Scientist / Technical Writer Resume Irvine, CA - Hire IT People

PROFILE:

Hands on technical writer with expertise in authoring scientific reports for method remediation (CMC), regulatory documentations, laboratory protocol / SOP and instruction manuals in Confidential, Pharmaceutical, Biopharmaceutical and CRO organization.
Motivated research and development professional with experience in protein purification, wet analytical assays, method development and validation, quantitative and qualitative assays using USP, EP and ICH guidelines in the Confidential and Pharmaceutical industry.

SOFTWARE:

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

WORK EXPERIENCE CHRONOLOGY:

Scientist / Technical Writer

Confidential, Irvine, CA

Responsibilities:

Carried out quantitative test assay on submitted samples for small molecules using chromatographic techniques.
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.
Developed specified formats/templates as required and in compliance with document control procedures.
Reviewed submitted scientific data for data accuracy and consistency.

CMC Technical Writer - R&D / QC Analytical Services

Confidential, Irvine, CA

Responsibilities:

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, Oceanside, CA

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 - Analytical Chemistry

Confidential, San Diego, CA

Responsibilities:

Developed 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.
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.

Chemist - DNA / RNA Synthesis and Purification

Confidential, San Diego, CA

Responsibilities:

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.

Associate Process Chemist

Confidential, San Diego, CA

Responsibilities:

Carried out purification processes on various Confidential antibodies using gel filtration and affinity chromatographic techniques.
Improved and troubleshoot anti-alpha Confidential purification.
Performed conjugate processes for dipstick and other test kit products.
Monitored the quality of the processed purified antibodies by Electrophoresis / SDS page and Densitometer.
Performed antibody screening using ELISA.