Latham Campbell

**** ******* ******, ************, ** 19151

267-***-****

abosuc@r.postjobfree.com

Summary: My experience includes laboratory cGMP system establishment and implementation, daily QC and R&D laboratory operations to ensure timely testing and product release, analytical technology transfer, managing stability programs, analytical supports for process scale-up and validation, preparation and implementation of SOPs, qualification for lab equipment and instruments, (IQ, OQ, and PQ), investigation on deviation and non-conforming results. Wrote and implemented stability protocols, analytical method development plans, method validation protocols/reports, and method transfer protocols/reports for pharmaceutical dosage forms and API.

Special Skills Software: Word, Excel, Outlook, Access, SLIM, LIMS, Empower, ChemStation, EZChrom Elite, MassLynx MS Software, Omnic 6.1a, and special software for pharmaceutical industry (such as E-Docs and TrackWise).

Instrumentation: Agilent 1100/1200; Waters Alliance 2695 HPLC Systems, Waters UPLC; Agilent GC 6890, Agilent GC/MS (6890 GC, 6100 MSD), Agilent LC/MS (1100 LC, 5973 Series MSD), Bruker Avance 600 MHz NMR, and Nicolet FTIR.

Expertise: HPLC, UPLC, GC, LC-MS, GC-MS, GPC, TLC, IR, AA, FTIR, KF, UV/VIS, Dissolution, and Wet Chemistry Techniques.

Regulatory: All laboratory work compliant to FDA, cGMP, SOP, and ICH guidelines.

Experience

2003 - Present Sr. Analytical Chemist Consultant: Precept Life Sciences, Herndon, VA.

Provide analytical support to medical devices, API formulation, raw materials, and finish products.Responsible for compliance with cGMP regulations, including remediation, establishment, and implementation of SOP’s, analytical method development and validation, sample testing, documentation management, and training program. Expertise in HPLC, GC, UV, NMR, FTIR, MS, GC/MS, LC/MS, dissolution, and wet chemistry. Provide analytical method development and validation. Design and conduct stability, impurity, and organic volatile impurities studies for API and drug products. Wrote and implemented stability, method transfer, and validation protocols/reports. Prepared and review analytical methods, SOPs, commissioning documents, and other appropriate documentation as needed to maintain regulatory compliance. Inititiated Change Control Request for existing cGMP documents. Performed the IQ, OQ, and PQ of new laboratory HPLC and GC systems. Conduct deviation, OOS, and OOT investigations. Recommended and implemented CAPA. Team Leader in charge of four consultants. Responsible for reviewing and releasing all analytical data compiled by the group. Oversee laboratory equipment qualification, calibration, and preventative maintenance programs. All work performed in strict cGMP environments.

2000-2003 Staff Scientist: DuPont Pharmaceutical Company, Wilmington, DE.

Performed analytical method development and validation for solid dosage forms using Distek, Vankel, and Logan apparatus 1 and 2. Utilized HPLC and UV/Vis to aid in analytical determinations. Involved in dissolution method investigations. Conducted cGMP investigations of commercial complaint samples, OOT, and OOS non-conforming test results. Recommended CAPA.Responsible for analytical method development,validation, and transfer. Managed and trained junior scientists and interns. Followed cGMP rules and FDA regulations.

1998-2000 Analytical Chemist: Global Systems Technologies, Egg Harbor, NJ.

Evaluated trace detection systems in the FAA's Aviation Research & Development laboratory and domestic airports. Prepared C4, Detasheet, and Semtex-H suspensions for particle size analysis and HPLC and LC/MS testing. Statistically treated and interpreted data derived from mass spectrometry (Ion Trap Mobility) analysis. Worked under National Security Clearance and GLP conditions.

19911998 Analytical Chemist: ESI, Inc., Cherry Hill, NJ.

Performed quality control testing of raw materials and finished injectable generic drug products in a strict cGMP environment.Operated HPLC, GC, AA, IR, and UV/VIS.Collected and statistically treated data.Promoted to Research and Development to support product development.Developed analytical methods and peer reviewed notebooks.

Education 1998 M.S., Analytical Chemistry Temple University Philadelphia, PA

1990 B.S., Chemistry and Biochemistry Temple University Philadelphia, PA

Contact this candidate