1. JANET WILLIS
2752 Ariane Drive Unit 112, San Diego, California 92117
E-mail: janet.willis101@gmail.com
www.linkedin.com/in/willisjanet
(858) 483-7542 • Cell: (619) 321-8535
EDUCATION
 University of California San Diego B.S. Chemistry 2012
 Agilent Dissolution one-one online course with certificate In-Process
 ACCTA Web-Based Training Completed
(Chemstation basics)
 ACCTA Web-Based Training In-Process
(Chemstation method editing and sample runs)
PUBLICATIONS
 Perrin, C. ,Chang, K. J. Org. Chem. 2016, 81, 5631- 5635
WORK EXPERIENCE
Research Associate, Jansen (Johnson and Johnson) through Kelly OCG (June-2016 –
Sept 2016)
• Run equilibrium solubility (shake flask method) analysis for pipeline products via
HPLC (Chemstation software)
• 96 well format sample preparation
Chemist/Validation Scientist, Intertek Pharmaceutical Services (September 2015 – June
2016)
• Draft and design method transfer/partial validation plans and full validation plans
for testing of GLP and clinical study samples containing small molecule analytes.

2. Janet Willis
• 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.
• Troubleshoot HPLC-Mass spectrometry methods developed in house for current
and future analysis of small molecules used in clinical and GLP study samples.
• Troubleshoot extraction procedures such as SPE (solid phase extraction) and PPE
(Protein Precipitation extraction). 96 well and individual sample formats.
• 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 practices.
• Review run data and assess/approve runs based on chromatography quality and
acceptability.
Quality Assurance Associate, Intertek Pharmaceutical Services
(May 2013-September 2015)
 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.
 Responsible for assuring 21 CFR Part 11 Electronic Records and Signature
regulations are being followed for automated data collection systems.
 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,
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3. Janet Willis
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.
Quality Control Lead Analyst, VBC
(2012-2013)
 Re-built a quality control lab for a re-start up CMO (Contract Manufacturing
Organization) for testing of fermentation products and raw material testing per
GMP and USP guidance.
 Main emphasis on process and method development for raw material testing
according to US Pharmacopeia using immunoassay methods such as ELISA, and
analytical methods such as HPLC (IEC and SEC), GC, UV-Vis and capillary
electrophoresis.
 Daily activities 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
API.
 Familiar with production of biological API : ultrafiltration (TFF), fermentation
media components and parameters (Dissolved Oxygen, viablilty 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.
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4. Janet Willis
Student, Undergraduate Researcher, UCSD Department of Chemistry and
Biochemistry
(2010 – 2012)
• Investigated pseudo-first order reaction kinetics involving base catalyzed
hydrolysis for research publication; used UV-VIS, IR, Computational Software.
• Utilized various methods of purification such as vacuum distillation, freezing
point depression, and thin-layer chromatography.
• Completed graduate level course on applied x-ray crystallography where
assignments involved identifying real crystal structures.
• Presented undergraduate research two years in a row at the UCSD annual
Undergraduate Research Conference.
Research Assistant (Contractor), Amylin Pharmaceuticals
(2008 – 2009)
• Assisted on various cloning projects for developing new protein product pipeline.
• Performed PCR/RT PCR (especially in conjunction with de novo sequencing in
house), protein conjugation, gravity flow affinity purification of protein fragments
(peptides and polypeptides) of interest, expression of those fragments in bacterial
cells, SDS PAGE analysis, and agarose gel analysis.
• Analyzed sequencing data using Align X® and Vector NTI ®software.
• Utilized Solexa and HiSeq instrumentation.
• Oversaw glassware cleaning and autoclaving for molecular biology and chemistry
departments.
• Wrote and revised methods and SOP’s.
Laboratory Assistant (Contractor), DOW Chemical Company
(2007 )
• Assisted in method development of high throughput cell lysis system including
multiple probe sonication unit development and alternate non-chemical based cell
lysis methods for 96 well sample format.
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5. Janet Willis
• Performed SDS PAGE and Western Blot methods, AKTA FPLC on various
protein products produced by fermentation, performed general buffer and sample
preparation for the analytical chemistry group.
• Managed laboratory for the analytical chemistry group.
Manufacturing/Process Chemist (Contractor), Genentech
(2006 – 2007)
• Monitored automated processes via computer system for the fermentation group.
• Worked in glass wash for both the formulation and fermentation groups.
• Acquired experience working in a GMP clean room environment.
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6. Janet Willis
Scientific Intern and Lab Manager, The Scripps Research Institute, La Jolla
(2002 – 2006)
• Assisted in the following areas of research in the Department of Cell Biology:
structural elucidation of nuclear porin proteins via X-ray Crystallography;
recombinant DNA techniques; protein conjugation; FPLC (AKTA) and HPLC
protein purificaton, fluorimetry and UV-Vis spectrometry; affinity gravity
filtration purification of proteins and DNA; cell culture work; and
implementation of various standard protein and DNA analytical methods.
• Acted as lab manager ordering supplies and reagents, preparing buffers and stock
reagents, incubator and cell culture area maintenance, organizing cell and DNA
freezer stocks.
Chemistry, Biology, and Math Tutor/TA, Cuyamaca College
(2000 – 2006)
• Worked as tutor and teaching assistant in the Learning Skills/Tutoring Center in
the Department of Science and Engineering
• Assisted students one-on-one and in study groups with all levels of chemistry,
some biology and calculus based math courses.
AWARDS AND SCHOLARSHIPS, PROFESSIONAL AFFILIATIONS
• Undergraduate Research Conference participation certificate, University of
California San Diego, 2011
• Chancellor’s Research Scholarship, University of California San Diego, 2010,
$3000
COMPUTER PROFICIENCY
• Microsoft Office: Word, Excel, PowerPoint, Outlook
• Laboratory/Analytical Software: WinKQCL™, OMNIC, Vector NTI®, Align
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7. Janet Willis
X®, Gaussian, Softmax Pro®, Agilent 2100 Expert software, Watson LIMS,
ALISIC, Agilent Chromeleon, Agilent Chemstation, Analyst
REGULATORY
• Working knowledge of current US Pharmacopeia guidelines
• Attended multiple training sessions in the Food and Drug Administration Good
Laboratory Practice, Good Clinical Practices, and Good Manufacturing Practices
regulations; and 21 CFR Part 11 Electronic Records and Signatures
• Familiar with Organization for Economic Cooperation and Development Good
Laboratory Practices and associated guidelines
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