Pharmaceutical Development and Manufacturing Center of Excellence
Kim A. Kew, PhDSenior Research ScholarDirector, Mass Spectrometry Services(252)328-9791
During our grant period, we have expanded our laboratory operations footprint, hired two dedicated scientists, quadrupled the number of students enrolled in pharmaceutical skills training courses offered in ECU Chemistry, supported the submission of proposals totaling nearly $7M in external funding requests by ECU researchers, and welcomed over 130 employees for professional development courses.
We invite you to navigate via the links below to learn more about how we can work together!
PDCD PharmaLaunch v2 VideoThe Greenville NC MSA is the Active Site for Pharmaceutical
Manufacturing. We are proud of our 50 year history of manufacturing
pharmaceuticals, and that is not by chance. We have abundant water,
concierge permitting, a trained workforce, and pharma-specific training
at Pitt Community College and ECU that was designed and enhanced over
the years by and for our pharmaceutical companies. In eastern NC, there
are over 9000 employees working directly in pharma manufacturing, and
there has been over $3 billion in investment. Our largest pharma
manufacturers, Thermo Fisher Scientific and Mayne Pharma, both expanded
in the past 4 years, creating over 500 jobs and investing over $250
million. Come be a part of our Active Site!
The Department of Chemistry offers two GMP-related courses. CHEM 7522 is designed for the graduate student in the chemical, biological, or biomedical sciences, and CHEM 4522 is targeted to the advanced undergraduate student who has excelled in Quantitative and Instrumental Analysis (CHEM 2250, 2251). The courses cover regulations, laws, and skills involved in good laboratory (GLP) and current good manufacturing practices (cGMP). This course is taught by Drs. Keith Holmes and Jack Pender, with significant contributions from regional industry partners. The importance of documentation and data integrity is stressed in these courses. Typical laboratory notebooks require from 130 – 160 pages of documentation (all figures/data tables properly identified and all data taped in and initialed/dated per GMP requirements).
CHEM 4522 can count towards the BS Chemistry and BS Biochemistry majors. CHEM 7522 may be used towards the MS Chemistry, including the Professional Science Masters, the MS Biomedical Engineering, and the Interdisciplinary Doctoral Program in the Biological Sciences. We also welcome qualified students from other programs wishing to take these courses as electives.
Course Content Includes
Email Dr. Holmes with any questions regarding registration.
We offer a variety of half- and full-day short courses on topics relevant to the pharmaceutical industry and beyond. These can be tailored to your company's needs, and offered on or off site. Contact Jack Pender with your custom training needs.
Quantitative High Performance Liquid Chromatography (HPLC) for Beginners with Lab March 6th and 7th, 2018, ECU Science and Technology Building
High Performance Liquid Chromatography Laboratory: Principles and PracticeJuly 25th and 26th, 2017, ECU Science and Technology Building
Scientific Discussion Around Patheon Opportunities, the Pharmaceutical
Industry, and An Overview of the Lyophilization Development ProcessFebruary 10, 2017, ECU Science and Technology Building
HPLC: System Suitability, Quantitation, and Data ReliabilityJanuary 6, 2017, ECU Science and Technology Building
HPLC: Back to BasicsDecember 16, 2016, ECU Science and Technology Building
Applying Building Block Innovations to Ensure Drug Product Quality (Chromatography)August 9 (Greenville) and August 10 (Wilmington), 2016Particle Size, Shape, and Chemical IdentificationJuly 13, 2016, ECU Science and Technology BuildingOOS: Don't Shoot the MessengerMarch 3, 2016, ECU Heart Institute
Our center typically charges for consumables, instrument time, and data analysis time. Depending on the size of the project, these prices may change based on the number of samples or complexity of the method. Savings may be realized if measurements are routinely made or, if appropriate, users are trained.
Please contact Dr. Kimberly Kew
(LC/MS, MALDI/MS) or Dr.
Jack Pender (Spectroscopy, Chromatography, ICP/MS) to discuss a scope of
work and to have a custom quote created.
For internal users, invoices can be generated and easily processed by Interdepartmental Transfer (IDT). For external users, an analytical services agreement can be executed at ECU and invoices sent to your company.
Personnel are available to support you as you construct proposals to submit for external funding. Dr. Kew or Pender can meet with you to discuss specific aims and collection of preliminary data. Collaborator roles and appropriate salaries/fees, as well as F&A, also can be discussed at these meetings so you can draft a thorough and accurate budget. A Facilities Description is linked below for your convenience, as are examples of a letter of support and biosketches. Please contact us regarding how we can help you craft a strong and competitive proposal.
The Department of Chemistry and the Pharmaceutical Development and Manufacturing Center of Excellence are committed to connecting regional employers with excellent candidates for internships and permanent jobs.