Kenneth Kong

*** ******* ******, ****** ** *****

cell: 415-***-****, email: acdrqt@r.postjobfree.com

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.

Contact this candidate