Process Development
Resume:
Nikhita Tandon
San Jose, CA *****
*******.********@*****.***
OBJECTIVE
Seeking a Research Associate/Biochemist position with a Biotechnology firm focusing on scientific research and Process Development
QUALIFICATIONS/KEY ACCOMPLISHMENTS
• B.S. Chemistry, Concentration in Biochemistry, San Jose State University, San Jose CA (Aug’07- Dec’11)
LABORATORY TECHNIQUES/SKILLS
• Gained over 3 years of research experience as a team lead in designing and executing small-scale experiments to optimize & characterize protein/enzyme purification processes. Proficient in HPLC, RP-HPLC, GC/MS, GC-NMR, IR and UV-Vis
Spectrometers.
• Gained expertise in protein separation techniques: Affinity, Size exclusion Chromatography & protein characterization using Mass Spectroscopy and Bradford assay.
• Conducted over 2 years of research using a variety of techniques: Primer design, Site-directed mutagenesis, bacterial transformation, SDS-PAGE and PCR cloning; Basic knowledge of SOUTHERN/WESTERN BLOTTING.
• Prepared assay qualification/validation reports, sample testing reports; Implemented strong knowledge of GMP in Scientific lab reports and validating activities.
• Gained hands on experience with Buffer preparation and reagents testing; Equipment monitoring- Glasswashers, Mixing tanks, Osmometers and Autoclaves and filtration assemblies.
• Basic knowledge of protein formulation, Bacterial/Mammalian cell culturing, Colony Isolation/Staining Procedures
using ASEPTIC techniques.
EXPERIENCE (INTERESTING PROJECTS)
PURIFICATION DEVELOPMENT ASSOCIATE II- NOVARTIS VACCINES AND DIAGNOSTICS (FEB’12 - PRESENT)
• Worked with post-doctoral scientists, QA approvers and site quality heads to provide technical oversight for historical data analysis, criticality assessments for process parameters, and FMEA analysis.
• Assist in the development of quantitative Sodium Dodecyl Sulfate - Polyacrylamide Gel Electrophoresis (SDS-PAGE) assays for determining antigenic titers; fraction pooling to determine critical process paramenters (CPPs) for process robustness in PAR reports.
• Hands on experience working with BIO-RAD's Gel Doc Stain Free system and analytical modules such as Image Lab.
• Gained expertise in writing deviation reports, associated CAPAs, product impact assessments and risk assessments.
• Researched and wrote DR/CAPA implementation report for assessing the criticality of carbamylation with respect to both IEC in process yield and % monomer bulk release failure in the production of HCV c100-3 bulk antigen production process; obtained approval of QA approver and Principal Scientists.
• Performed column packing for purification of HCV antigens c100 and HCr43 using affinity chromatography, downstream processing using GFC and HPLC testing with adherence to SOPs.
• Performed several Audits for critical PAR reports, DR/CAPA, Manufacturing and Validation reports in compliance with SOPs; for the purpose of FDA inspection.
RESEARCH ASSOCIATE – SAN JOSE STATE UNIVERSITY (MAY 09 -DEC’11)
• Quantitative Validation of RP-HPLC for separation of 5 simple Bromophenols.
• RP-HPLC/UV method was validated in terms of limit of detection (LOD), limit of quantification (LOQ), linearity and precision.
• Utilized Gradient/ Isocratic elution tested at different wavelengths allowed for shortening the analysis time and also enhance the detection conditions.
• Created independent, creative & an established record of research results to perform troubleshooting of experimental procedures.
• Prepared and edited validation reports and general communications for supervisor review.
KEY ACHIEVEMENTS
• Made accurate & reliable scientific contributions to the biotech industry with self- troubleshooting experimentation strategies.
• Addressed in the Dean’s List of Honors for four consecutive semesters (Spring’08- 10)
• Outstanding Performance Certification in PTK (Phi Theta Kappa) Chapter.
• Received Departmental Honors Certification with the National Society of Leadership and Success (NSLS) for maintaining a consistent GPA of 3.50 in the Junior and Senior years.
SPECIAL SKILLS
• Professional demeanor with excellent experience with public speaking, including voice and dialogue training.
• Ability to work independently, multitask and prioritize essential reasoning and analytical skills.
• Strong ability to work in teams and collaborations; Proficient with Word, PowerPoint, Excel.
Contact this candidate