Janet Willis Email & Phone Number

San Diego, CA, US

Validation specialist dealing with small and large molecule analytical methods. Over 15 years experience from everything LCMS, HPLC, FTIR, NMR; 21CFR Part 58, 11; and GXP policies and procedures including data review, internal auditing, report writing. I have done method transfer, statistical analysis, dealt with clients, been in FDA and client audits to.

San Diego, California, US

Brought on to help with validation runs for an FDA submission.HAACP certification required and received. Process validation of process gas systems and CIP skid water testing, analysis ( sampling, titration, hardness/alkaline testing and microbial analysis) and report writing. Intiated SOPs for plant temperature and humidity monitoring, NIST certified.

Gaithersburg, Maryland, US

Manager of environmental monitoring (EM) for postproduction (personnel monitoring and room sampling) and room release, as well as overseeing routine EM performed by outside contractors. Duties involve writing deviations, including CAPA and effectiveness checks, excursion reports and quarterly EM trend reports, coordinating with Clinical Manufacturing.

San Diego, CA, US

In the Cole lab working on the Chan-Lam reaction of various alkyl and alkenyl boronic acids to potential drug candidate functional groups such as sulfonamides and various aniline adducts; The reaction is similar to a Buchwald-Hartwig or Suzuki coupling reaction of copper-akyl and alkenyl complexes. involved the use of: GC, NMR (C13 and H1), TLC (Thin Layer.

Raritan, New Jersey, US

Run equilibrium solubility (shake flask method) analysis for pipeline products via HPLC (Chemstation software)96 well format sample preparation

London, GB

Draft and design method transfer/partial validation plans and full validation plans for testing of GLP and clinical study samples containing small molecule analytes. Draft, review, and/or approve bioanalytical procedures for validation and sample analysis for accuracy, scientific validity and regulatory compliance (GLP or ICH guidelines) where required..

London, GB

Responsible for performing in-process, raw data and final report audits according to GLP and GCP regulations, protocols, bioanalytical procedures, client proprietary and internal SOPs. Projects inspected and audited include the development, validation and sample analysis of proprietary assays, existing methods and immunoassay kits (ELISA and ECL platforms).

Re-built a quality control lab for a re-start up CMO (Contract Manufacturing Organization) for testing of fermentation products (monoclonal antibodies and protein conjugates) and raw material testing per GMP and USP guidance. Main emphasis on application of analytical methods for testing in-process and purified API’s (fusion/conjugate proteins and.

La Jolla, CA, US

• Investigating pseudo-first order reaction kinetics involving base catalyzed hydrolysis for purpose of publication- UV-VIS, IR, Computational Software.
• Utilized various methods of purification such as vacuum distillation, freezing point depression, and thin-layer chromatography.
• Completed a graduate level course on applied x-ray crystallography in which real crystal structures were actually solved as assignments.
• Presented undergraduate research two years in a row at the UCSD annual Undergraduate Research Conference.

La Jolla, California, US

• Areas of Research: structural elucidation of nuclear porin proteins via X-ray Crystallography, recombinant DNA techniques, purification of proteins and DNA, cell culture work, and implementation of various standard.
• Also acted as long running lab manager ordering supplies/reagents, preparing buffers and stock reagents, incubator and cell culture area maintenance, organizing cell and DNA freezer stocks.

Bachelor Of Science (Bs), Organic Chemistry

Master Of Science - Ms, Organic Chemistry/Synthetic

Completed Transfer Requirements For Ucsd, Chemistry

Bachelor'S Degree, Organic Chemistry