LEAD PRODUCTION SCEINTIST

Molecular biologist with more than six years of experience as a lead production chemist in genomics reagent manufacturing and quality control. Recognized and rewarded as a key contributor in multiple successful product transfers while meeting customer demands with high quality. Demonstrated leadership in troubleshooting processes and delivering results at aggressive schedules. Broad molecular biology skills and experience in protein biochemistry, Laser Capture Micro dissection (LCM) and nucleic acid analysis.

Expertise includes:

• RNA/DNA extractions (cells & FFPE tissues) • PCR, qPCR, RT-PCR

• DNA/RNA purification and amplification • SAP and Oracle

• Vendor qualification • Enzyme validation

• Reagents formulations

PROFESSIONAL EXPERIENCE

LIFE TECHNOLOGIES

Senior Chemist 2010 – March 2012

• Facilitated transfer from Danaher to Life Technology by providing technical input as well as driving the new team setup, product configuration, and workflow. We accomplished smooth transition in record time while maintaining the target inventory levels and customer satisfaction during the transition. Recognized for achieving these results.

• Helped design and execute the qualification plan for validation of enzymes from different vendors, for marketing and product support groups.

• Extracted and stained various tissues using Arcturus Laser Capture Micro dissection (LCM).

• Performed quality control testing for RNA/DNA isolation and amplification kits.

• Extracted RNA from various tissue samples and isolated mRNA from total RNA sample.

• Conducted optimization experiments to discover the longevity of reagent storage and validate new methods of manufacture.

• Quantified and qualified primers, mRNA, Universal human RNA, ffURNA and PCR reagents for use in production.

• Cross-trained other team members.

DANAHER CORPORATION (formerly Molecular Devices) (50,000 employees)

Production Lead 2008-2010

• Supervised a team responsible for planning build size, ordering the material, scheduling, formulating products, testing, QC, and final shipment of 17 different kits.

• Approved and validated the vendor, Duke Empirical for one of our key products in Columns manufacture.

• Planned and adjusted the production schedule according to the forecast and sales history.

• Maintained finished goods inventory and managed backlog.

• Successfully isolated and precipitated TM3 RNA from mouse cell line used for production.

• Designed and implemented changes in standard operating procedures (SOP) to improve both data quality and lab efficiency.

• Wrote and revised batch records, SOP and quality assurance procedures for the manufacturing department.

MOLECULAR DEVICES

Chemist II 2006-2008

• Successfully released the new project XL Modules on an aggressive timeline by redesigning the product line to eliminate QA redundancies and streamline production processes. This resulted in a ~17% reduction, ~ $35,000 in production costs across the entire product line.

• Worked with the R& D team to validate Reverse Transcriptase (RT) enzyme.

• Revised and implemented Manufacturing Operating Procedures (MOP) to improve product quality.

• Worked with the Product Manager and designed the artwork for all new labels.

• Worked with the NPI team to resolve incorrect Bill of Materials BOMs. Revised new BOMs. and replaced wrong part numbers with correct part numbers.

• Wrote packaging MOPs for all new modules.

TECHNICAL SKILLS

RNA/DNA extractions (cells & FFPE tissues), PCR, multiplex RT-PCR, qPCR, T7-based linear DNA/RNA amplification, RNA/DNA Isolations, extractions (cells & FFPE tissues), Tissue Staining and extraction using Laser Capture Micro dissection (LCM) PCR, qPCR. Frozen tissue slide preparation. HPLC.

Genetic transformation, nucleic acid isolation, restriction enzyme analysis, gel electrophoresis, cell culture and DNA sequencing, purification, fragmentation and electrophoretic separation of DNA.

EDUCATION

• M.S. in Biochemistry, San Jose State University, CA

• B.S. in Chemistry and Biology, Kanpur University, India

OTHER SKILLS

Proficient in Microsoft Excel, Word, SAP and Oracle. Experienced in GMP, ISO environment. Familiar with 5S and Kaizen

Contact this candidate