SUMMARY

• Scientist with experienced in quantitative and qualitative assays for small and large molecules, characterization of new drug product, purity test assay using analytical chromatographic method, wet analytical assay, microbiological assay using aseptic technique, method development and validation based on USP, EP, ISO and ICH guidelines in Biotech, Pharmaceutical and CRO cGMP environment.
• Hands on CMC technical writer with expertise in authoring scientific reports for method remediation (CMC), regulatory documentations, laboratory protocol / SOP and instruction manuals in Biotech, Pharmaceutical, Biopharmaceutical and CRO organization.

TECHNICAL SKILLS

ANALYTICAL CHEMISTRY: Method Development & Optimization, Method Validation

BIOCHEMISTRY / BIOLOGICAL ASSAY: Antibody Purification, Conjugation, Hybridization, ELISA, SDS Page / Electrophoresis, Densitometer, PCR, DNA Sequencer, Agilent Bioanalyzer, Aseptic Technique

CHROMATOGRAPHIC TECHNIQUES: Anion Exchange, Reverse Phase, Affinity, Size Exclusion (SEC)

INSTRUMENTATION: HPLC, LC/MS - ESI, FPLC, GC (Agilent’s 5890 Series II), IR, Fluorescence, UV Spectrophotometer, Karl Fischer Titrator

SOFTWARE: ChemStation, Empower, Chromeleon, Beckman’s 32 Karat, GE Akta Unicorn 5.11, LIMS, Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat)

PROFESSIONAL EXPERIENCE

Auditor

Confidential

Responsibilities:

• Mayan ruins in Mexico and Angkor Wat ruins in Cambodia
• Phuket Province, Thailand
• Manila and other coastal cities, Philippines.
• Volunteer at the Braille Institute for the Blind in La Jolla California.

Scientist / CMC Technical Writer

Confidential, Irvine, CA

Responsibilities:

• Developed and optimized analytical HPLC method for small molecule. Performed quantitative test assay on the submitted small molecule samples using chromatographic techniques. Carried out post data evaluation and troubleshoot related issue.
• Authored final technical reports for method remediation (CMC) in pharmaceutical environment using expertise with advance scientific practices and principles, from raw and/or processed data. Prepared and authored reports for stability, release, compatibility, method development, method validation and protocols using USP, EP and ICH guidelines in pharmaceutical, biopharma and CRO environment. Drafted, edited and rewritten project designated scientific documents for clients and other cross functional groups.
• Collaborated with scientist and other scientific personnel for data accuracy, consistency and compliance with scientific report writing guidelines.
• Articulately presented and assembled raw data in tabulated format and graphs. Data, chromatograms and graphs are incorporated to reports.
• Prepared Laboratory Deviation Reports and assisted in the preparation of OOS, LIR and CAPA.
• Developed specified formats/templates as required and in compliance with document control procedures.

CMC Technical Writer

Confidential

Responsibilities:

• Authored method SOP’s based on USP, EP and ICH guidelines, USP Verification Protocols and Reports, Method Transfer Protocols, and Method Transfer Reports for Commercial and Non Commercial Products.
• Prepared Laboratory Deviation Reports and assisted in the preparation of OOS and LIR.
• Trained and coordinated with CRO’s, laboratory personnel for the method transfer program.
• Reviewed method validation and transfer data from CRO’s, Scientific Affairs and QC analytical services.
• Harmonized USP and EP methods.

Biological Scientist

Confidential

Responsibilities:

• Developed and optimized analytical HPLC method. Performed solid support evaluation using DNA and siRNA synthesis platform. Carried out post synthesis evaluation and determined the full length purity of the crude oligonucleotide using analytical HPLC. Troubleshoot synthesis related issue. Analyzed and interpreted mass spec result on complex samples. Performed maintenance, calibration and troubleshooting on laboratory instruments. Prepared SOP’s, protocols and in house documentations.
• Performed stability studies on solid support using DNA and siRNA synthesis. Evaluated, summarized and presented data results.

Sr. Research Associate

Confidential

Responsibilities:

• Developed and performed quantitative test method for the identity and purity of oligonucleotides, pRNA’s, dNTP, peptides, antibodies, conjugated antibodies, hybridized antibodies with pRNA / FAM / FITC and the concentration of Tris(2-carboxyethyl) phosphine (TCEP) from lyophilized TCEP beads using analytical chromatographic techniques. Prepared amplicon test solution using PCR and consequently carried out amplicon contamination determination in the clean room and other work environment. Evaluated amplicon environmental samples using Agilent Bioanalyzer.
• Performed method validation and system qualification using USP and ICH guidelines.
• Carried out bench experimental conjugation and hybridization. Performed stability test on shelf life samples. Analyzed and interpreted mass spec result from outsource laboratories on the submitted complex samples. Performed maintenance, calibration and troubleshooting on different HPLC systems and other analytical laboratory instruments.
• Archived test results and organized retention samples into library database. Prepared SOP’s and in-house documentations.
• Performed synthesis on custom oligonucleotides using ABI 3900 and Expedite synthesis instruments. Purified HRP, AP conjugates and crude oligonucleotides using perfusion chromatography and HPLC. Prepared volumetric solutions for DNA / RNA synthesis.