Carrie Shults Email and Phone Number
Results-oriented executive with comprehensive background in research and development, aseptic processing, and clinical manufacturing operations, including quality assurance, strategic planning, budgeting, and resource allocation. Proven success improving operational performance, increasing regulatory GMP compliance (US and EU), and overseeing continuous growth of diverse multifunctional team. Collaborative leader dedicated to creating engaging workforce and promoting culture of diversity, equity, and inclusion. Yes, I am also a microbiology nerd and lover of contamination control! Over 30 years of experience learning and growing!
Lyophilization Technology, Inc
View- Website:
- lyotechnology.com
- Employees:
- 28
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Associate Director, Clinical ManufacturingLyophilization Technology, Inc Nov 2018 - PresentWarminster, Pa -
Group Leader/Area Manager Of Development Sciences, Project Director, Research ScientistLyophilization Technology, Inc Dec 2007 - Present•Supervise, oversee, train, and develop Development Technicians and Technical Associates.•Oversee condition of the Development Sciences Area, to encompass the Development and Process Laboratories and all equipment and instruments.•Conduct and oversee client projects including product and process development, technical support, validation, and troubleshooting.•Coordinate and oversee Toxicological and Clinical Trial Material utilizing aseptic processing and containment techniques, including batch preparation and processing.•Project Director managing all aspects of research studies for lyophilized preparation from the initial study design with study sponsors through analysis of data and report preparation.•Oversee and review thermal analysis projects including freeze-drying microscopy, electrical resistance measurements and differential scanning calorimetry.•Direct thermal analysis and development laboratories’ personnel and instrumentation.•Supervise laboratory technicians to successfully complete projects.•Compose and review standard operating procedures.•Investigate fundamental principles and advance the applied science through basic and applied research studies. -
Group Leader Development Sciences And Clinical ManufacturingLyophilization Technology, Inc Dec 2007 - Present -
Senior Research AssociateCardiology Dept Jul 2004 - Aug 2005Managed morphology core lab and gene characterization projects.Embed, sectioned, stained and analyzed various cardiac tissues. Designed and performed studies to characterize specific genes that play a role in cardiac malformation and disease.
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Associate ScientistGlaxosmithkline May 2002 - Jan 2004responsible for growth and cryopreservation of microbial cultures and mammalian cell lines utilizing aseptic technique.Quality control testing of preserved samples for viability and sterilityDistributed and tracked biological samples GSK worldwide.Designed, tested and implemented a web based catalogue system for biologicals. -
Research ScientistMerck & Co., Inc Apr 2001 - Oct 2001Wrote and reviewed assay reagent qualification procedures and reports.Performed and troubleshoot LAL (bacterial endotoxin) assays following SOPs within a GMP environment. Authored LAL qualification packages and deviation investigation reports.
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Research ScientistMerck & Co., Inc Aug 2000 - Feb 2001Developed and maintained a Caco-2 cell culture line for transport studies. Animal handling of dogs and rats for dosing and blood sampling for drug candidates to establish preliminary dosage requirements and safety.
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Scientific TechnicianFox Chase Cancer Center Jan 2000 - Aug 2000Responsible for all cell culture and animal husbandry.Amplified viral stocks for studies involving measles virus inoculation.Utilized transgenic mice for various viral studies. -
Laboratory ManagerUniveristy Of Pennsylvania Sep 1999 - Jan 2000Responsible for ordering equipment and reagents as well as maintaining lab.Cell/tissue culture, western blotting, protein biochemistry work.Collaborated on research projects focused on chondrocyte development.
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Cell Culture TechnicianImmune Response Corp Apr 1999 - Aug 1999Grew, split and chemically inactivated large titers of HIV infected mammalian cells for immunotherapeutic use.All work performed following cGMPs and Standard Operating Procedures.Prepared and implemented master batch records.
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Research Technician IiChildren'S Hospital Aug 1997 - Apr 1999Investigated asthma by identifying and analyzing different airway cell messengers that play a role either prohibiting or inducing an asthmatic reaction.Cultured smooth muscle tissue and various cell lines.Authored and reviewed publications. -
Co-Op ScientistFox Chase Cancer Center Sep 1995 - Dec 1996working with a recombinant phage antibody system using various molecular biology techniques such as agarose gel electrophoresis, spectroscopy, PCR and transfection. Laboratory maintenance and reagent preparation.
Carrie Shults Education Details
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Biology, General -
Neumann UniversityBiology And Chemistry
Frequently Asked Questions about Carrie Shults
What company does Carrie Shults work for?
Carrie Shults works for Lyophilization Technology, Inc
What is Carrie Shults's role at the current company?
Carrie Shults's current role is Associate Director, Clinical Manufacturing at Lyophilization Technology, Inc.
What schools did Carrie Shults attend?
Carrie Shults attended Drexel University College Of Medicine, Neumann University, Neumann University.
Who are Carrie Shults's colleagues?
Carrie Shults's colleagues are Alaina Blatnick, Alison Mutchler, Nutsa Tskipurishvili, Michael Thomas, Bilal Ahmad, Alex Hogard, Lani Mcmullan.
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