Senior Microbiologist position vacant @ CareFusion II PhD candidates apply II

About the Company:

CareFusion is a global corporation serving the health care industry with products and services that help improve the cost and safety of health care for generations to come. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife™ and LTV® series ventilation and respiratory products, ChloraPrep® skin preparation products, MedMined™ services for data mining surveillance, NeuroCare neurological monitoring and diagnostic products, V. Mueller® surgical Instruments and an extensive line of products that support interventional medicine. CareFusion employs more than 14,000 people across its global operations.

Job Description Summary:

The Senior Scientist (Microbiologist) is responsible to work with a diverse group of scientists engaged in basic and applied research to provide innovative products and solutions for reducing hospital acquired infections and improving the quality of health care. 

Job Description 
 

• Responsible for Microbiology and Life-sciences related disciplines performing basic and applied research to provide innovative solutions for reducing hospital acquired infections and improving the quality of health care
• Demonstrates developed knowledge of microbial physiology and pathogenicity, mode-of-action of antimicrobials, resistance and cross-resistance to antimicrobials, bacterial biofilms, in-vitro, ex-vivo and in-vivo models for the evaluation of antimicrobial drug products and medical devices, and related standard scientific methods and techniques
• Conceives, plans, and executes projects related to the strategic needs of the infection prevention business unit
• Utilizes current scientific/regulatory knowledge related to preclinical microbiological and biochemical testing of products under development
• Generates and analyses data to provide meaningful insights and makes data-driven recommendations to project and management teams. Identifies and communicates the implication of relevant scientific observations
• Works with cross-functional teams and prepares Microbiology documents for regulatory filings (IND, NDA, PAS, 510K, etc.)
• Performs antimicrobial susceptibility testing of bacteria and fungi by following various Clinical and Laboratory Standards Institute (CLSI), USP/BP/JP/EN/NF, ASTM based standards and guidelines
• Is familiar with the FDA Tentative Final Monograph (TFM) for safety and effectiveness of health care antiseptics and topical antimicrobial drug products for human use
• Communicates and justifies experimental designs, answers scientific questions, and proactively identifies and proposes solutions to technical problems
• Mentors scientific team members and plays active role in creation of new SOPs, revision of SOPs and troubleshooting for microbiological investigations
• Applies knowledge of advanced microbiological techniques and good laboratory practices on daily basis
• Perform all other related duties as assigned

Qualifications:
 

• Ph.D. in Microbiology or Biological/Biomedical Sciences with relevant laboratory experience in medical device or pharmaceutical R&D environment
• Demonstrated success in design and development of Microbiology protocols to support product registrations
• Prior experience with antimicrobial agents, antiseptics, and disinfectants; and associated testing methods
• Experience in the selection and validation of a growth or non-growth based rapid microbiological method (RMM) as an alternate to compendial method is desirable
• Conversant with GLP/GCP/cGMP and global Drug and Device Development Processes