Oragenics, Inc. Work Values

Daily Duties at Oragenics, Inc.:

Developed clinical and regulatory strategy for company’s SMART genetically modified live bacterial vaccine for the prevention of tooth decay. Managed technical transfer and outsourcing to CRLs, CROs, and CMOs for cGxP performance of production processes, lot release, stability programs, and PK/ADME Tox and clinical programs. Developed process for manufacture of live genetically engineered bacterial vaccine in bulk and formulation to allow distribution of product in freeze-dried formulation. Created validated analytical methods to verify the identity, purity, and potency of SMaRT vaccine product. Designed validated analytical methodologies to track by genetic identity transmissibility of SMaRT vaccine organism. Moved SMaRT vaccine product off of two-year clinical hold and into clinic. • Produced fermentation-based and synthetic-based processes for production of Lantibiotic MU 1140 product produced by S. mutans. • Developed validated analytical methods to verify identity, purity, and potency of MU 1140 product. • Created validated Mass Spectrometric methodologies (LC/MS/MS) to detect MU 1140 product in support of animal PK studies. • Produced analytical methodologies for physical characterization of the MU 1140 products. • Designed mass spectrophotometric and “wet chemical” analytical methodologies to support company and small molecule drug candidate for treatment of obesity. • Identified and assessed potential partners for out-license or partnering of company’s products. Note: Company was in financial distress due to a loss of a partnering deal when I left. At the time I was being paid in future stock grants in lieu of salary.

What they like about Oragenics, Inc.:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Project Management, Program Management, CMC Team Leadership, Stratgegy, Cross Functional Team Leadership, Product Development, Market Analytics, Commercial Forecasting, Supply Chain Management, Quality by Design, Six Sigma Black Belt, Enteprise Microsoft Project, Sharepoint

Skills

Project Management, Program Management, Cross Functional Team Leadership, CMC Team Leadership, Clinical Team Leadership, Quality by Design Drug Development, Six Sigma Black Belt, Analytical Methods Development / Validation, Bioanalytical Methods Development , Cell Base Bioassay Development \ Validation, CMC Technical Transfer, Manufacturing Process Characterization, PK/ADME, Market Analysis, Commercial Forecast, Supply Chain Management, Quality Management, Risk Management, Risk Management, Clinical Project Management, Validation Manufacturing Processes

These are some of the questions we asked our climbers about their experiences with Oragenics, Inc.: