Close Close Preview

Your amazing online presence is right this way.

Create your profile
Capture who you are, what you do, and where you're going. All in one place.

Toya Kimble

Toya Kimble

Biopharma Product Development Scientist | Project Manager

Currently Seeking New Position as Project Leader

memphis, Other

PROJECT MANAGER| BIOPHARMA| PRODUCT DEVELOPMENT SCIENTIST Seeking New Project Lead Role in Pharma or Device Development

Message
MENU ☰

Currently Seeking New Position as Project Leader

Biopharma Product Development Scientist | Project Manager

Eager to discuss opportunities that will take full advantage of my broad and diverse experience in pharmaceutical product development:

-project management
-non-clinical toxicology/safety
-non-clinical study management

What do I bring to the table?

-strong leadership skills!
-ability to influence and work across cross-functional networks!
-smooth adaptability in changing business environment!
-positive, dynamic, creative, and resourceful personality!

Career medium 04
Career
Career medium 01

Medtronic Spinal and Biologics

Sr. Scientist

Project lead with 13-member cross-functional team for the development and implementation of pharma/combination product development and commercialization

•Developed stage-gated mapping of specific cross-functional activities and deliverables from concept to commercialization
•Implemented pharma product development process framework and guidance document
•Implemented new SOP’s and work instructions into Quality System
•Incorporated device design control process for combination product development
•Developed training material and conducted training for project and functional teams

Led and contributed to key scientific initiatives for new product development (musculoskeletal and neurodegenerative diseases, neurotrauma, and pain); Applied technical experience for new product development opportunities

Led pre-clinical and safety/toxicological evaluation of pharma products in development (non and GLP); Interpreted scientific data, prepared non-clinical summaries and presentations for regulatory submissions; Proposed clinical safety outcomes based on non-clinical data

•Led early product development activities and execution for 2 projects; Accountable for technical assessment and review of competitive landscape; animal model development, feasibility study design, data evaluation, and risk assessment

•Led safety/tox subteam for 3 high-visibility programs; Accountable for strategy and timelines; management of multi-site CRO studies, design, protocols, reports, relationships, contracts, scheduling, budget

•Evaluated and interpreted scientific and safety data, prepared non-clinical summaries and presentations for pre-IND, IND submissions, FDA meetings

•Prepared responses for FDA questions/feedback

•Strong knowledge of cGLP; cGMP; ICH Q8, 9, 10; Design Controls

Career

University of Tennessee Health Science Center

Postdoctoral Student

Basic research on the neural control of choroidal blood flow; effect on retinal health when there is a defect in the normal vasodilatory response of the choroid.

Career medium 03
Career

University of Tennessee-Health Science Center

Ph.D., Neuroscience

Christian Brothers University

BS, Biology