Jack E. Pender Email & Phone Number

Greenville, Nc, Us

Greenville, North Carolina Area

Designed and implemented a successful deformulation program for evaluation of commercial products under consideration for generic formulation. (Perfect Record!!) Performed method development, method validation, and prototype evaluation. Assisted the QC Group with challenging OOS and OOT investigations through technical guidance, data trending, and independent laboratory studies. Led validation activities for improved methods including validation, method revision, and change control documentation. Coordinated method transfers between the Development and Quality Control Groups. Reviewed procedures, validations, and stability data to proactively identify potential challenges in method transfer and long-term robustness.Designed, equipped, and managed a new R&D laboratory at Metrics Inc. including developing operating procedures and implementation of new analytical technologies (DOE software, charged aerosol detection, and in-situ fiber-optic UV/Vis measurement for dissolution).Led the cross-functional team upgrading Metrics’ technical training program including conversion from paper to electronic systems and installation of training teams. Managed 1 Analytical Chemist and 0-2 interns.Notable Achievement: Identified and mitigated multiple sources of variability and bias in a preservative method for two ophthalmic products.Current Interests: Analytical QbD, statistical design of experiments, charged aerosol detection, and in-situ fiber optic UV/Vis measurement for dissolution

Greenville, North Carolina Area

Served as a technical resource for Analytical Services, Business Development, and Quality Assurance Departments.Performed method development, validation, data review, and troubleshooting activities for analytical groups supporting external clients. Managed testing for small analytical clients and special projects. Trained analysts on laboratory techniques and validation practices.Authored an internal guidance document on the use of signal-to-noise ratios to address compendial requirements and considerations for determination using Empower2. Authored technical training protocols for Dissolution and pH Meters for Quality Assurance.Supported the company-wide upgrade of pH meter instrumentation including authoring SOPs, creating pH buffer temperature dependency tables, leading group training sessions, and troubleshooting.Drafted technical marketing literature and served as analytical representation for the Business Development Department. o Developed literature to present instrumentation, capabilities, and services offered o Drafted a marketing flier regarding melamine adulteration and the need for testing o Served as analytical representation at select industry conferences

Greenville, North Carolina Area

Primary point-of-contact and project manager for analytical activities supporting development to Phase III products for 3-4 clients. Collaborated with internal, client, and third party analytical, manufacturing, and quality representatives to ensure quality and timing goals were met.Led project meetings to update progress, resolve problems, and coordinate future activities.Scheduled and supervised the daily laboratory activities of 3-4 analysts performing release, reference standard qualification, stability, validation, transfer, and other miscellaneous testing. Reviewed GMP documentation such as laboratory notebooks, analytical reports, stability reports, certificates of analysis, deviations, investigations, protocols, and validation reports.Ensured deviation and investigation CAPAs were performed and all documentation was completed in a timely manner. Coordinated outsourced testing and specialized internal testing such as microbiology and metals analysis to support client products.Notable Achievement: Lab Group maintained monthly billing over 145% of the company target.

Greenville, North Carolina Area

Managed analytical activities for multiple client projects under the guidance of a Group Leader. Progressively assumed responsibility for management of analytical activities for 1-4 clients including guiding client communication through conference calls, emails, and phone calls. Performed and supervised method development, validation, transfer, stability, investigations, and other aspects of drug product support.Generated and reviewed GMP documentation such as laboratory notebooks, analytical reports, certificates of analysis, deviations, protocols, and validation reports. Managed daily activities of 2-3 analysts.Continuously met or exceeded monthly billing goals.Notable Achievement: Identified the cause of super-potent dissolution results to be excessive binding then release of the analyte from nylon syringe filters that increased with the age of the filter.

Greenville, North Carolina Area

Laboratory chemist performing analytical testing to support pre-CTM to commercial products. Performed testing for raw materials, API’s, and drug products using established proprietary and compendial methods.Evaluated and transferred existing methods into Metrics. Developed and validated new methods for clients including assay, impurities, dissolution, content uniformity, identification, KF moisture, and counterion determination. Produced GMP-compliant laboratory notebooks, data, and reports.Reviewed laboratory notebooks of other analysts.Performed OOS and OOT laboratory investigations.Notable Achievement: Identified the root cause of mysterious peaks observed in company-wide chromatographic analyses to be leaching of compounds from plastic transfer pipets following a recent supplier change.

Columbia, Sc

RESEARCH Thesis: Laser Induced Breakdown Spectroscopy of Aqueous Solutions: Applications and Matrix InterferencesStudied the influence of common inter-element interferences on LIBS and compared the results to established ICP-OES and FAAS methods. (self-directed project)Developed instrumentation and methods for LIBS applicable to quantitative elemental analysis in ice. (self-directed project)Designed and implemented a successful method of internal standards for LIBS of aqueous solutions. (self-directed project)Investigated the effects of LIBS combined with an electric pre-spark for understanding of signal enhancements observed during dual pulse LIBS in solids.Evaluated combinations of dual pulse LIBS using femtosecond and nanosecond laser pulses for understanding of signal enhancements observed during elemental determinations in solids and liquids. (Lawrence Livermore Laboratory, Summer 2003)Co-developed a method for speciation of environmental chromium by LIBS using metal chelating membranes.Provided analytical support for various environmental and engineering research projects with GC-ECD, TOC, and ICP-OESTEACHINGAssisted in instruction of students in Honors General Chemistry, Quantitative Analysis, and Instrumental Analysis. Led laboratory exercises covering fundamentals and application of common instrumentation including: FAES, ICP-OES, UV/Vis, Fluorescence, GC-FID, GC-MS, and HPLC-UV/Vis.Co-authored three laboratory exercises for analytical courses at USC including a forensic application of ICP-OES, the demonstration and reduction of chemical interferences in FAES, and the determination of a solubility product by potentiometric titration. Notable Achievement: Received the Bouknight Teaching Award for Exemplary Performance as a Teaching Assistant.

Wilson, Nc

Fledgling chemist learning basic concepts of quantitative analysis and laboratory documentation in a contract laboratory setting. Prepared samples for and analyzed samples by diverse instrumentation such as HPLC-UV/VIS, KF titration, IC, UV/VIS, TOC, and a C/H/N/O/S elemental analyzer.Prepared assorted environmental, food, cosmetic, tobacco, and pharmaceutical samples with hotplate and microwave digestion procedures. Analyzed samples by traditional FAAS and ICP-OES instrumentation as well as hydride generation and cold vapor Hg sample introduction methods.Executed compendial and proprietary wet chemistry methods for testing raw materials and finished products following GMP guidelines.Allowed to work on Special Projects due to demonstrated proficiency and aptitude.

Doctor Of Philosophy (Ph.D.), Analytical Chemistry

Bachelor'S Degree, Chemistry, Biology

Activities and Societies: Pi Kappa Phi Fraternity

Education record

Education record

Education record