Scientist Consultant (QC/AS) IV

Summary

Our mid-sized, growing pharmaceutical client is seeking a Microbiologist consultant who will ensure appropriate execution, representation, and protection of the client's microbiology needs within current clinical trials and in collaborations with various companies / academic institutions across multiple TB alliances.

General Duties / Expectations of Role :

• Provide input to protocols, dossiers, and lab / site materials with microbiology expertise and analytical proficiency
• Ensure vendors are properly managed and supported to perform cultures and other related TB specific testing; including

o of issues (eg contaminated media, unexpected laboratory results) and development of mitigation measures (eg drug washing protocol method for drug carryover issue)

oMaintaining alignment with client needs when interacting with other TB alliance contributors

• Oversee various testing methods, and validation efforts (eg, EUCAST adoption) including processes / methods / efforts being developed internally and externally
• Liaise with collaborators to represent, outline, and ensure cross-functional involvement to drive microbiology-specific goals
• Coordinate for delivery of microbiology-specific items to alliances (eg, data sharing)
• Perform data review
• Provide training for cross-functional team members as needed to broaden microbiology strengths
• Prepare and maintain QC documentation, including protocols, reports, and test methods
• Assist in audits of external analytical laboratories
• Procure and monitor reference materials at contract analytical laboratories
• Create the timelines of the analytical activities to meet the broader project timeline

Qualifications :

• Bachelor’s degree required, preferably in microbiology, medical technology, or a related field. Advanced degree in a relevant discipline preferred.
• Minimum of 5 years experience in clinical microbiology, including bacterial identification, drug susceptibility testing, and knowledge of molecular techniques;

specialty experience in mycobacteriology highly preferred.

• Excellent understanding and knowledge of microbiology aspects related to tuberculosis identification and treatment.
• Laboratory experience with automated microbiology identification and susceptibility test systems, preferably hands-on Bactec MGIT experience.
• Strong knowledge of quality control and quality assurance systems.
• Knowledge of clinical trial research; ideally, 1-2 years experience working in clinical trials for a pharmaceutical company.
• Working comprehension of CLSI, EUCAST, WHO, and FDA guidelines and regulations.
• Proficient with commercial computer software applications (spreadsheets, databases, word processing, etc.).
• International work experience in resource-limited countries desired.

Term & Start

• 12+ month contract option to extend.
• Start 2-3 weeks from the offer.
• 2 Video Screen
• Hybrid Ability to travel to Rockville, MD
• Benefits included (Medical, Dental, Vision, 401k)
30+ days ago