Development Laboratory Manager Jobs in Cedar Rapids, IA

Element has a current opening for a Microbiologist II at our North Liberty, IA location. Under general direction, the Microbiologist II performs moderate to highly complex laboratory testing and analysis on bacterial and fungal isolates to provide information to the SENTRY program, new drug development protocols and clinical trial protocols. Utilizes professional skill and judgement to perform a variety of microbiology procedures within the laboratory.

• Processes incoming bacterial and fungal isolates following safety guidelines and using requiredPPE, selects and labels appropriate media and properly streaks for isolation.
• Assesses isolates that are received using professional judgment, knowledge of organismcharacteristics, MALDI-TOF and biochemical tests to properly identify organisms prior to banking.
• Performs MALDI-TOF isolate identifications and interprets results.
• Properly pulls frozen isolates from the bank for SENTRY, drug development protocol testing andclinical trials.
• Prepares for susceptibility runs by performing purity checks, removing MIC panels from freezers,labeling of panels and tubes, and loosening caps on media tubes.
• Participates in all aspects of MIC testing including subbing isolates, preparing inoculums,pipetting, and running inoculating instruments.
• Interprets MICs results from broth microdilution, agar dilution, disk diffusion and Etestmethodologies.
• Participates on the clinical trial team or alternatively, is a member of the fungal team and isdeemed proficient in one or more areas (fungal processing, yeast or mould susceptibility testing,etc.) as dictated by business need. May perform highly complex quantitative and qualitative analysis on microbiological isolates forclinical trial and research protocols.
• Participates in new drug development protocols and clinical trial protocols, if part of clinical trialteam, which includes an array of susceptibility testing techniques (Broth microdilution + disksand/or Etest, agar dilution, time-kills, PAEs, etc.).
• If part of the clinical trial team, follows GCP and CLIA regulations for processing of clinical trialisolates, which includes chain of custody procedures. Participates in the overall quality assurance program by performing QC testing and documentingresults appropriately.
• Informs Laboratory Manager and QA department if failures are observed and carries outrecommended corrective actions.
• Provides direction to Laboratory Assistants with regard to processing specimens, susceptibilitytesting and pulling isolates from the bank.
• Provides technical direction and oversight to Microbiologist I on complex testing and analysis ofmicrobiological isolates.
• Participates in training of Laboratory Assistants and Microbiologist I on testing techniques andinterpretation of results, as required.
• Calibrates, troubleshoots, and conducts routine maintenance on laboratory instrumentation.
• Investigates and resolves problems related to testing procedures.
• Complies with applicable regulatory and safety requirements of the laboratory.
• Effectively communicates issues and ideas for efficiencies to the Laboratory Manager and Lab Coordinator.
• Assists with writing and revising laboratory procedures according to CLSI and regulatoryguidelines.
• Performs routine cleaning and maintenance tasks within the laboratory
• Demonstrates professional development.

• Bachelor's Degree in a laboratory science field from an accredited college or university or an equivalent combination of EDUCATION AND EXPERIENCE is required.
• Certification by the American Society of Clinical Pathologists or National Certifying Agency is desirable.
• Must meet the CLIA Testing Personnel Qualifications for High Complexity Testing 493.1489 to perform clinicaltrial work.
• Previous experience working in a microbiology laboratory, including familiarity with organism morphology, handling of bacterial cultures and experience with aseptic technique is required.
• Previous experience conducting antimicrobial susceptibility testing of bacteria and fungi (yeasts and molds) using broth microdilution, agar dilution, and disk/test strips, clinical laboratory work in a microbiology laboratory, and experience with a MALDI-TOF for organism identification are preferred.

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Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) 

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