Vibha Gupta Email & Phone Number

Rockville, MD

Rockville, MD

• Primarily responsible for managing the process of releasing product including scheduling of testing, evaluation of batch records and product disposition. Responsible for managing deviations and NCMRs as required for.
• Responsible for supporting, mentoring and documenting performance evaluation of the direct reports. Responsible for creating training presentations and revising documents and analysis templates as necessary..

Germantown, MD

• Actively involved in staff and lab management for various R&D projects that involves resource allocation, priority determination and binder creation for QA review.
• Present monthly status updates and final reports to upper management.
• Project Lead on several V&V activities for CE mark and FDA submission for QuantiFERON technology advancement.
• Actively involved with internal QC data analysis for determining areas of improvement to alleviate customer complaints in the field for the currently sold products.
• Feasibility studies management for evaluation of the ELISA automated platforms and optimization for commercialization.
• Manage projects; coordinate with external and internal sites, and perform planning activities for R&D for timely delivery of the project.

Gaithersburg

• Developed and implemented novel assays on high through-put platforms approved for effective commercialization to increase company revenue.
• Designed experiments, analyzed and interpreted experimental results to optimize assays.
• Transferred product from R&D to commercial manufacturing for PCR based assay.
• Accountable for documentation, vendor identification, ordering, inventory, verification lot production, QC / Quality Control, specification determination, kit configuration and coordination with customers.
• Established QC methods for in-coming raw materials and identified secondary vendors.
• Concluded statistical data analysis for studies such as specification determination and Guardbanding.

Germantown

• Lab Manager for Implemented the 5S initiative (Laboratory Compliance)
• Managing Pilot Plant Stock Room
• Lead role in creating a more practical work environment for lab organization.
• Managing maintenance and calibration of laboratory equipments.
• Managed Goat Program
• Supervising Junior Scientists to perform testing of Goat Serum bleeds.

Gaithersburg

• Optimized, prepared, and tested reagents for Cervical Cancer diagnostic kit, increasing sensitivity of assay.
• Saved 2 days and $20K per production by contributing to bulk manufacturing process scale up, validation, and transfer from laboratory to production.
• Performed conjugation and process optimization for purification of monoclonal antibody and enzyme using LC (SEC and IEC columns).
• Improved conjugation reaction by analyzing conjugates on Reverse Phase HPLC.
• Ensured proper documentation by preparing SOPs, MMR, raw material specifications sheets and technical reports.
• Designed experiments to study the optimized conjugates by analyzing study data using statistical software such as MS Excel and JMP.

Extremely articulate, multidimensional Manufacturing Scientist who collaborates very effectively with cross functional teams to meet tight deadlines. Team player with strong business acumen who has thorough understanding of corporate strategy and driven to meet individual as well as company's goals. Recognized by senior management for outstanding.

Columbia, SC

• Established native Escherichia coli SufA, coexpressed with SufBCDSE, purifies as [2Fe-2S] protein and acts as Fe-S transporter to Fe-S target enzymes.
• Discovered SufD protein was essential for survival of E.Coli in oxidative stress and iron starvation.
• Performed protein purification using liquid chromatography and hydrophobic interactions, size exclusion and ion exchange columns, and protease digestion for peptide analysis by mass spectrometry.
• Performed Kinetic assays to study ATPase and Desulfurase activities.
• Characterized protein using UV-Vis and Mössbauer spectroscopy.
• Studied protein-protein interactions, using SPR and western blotting.

Ms, Biochemistry

Bachelor'S In Science Degree, Medicine