Janet Willis Email & Phone Number

San Diego, Ca, Us

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 name a few.

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 equipment SOPs, and metal detector SOP for pilot plant production. Reviewed batch records for adherence to cGMP and for proper documentation practices. Wrote work instructions and forms for various processes.

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, facilities, materials management, and Quality Assurance. Inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods (FTIR and wet chemistry) and standard test methods (osmolality, appearance, pH, Conductivity) for stability study samples. Revising/writing raw material specifications. GXP environment including documentation (GDP), GMP standards (guided by SOPs and Raw Material specifications, reviewing OOS reports, revising SOPs and raw material specifications). Oversee equipment calibration with VCM (Validation Calibration and Maintenance) as well as out of service and return to service status.

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 Chromatography), FTIR, normal phase silica column chromatography.

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. Assist project management in organizing and preparing validation reagents and documents as well as assisting in the management of extraction chemists running the validations or analysis. Drafting final validation reports. Build validation and sample analysis runs in the LIMS system for extraction chemists and coordinate workflow with LCMS operators. Assist in management of project inventory (control matrices, control solutions, neat reference substances, standards solutions, etc.) Review run paperwork for completion, deviations to method and SOPs and good documentation (GDP) practices in a GLP environment. Review run data and assess/approve runs based on chromatography quality and acceptability.

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) in support of clinical and preclinical studies measuring therapeutic drugs, synthetic proteins, humanized monoclonal antibodies, chimerics, conjugated drugs, growth factors, hormones, cytokines and biomarkers. Interact with clients, project managers, coordinators and analysts to assure accurate reporting and interpretation of raw data for regulatory submission.

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 monoclonal antibodies) via immunoassay methods such as ELISA, and analytical methods such as HPLC (IEC and affinity), UV-Vis, SDS PAGE and capillary electrophoresis. Develop and incorporate raw material testing according to US Pharmacopeia identity tests often coupled with FTIR analysis. Perform stability studies on bulk materials and intermediates. Daily activities typically involved in process and final lot release testing including but not limited to endotoxin testing, sterility testing, purity testing, and small- scale affinity chromatography for human IgG purification and other large molecule APIs.Familiar with production of biological API: fermentation media components and parameters (Dissolved Oxygen, viability analysis, pH, media components and their uses, and determination of cell culture feeding) Experience included implementing GMP standards in the R & D laboratory including generation of applicable SOPs. Maintained records of data, sample identification and tracking, and an accurate and up-to-date inventory of test and retention samples, testing reagents/kits, and equipment. Performed routine environmental monitoring of clean room areas in order to maintain certified ISO classification. Instituted preventive maintenance schedule for analytical equipment. Performed routine equipment maintenance; instituted and maintained GMP compliant equipment maintenance records.

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 protein and DNA analytical methods.• 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