Carrie Shults

Carrie Shults Email and Phone Number

Associate Director, Clinical Manufacturing at Lyophilization Technology, Inc @ Lyophilization Technology, Inc
ivyland, pennsylvania, united states
Carrie Shults's Location
Warminster, Pennsylvania, United States, United States
About Carrie Shults

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!

Carrie Shults's Current Company Details
Lyophilization Technology, Inc

Lyophilization Technology, Inc

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Associate Director, Clinical Manufacturing at Lyophilization Technology, Inc
ivyland, pennsylvania, united states
Employees:
28
Carrie Shults Work Experience Details
  • Lyophilization Technology, Inc
    Associate Director, Clinical Manufacturing
    Lyophilization Technology, Inc Nov 2018 - Present
    Warminster, Pa
  • Lyophilization Technology, Inc
    Group Leader/Area Manager Of Development Sciences, Project Director, Research Scientist
    Lyophilization 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.
  • Lyophilization Technology, Inc
    Group Leader Development Sciences And Clinical Manufacturing
    Lyophilization Technology, Inc Dec 2007 - Present
  • Cardiology Dept
    Senior Research Associate
    Cardiology Dept Jul 2004 - Aug 2005
    Managed 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.
  • Glaxosmithkline
    Associate Scientist
    Glaxosmithkline May 2002 - Jan 2004
    responsible 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.
  • Merck & Co., Inc
    Research Scientist
    Merck & Co., Inc Apr 2001 - Oct 2001
    Wrote 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.
  • Merck & Co., Inc
    Research Scientist
    Merck & Co., Inc Aug 2000 - Feb 2001
    Developed 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.
  • Fox Chase Cancer Center
    Scientific Technician
    Fox Chase Cancer Center Jan 2000 - Aug 2000
    Responsible for all cell culture and animal husbandry.Amplified viral stocks for studies involving measles virus inoculation.Utilized transgenic mice for various viral studies.
  • Univeristy Of Pennsylvania
    Laboratory Manager
    Univeristy Of Pennsylvania Sep 1999 - Jan 2000
    Responsible 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.
  • Immune Response Corp
    Cell Culture Technician
    Immune Response Corp Apr 1999 - Aug 1999
    Grew, 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.
  • Children'S Hospital
    Research Technician Ii
    Children'S Hospital Aug 1997 - Apr 1999
    Investigated 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.
  • Fox Chase Cancer Center
    Co-Op Scientist
    Fox Chase Cancer Center Sep 1995 - Dec 1996
    working 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

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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