports daily operations and needs for job performance, training, and compliance. • Facilities Investigation SME on pipette non-conformances - completing all pipette related events, assisting in pipette risk assessments, developing training materials, and training personnel Show less

    • Chez mike

      Apr 2022 - Mar 2023
      Hostess server

      • Welcomed all in-house and to-go customers, ensuring all were greeted warmly and served promptly.• Assisted servers and cooking staff regarding customer requests and orders.• Delivered food and drinks from kitchen and bar while maintaining tickets.

    • Upm pharmaceuticals

      Mar 2023 - Jan 2024
      Qa technical writer
    • Cmc turnkey solutions

      May 2024 - now
      Contract technical writer
    • The janssen pharmaceutical companies of johnson & johnson

      Aug 2024 - now
      Lab operations specialist

      • Contract through Black Diamond Network

  • Licenses & Certifications