Sr. Scientist / Principal Scientist, Microbiology
Sr. Scientist / Principal Scientist, Microbiology
Posted on :
19-07-2025
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1 Vacancy
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Job Description
MannKind Corporationfocuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes nontuberculous mycobacterial (NTM) lung disease pulmonary fibrosis and pulmonary signature technologies dry-powder formulations and inhalation devices offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation depending on the target indication.
Position Summary:
This position will play a key role in the review and analysis of clinical microbiology and PK data from the MannKind ICON-1 phase 3 trial that evaluates the efficacy and safety of Clofazimine Inhalation Suspension on top of guideline-based therapy (GBT). Reporting to the Director of Microbiology this subject matter expert (SME) will work closely with our partner Clinical Research Organizations (CROs) and central microbiology laboratories to review and finalize individual patient reports in a timely manner prior to release and to closely monitor the unblinded microbiology data reported during the conduct of the trial. This individual will work in close collaboration with the Directors of Microbiology and Clinical Data Operations and the Clinical Trial Physician to monitor the processing of sputum specimens for microbiology assessment and PK analyses in accordance with the clinical trial protocol. Previous clinical trial experience is an advantage but not essential. This position can located at our Bedford MA Westlake Village CA or Danbury CT site.
This position will play a key role in the review and analysis of clinical microbiology and PK data from the MannKind ICON-1 phase 3 trial that evaluates the efficacy and safety of Clofazimine Inhalation Suspension on top of guideline-based therapy (GBT). Reporting to the Director of Microbiology this subject matter expert (SME) will work closely with our partner Clinical Research Organizations (CROs) and central microbiology laboratories to review and finalize individual patient reports in a timely manner prior to release and to closely monitor the unblinded microbiology data reported during the conduct of the trial. This individual will work in close collaboration with the Directors of Microbiology and Clinical Data Operations and the Clinical Trial Physician to monitor the processing of sputum specimens for microbiology assessment and PK analyses in accordance with the clinical trial protocol. Previous clinical trial experience is an advantage but not essential. This position can located at our Bedford MA Westlake Village CA or Danbury CT site.
Responsibilities include but are not limited to:
- To work independently in an efficient and organized manner to review unblinded data generated by our partner Microbiology Laboratories for accuracy quality assurance and adherence to study-specific procedures and data management plans prior to reporting. The work requires a professional level of knowledge to read and interpret accurately test results used in the diagnosis and treatment of nontuberculous mycobacterial (NTM) lung disease.
- To monitor data quality and report identified issues for correction to the central laboratories in a timely manner for final reporting and timely data dissemination to clinical trial sites (as appropriate) and clinical database consistent with the study protocol.
- To effectively track the microbiology results reported during the trial conduct and communicate results (as appropriate) to the clinical team at key milestones.
- To support the Directors of Microbiology and Clinical Data Operations with various results analyses review and summary of scientific literature and scientific report writing.
- To support the Director of Microbiology as required review and analyze data reported from contracted in vitro studies.
Education and Experience:
- Minimum requirements: A Bachelors degree in Biological Science (BS) Clinical Laboratory Science (CLS) or Medical Technology (MT) with American Society for Clinical Pathology (ASCP) certification with a minimum of 6-8 years clinical laboratory experience at a senior level.
- Ability to work independently in an efficient and organized manner to review unblinded data and preliminary reports generated by Microbiology Laboratories to assure accuracy prior to final reporting.
- The work requires subject matter expertise to read and interpret the accuracy of test results used in the diagnosis and treatment of nontuberculous mycobacterial (NTM) lung disease.A familiarity with CLSI documents relevant to the laboratory detection and identification of Mycobacteria and performance standards for the susceptibility testing of Mycobacteria is preferred.
- Strong verbal and written communication skills experience in reviewing scientific papers and scientific report writing.
- Ability to work independently and within a team environment
Required Experience:
Staff IC
Employment Type
Full Time
Key Skills
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