Planet Pharma
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Target PR Range: 80-89/hr
*Depending on experience
The role is Microbiologist- See description below and note there is no lab or bench work:
Microbiology Resource Request
Resource needed with microbiology background to ensure appropriate execution, representation and protection of microbiology needs within current clinical trials and in collaborations with various companies / academic institutions across multiple TB alliances
General description - this resource would be responsible to do the following:
• Provide input to protocols, dossiers, 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 Identification / management of issues (eg contaminated media, unexpected laboratory results) and development of mitigation measures (eg drug washing protocol method for drug carryover issue)
o Maintaining alignment with needs when interacting with other TB alliance contributors
• Oversee various testing methods, validation efforts (eg, EUCAST adoption) including process/methods/efforts being developed internally, and externally from partners
• 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
Proposed 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 the 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.
*CO/NYC candidates might not be considered
Microbiologist
Posted: 05/25/2023
2023-05-25
2023-06-30
Employment Type:
Contract
Job Category: Scientific
Job Number: 562086-1
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 80-89/hr
*Depending on experience
The role is Microbiologist- See description below and note there is no lab or bench work:
Microbiology Resource Request
Resource needed with microbiology background to ensure appropriate execution, representation and protection of microbiology needs within current clinical trials and in collaborations with various companies / academic institutions across multiple TB alliances
General description - this resource would be responsible to do the following:
• Provide input to protocols, dossiers, 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 Identification / management of issues (eg contaminated media, unexpected laboratory results) and development of mitigation measures (eg drug washing protocol method for drug carryover issue)
o Maintaining alignment with needs when interacting with other TB alliance contributors
• Oversee various testing methods, validation efforts (eg, EUCAST adoption) including process/methods/efforts being developed internally, and externally from partners
• 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
Proposed 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 the 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.
*CO/NYC candidates might not be considered
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