Director, PDTL Vaccines R&D

• Sep 2022 - Present

Senior Manager

• Jun 2020 - Sep 2022

Veena oversees and provides leadership and technical direction on various aspects of vaccine R&D. Her key responsibilities include:-Lead complex cross-functional teams to assure achievement of project and company goals-Provide scientific expertise and guidance for products and programs including development and execution of technical approaches-Assist in identifying and assessing potential technologies and/or candidates to expand the vaccine portfolio-Collaborate with project managers, function team leaders, senior management, subcontractors, and government funding agencies to ensure integration of project and enterprise goals Show less

Senior Scientist (Vaccines R&D Business Unit)

• Apr 2019 - Jun 2020

Veena worked as a Project Lead for a phase 1 Thermostable vaccine program and also contributed across several other vaccine programs with her scientific expertise. The following are the highlights of her contributions: -Evaluation of safety and efficacy/immunogenicity of vaccine candidates-Using project management best practices, create and implement project plans, timelines, and budgets -Identification, assessment and management of project risks -Manage technical, business, and contractual relationships with vendors, consultants, and government clients-Leads project team activities-Experience in authoring and reviewing eCTD* CMC* sections in a BLA* submission-Experience in authoring eCTD* sections and managing workflows within a DMF* submission for IND**CMC-Chemistry Manufacturing and Controls; BLA-Biologics License Application; DMF-Drug Master File; IND-Investigational New Drug; eCTD-electronic Common Technical Document Show less

Scientist (Formulation Development)

• Jan 2018 - Apr 2019

Veena's key contributions include the following in addition to other peripheral responsibilities to support R&D activities of Phase I and III drug product development at Emergent:-Develop study design for assay validation for Phase III clinical trial product release-Develop Fit-for-use assay qualification study design and manage execution for late phase drug product-Manage GMP Tech Transfer activities between Emergent and Contract Manufacturing Organizations (CMOs) for manufacturing of critical agent-Manage Sample and Inventory of Phase I early development and Phase III clinical trial drug product for stability studies-Manage stability or thermal stress studies programs of Phase I and Phase III drug product. Assign analysts and manage data for such studies.-Interface between R&D and Manufacturing group for overall product development using LIMS system-Subject Matter Expert in Zeta Potential, Particle Size Distribution and Gel Volume assays for adjuvant vaccines -Perform data analysis using JMP and GraphPad Prism -Write protocols, batch records for development and validation work, technical reports, BARDA monthly and annual reports, standard operating procedures and test methods for Phase III drug product-Write SAP change control plan and closure, deviations report for any discrepancies that occur during execution of protocols-Support QA in generating Specification, CoA (new and retest) and disposition documents for release of critical reagents. Show less

Associate Scientist II (Formulation Development)

• Dec 2015 - Jan 2018

Veena joined Emergent BioSolutions as an Associate Scientist in the Formulation Development division, and supports R&D activities in several NIAID and BARDA contract projects. Her key roles include: •Supporting physicochemical stability testing of newly developed biodefense vaccine lots for R&D and clinical vaccine samples•Down-selection of manufacturing process and GMP-feasible formulation procedures for large scale production of newly developed biodefense vaccine formulations•Leading particle size assay and supporting zeta potential and gel height assay qualification development to characterize historical lots of biodefense vaccine formulations•Leading the formulation development team in inventory management and keeping abreast with equipment calibration and maintenance Show less

Faculty Research Engineer

• Feb 2014 - Jun 2016

Veena Rao joined CEEE as a Faculty Research Engineer shortly after graduating at UMD with a Master of Science degree. At the center's S2TS lab, Ms. Rao prepared federal and industrial research proposals for the S2TS lab, and coordinated lab-related activities. Ms. Rao also has expertise in building energy audit research work and advised students on how to conduct ASHRAE energy audits of UMD buildings in order to significantly improve energy efficiency. She was also the chief web designer and manager of the research lab webpage www.s2ts.umd.edu. Show less

Graduate Teaching Assistant

• Jan 2013 - Dec 2013

Veena instructed sophomores in Engineering and held discussions to clarify concepts and improved their problem solving skills

Graduate Research Assistant

• Jan 2012 - Dec 2013

During Masters program, Veena conducted her research thesis on surfactants at Complex Fluids and nanomaterials laboratory in Chemical Engineering Department and performed cytotoxicity studies on surfactant vesicles in Fischell Department of BioEngineering.

Process Manager

• Sep 2008 - Sep 2009

Veena was offered Process Manager position by India's giant petrochemical industry-Reliance Industries soon after she completed her Bachelors degree in Chemical Engineering from University of Mumbai. Veena supervised technicians, planned, executed and handled several projects through her key roles as described in the project section. Veena was offered Process Manager position by India's giant petrochemical industry-Reliance Industries soon after she completed her Bachelors degree in Chemical Engineering from University of Mumbai. Veena supervised technicians, planned, executed and handled several projects through her key roles as described in the project section.

Undergraduate Research Assistant

• Jul 2007 - Jun 2008

Ms. Rao worked at Advanced Chemistry Lab at University of Mumbai during her Bachelor's degree. Her research group performed in-depth analysis of heat extraction process that was engaged in extracting Pectin (fruit juice stabilizer) from natural citric based fruit sources. Veena and her team were then involved in scaling up studies and cost analysis for the pilot scale process design for extracting pectin. Ms. Rao worked at Advanced Chemistry Lab at University of Mumbai during her Bachelor's degree. Her research group performed in-depth analysis of heat extraction process that was engaged in extracting Pectin (fruit juice stabilizer) from natural citric based fruit sources. Veena and her team were then involved in scaling up studies and cost analysis for the pilot scale process design for extracting pectin.

Process Engineer Intern

• May 2007 - Aug 2007

Veena joined Galaxy Surfactants as a process intern during her Bachelors degree to gain an insight on the process production operations. Veena joined Galaxy Surfactants as a process intern during her Bachelors degree to gain an insight on the process production operations.