Kenneth Kong
*** ******* ******, ****** ** *****
cell: 415-***-****, email: ************@****.********.***
Professional Summary: Self-starting, hardworking, productive, accurate individual with a
positive attitude. Ten years of experience in the biopharmaceutical industry. Seven years of ISO
9001, ISO13485, cGMP, and pharmacovigilance/drug safety experience as an R&D Chemist &
Failure Analysis Scientist.
EDUCATION: B.A. Molecular & Cell Biology, University of California – Berkeley (2004)
WORK EXPERIENCE:
Bayer Healthcare Pharmaceuticals (Emeryville, California)
Contract Manufacturing Facility – Aseptic Filling Associate (Nov 2012 – Jun 2013)
Ensure current Good Manufacturing Practices
Aseptic gowning up through Class B cleanroom
Prepare cleanroom equipment for product fill inside cleanroom
Review Manufacturing Batch Records (MBR’s)
Review temperature control charts
Print and reconcile final product labels
cGMP final product over-sealing inside cleanroom
Ensure compliance of SOPs are read and trainings/qualifications are diligently completed
Bayer Healthcare Pharmaceuticals (Emeryville, California)
FA Scientist and QA Complaints Coordinator (Aug 2010 –Nov 2012)
Postmarketing surveillance (PMS) investigator of Multiple Sclerosis adverse drug reactions
Postmarketing surveillance (PMS) investigator of Multiple Sclerosis product complaints
Conduct pharmacovigilance failure analysis investigations in BSL-2 lab
Chemical composition analysis by FTIR & SEM
Report monthly metrics to QA/QC management
Assist regulatory audits from FDA, EMEA, Chinese sFDA
Upload FA reports per investigation into Trackwise, forward reports to Regulatory Affairs
Practice pharmacovigilance, compliance, continuous improvements
Performed monthly safety and kaizen 5S audits
Participate in monthly safety meetings
Supported stability studies
QA Complaints Coordinator, record QC sample logs, QA ComLog, update QA Kanban
Diligent in completing Corporate Compliance, cGMP trainings, site safety trainings
Track, update, archive customer complaints and reconcile disposed complaint samples
End of the month sample logbook reviews
End of the month instrument logbook reviews
Review temperature control charts
Apply materials, methods, equipment, environment, personnel investigation methodology to
develop CAPA
Working knowledge of Title 21CFR 210&211, ISO 9001, BSL2 Lab, cGMP, GxP, CAPA, ICH
Scientific liaison for facilitating biologics through U.S. Customs clearance and FDA port holds
Bayer Healthcare Pharmaceuticals (Emeryville, California)
QC Associate Scientist II – Failure Analysis Scientist (Dec 2009 – Jul 2010)
Postmarketing surveillance Hemophilia and Multiple Sclerosis pharmacovigilance investigator
Authored, forwarded FA reports per investigation to Regulatory Affairs, uploaded to Trackwise
Ensure pharmacovigilance, compliance, continuous improvements
Final products/materials analyses utilizing FTIR and SEM
Enter QC sample notebook logs
Corporate Compliance, cGMP trainings, site safety trainings
End of the month sample logbook reviews
Reconcile disposed complaint samples
End of the month instrument logbook reviews
Ensure discrepancies were reported within 24 hours and IRs are created in Trackwise
Performed internal safety audits, kaizen 5s audits, and facilitated with regulatory audits
Supported stability studies, reported monthly metrics to senior management
Initiated change requests(CRs) to move validated lab refrigerators and instruments
Apply materials, methods, equipment, environment, personnel investigation methodology to
develop CAPA
Working knowledge of Title 21CFR 210&211, ISO 9001, BSL2 Lab, cGMP, GxP, CAPA, ICH
Point-of-contact person to liaise complaints/samples through Customs & FDA
Bayer Healthcare Pharmaceuticals (Berkeley, California)
QC Associate Scientist II – Failure Analysis Scientist (Jan 2008 – Dec 2009)
Postmarketing surveillance (PMS) pharmacovigilance ADR investigator
Responsible for investigating Product Technical Complaints & Adverse Events
Hemophilia API, final product, in-process materials, packaging, fibers, Kleen Wipes, stoppers,
glass, metals, and unidentified foreign material analysis by FTIR and SEM
Employ Vernier calipers for dimensional tolerance analysis
Use of stereomicroscopes to assess morphology and elastomeric properties
Authored & forwarded Failure Analysis reports per investigation to Regulatory Affairs and QA
Practice pharmacovigilance, compliance, continuous improvements
Provided support during regulatory audits
Supported stability studies
Enter QC sample notebook logs
Corporate compliance, cGMP trainings, site safety trainings
End of the month instrument logbook reviews
End of the month sample logbook reviews
Reconcile disposed product complaint samples
Review temperature control charts
Initiated change requests(CR) to retire or move validated lab refrigerators and instruments
Ensure discrepancies were reported within 24 hours and IR created in Trackwise
Working knowledge of Title 21CFR 210&211, ISO 9001, BSL2 Lab, cGMP, GxP, CAPA, ICH
Corresponded with U.S. Customs and FDA port authority to clear shipments
Illumina, Inc. (Hayward, California)
QC Associate II – Interim Head of Quality Control (2007 –
Jan 2008)
Analyst, Quality Inspector, Acting Head of Quality Control
Developed RNA, qPCR, NGS assays/methods, SOPs, and Certificates of Quality/Analysis
Managed stability tests, discrepant materials, CAPAs, quality approval, final product release
Bio-Rad Laboratories (Hercules, California)
R&D Chemist I – R&D Chemist II (Oct 2004 – Oct 2006)
Formulation, conjugation, buffer screening studies to develop ELISA assays
Human IgG & IgM antibodies purification, conjugation, fluorescence studies
Completed 200 IVD development experiments/lots for a HTS platform
Completed product technology transfers, scale-ups, stability tests, and assisted in clinical trial
Ran affinity chromatography columns, native & SDS gels, Western blots, HPLC, UV-VIS
Purchased, databased, shipped chemicals, biologics, and raw/in-process materials
Screened reagents, recorded experiments, analyzed statistical data, developed SOPs
Developed autoimmune & infectious diseases ELISA assay calibrators and controls
Weekly presented to VPs, Directors, M.D./scientists, and marketing colleagues
Launched platform BioPlex 2200 w/ FDA 510k clearance and ISO 13485 certification
Applied Biosystems (Foster City, California)
Manufacturing Associate (Jun 2004 - Oct 2004)
Operated automated liquid handling robotics for manufacturing of ABI 1700 human genome
chips/microarrays
Employed state-of-the-science manufacturing/packaging equipment
Performed quality control tests, and FIFO cycle counts
Standard Operating Procedures, ISO, OSHA, GLP
BioEngineering Department (University of California – Berkeley, California)
Research Assistant (Jan 2002-Jun 2003)
Exchanged growth media and managed prevention of embryonic stem cell confluency
Microscopy of cells possessing auto-rhythmic cardiac pattern from post-induced differentiation
Utilized CO2 incubators and Biological Safety Cabinets
Adhered to OSHA and GLP requirements
Solee Inc. (Woodside Apartments – San Jose, California)
Assistant Property Manager (Jan 1997-Aug 2000)
Property Management duties including marketing for new renters, managing renters including
rent collection, amenities maintenance and repair, and general customer service.
Volunteering/Extracurricular: San Francisco Science Fair at AT&T Park – Bayer Booth, Intel
Science & Engineering Fair judge, UC Berkeley - Career Week R&D panelist, UC Berkeley
Alumni Mentor, UC Berkeley Achievements and Leadership Scholarships judge, Hemophilia
Walks, Alameda MS Society Walks, Recently traveled to Asia and Europe.