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Senior Microbiologist: Endotoxin & Sterility Lead

$60k - $75k

Raise - find a more meaningful working experience

Microbiologist III Pay Rate: $60K - $75K USD Yearly Location: Oklahoma City, OK (On-site) Job Description This is an advanced-level position for a highly motivated and experienced Microbiologist with a pharmaceutical/biotech background, with strong experience in sterile environments and endotoxin testing. The role offers a wide range of responsibilities, progressively increasing in complexity; independently troubleshoot and resolve testing and organizational issues and analyze and interpret data to ensure accuracy and adherence to USP and regulatory guidelines. May also be trained to assist in Data Review as needed. Working independently with limited supervision, performing complex microbiological testing of compounded sterile and non-sterile pharmaceuticals. Performs Endotoxin tests on non-sterile pharmaceuticals, taking on advanced isolation of specific microorganisms and evaluating causes of contamination sources, and reviewing test data of junior department members for accuracy. Furthermore, the Microbiologist III will take on mentoring junior staff, manage client communication, and participate in cross-departmental discussions, providing valuable expertise in developing processes and procedures for wide and complex technical and operations issues. May at times lead strategic projects. Essential Functions Completion of various microbiology tests including compounded sterile and non-sterile pharmaceuticals. Perform Bacterial Endotoxin Tests for Category 2 and 3 compounded sterile preparations and use endotoxin challenge vials to determine if drug products are non-pyrogenic. Review Closed and Open Membrane Filtration test data to check for quality control of Sterility testing for clients. Use different Growth Media specific to the goal of the test being performed to identify and screen for specific organisms that would be particularly dangerous for each product and/or dosage form. Use techniques such as gram stain reaction, morphology, and metabolic reaction to isolate microorganisms for accurate identification and testing, and to determine causes of contamination in client samples. Perform Container Closure Integrity Testing (CCIT) on IV bags, syringes, cassettes, and vials to determine the entry of microorganisms. Participate in discussions with cross-department personnel and external agencies to assess advanced technical and operational issues from sample and project testing to results and SOP statements. Answer client FAQs and advanced non-routine complex calls that involve detailed analysis of testing and results, via email or phone, promptly and professionally. Mentor and assist in coaching and development of junior-level laboratory personnel in performing tests and understanding protocols. Strict adherence to Standard Laboratory Operations, Quality Management Systems (QMS), and Current Good Manufacturing Practice (cGMP) guidelines. Adhere to, use, and maintain Personal Protective Equipment (PPE) and Laboratory Safety Equipment and identify hazards that may arise. Oversee chemicals with classifications of Hazardous, Toxic, Corrosive, Flammable, or Oxidizing. Ability to wear a full-face respirator in addition to standard Personal Protective Equipment. Complete all safety training including but not limited to OSHA, departmental SOPs, and company compliance. May also be trained to assist in Data Review as needed. Adherence to all company safety standards, policies, procedures, and protocols. Maintain adequate attendance as per department and company expectations. Perform all other duties as assigned. Key Skills, Abilities & Success Factors Knowledge of Microbiology and Testing Methodology. Technical Capacity: Ability to use various sensitive laboratory equipment. Analytical/Problem-Solving Skills: Ability to analyze and interpret data from tests including sterility, fungal, and endotoxins. Detail Proficiency: Strong attention to detail and accuracy. Organization Skills: Ability to manage multiple samples with strict controls. Collaboration Proficiency: Ability to work independently and within a team environment. Professional Verbal and Written Communication. Time Management: Ability to meet time-sensitive deadlines. Digital Literacy: Proficiency in MS Office and LIMS. Intercultural Sensitivity. Minimum Qualifications Education: Bachelor’s degree in Microbiology or equivalent Diploma Work Experience: 2 years of experience in a microbiology laboratory setting 2 years of experience in performing detailed microbiology tests Preferred Qualifications Education: Master’s degree in Microbiology or equivalent Diploma Work Experience: 3 years of experience in a microbiology laboratory setting Experience with microbiology testing methodology Experience with Laboratory Information Management Systems (LIMS) Experience in the Pharmaceutical Industry Looking for meaningful work? We can help Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we’re a certified B Corporation and donate 10% of our profits to charity. We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities. We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation: In order to submit candidates for roles, our clients will sometimes require personal information to confirm the identity of applicants and their legal status to work. Raise will never ask you for personal or banking information unless you have been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at View phone number on click.appcast.io or View email address on click.appcast.io #IMW

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Vacancy posted 2 days ago
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