Harba Solutions Inc.
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Base pay range
$120,000.00/yr - $150,000.00/yr Direct message the job poster from Harba Solutions Inc. Build, lead, and support a diverse team of microbiologists responsible for executing a full range of microbiological testing in a GMP environment. Deliver effective training, development, and oversight to ensure laboratory personnel maintain strong technical skills and operate in full compliance with internal procedures and regulatory expectations. Provide scientific leadership at the bench level to maintain high quality and technical standards within the QC lab. Design and implement a robust environmental monitoring (EM) program, along with laboratory workflows to support testing for sterility, endotoxin, bioburden, and other microbiological assays relevant to pharmaceutical products, raw materials, and manufacturing processes. Serve as a cross-functional liaison to coordinate laboratory activities—including sampling, testing, instrumentation, and staffing—aligned with operational timelines and client expectations. Promote a safety-first culture by clearly communicating safety expectations, reinforcing safe behaviors, and intervening proactively when needed. Maintain continuous inspection-readiness for internal audits and regulatory inspections. Serve as a primary contact for auditors, demonstrating compliance with cGMPs, cGLPs, and global regulatory guidelines. Lead laboratory investigations, utilizing root cause analysis tools to identify issues and implement timely corrective actions for deviations such as OOS or OOT results. Manage the full lifecycle of laboratory documentation and records using electronic and paper-based systems (e.g., QMS, LIMS), including authorship, review, approval, and archival. Apply statistical analysis and trend evaluation techniques to microbiology data to drive process improvements and reduce variability. Monitor evolving regulatory guidance and industry trends. Leverage continuing education, professional networks, and relevant publications to ensure laboratory practices remain aligned with industry best practices. Oversee the qualification, calibration, and maintenance of laboratory instruments and controlled environments. Collaborate with validation and metrology teams to support IQ/OQ/PQ protocols. Qualifications: Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific field. At least 5 years of experience in the biopharmaceutical industry, including a minimum of 2 years focused on microbiological testing in a GMP aseptic manufacturing setting. Strong working knowledge of global regulatory requirements (FDA, EMA, etc.) relevant to microbiological quality control, including participation in audits or inspections. Experience in USP/EP microbiology testing and suitability studies. Proficient in laboratory equipment validation and qualification procedures. Demonstrated ability to manage electronic lab systems such as LIMS and data analysis tools (e.g., JMP, Minitab). Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Manufacturing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Harba Solutions Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Microbiology Manager jobs in
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$120,000.00/yr - $150,000.00/yr Direct message the job poster from Harba Solutions Inc. Build, lead, and support a diverse team of microbiologists responsible for executing a full range of microbiological testing in a GMP environment. Deliver effective training, development, and oversight to ensure laboratory personnel maintain strong technical skills and operate in full compliance with internal procedures and regulatory expectations. Provide scientific leadership at the bench level to maintain high quality and technical standards within the QC lab. Design and implement a robust environmental monitoring (EM) program, along with laboratory workflows to support testing for sterility, endotoxin, bioburden, and other microbiological assays relevant to pharmaceutical products, raw materials, and manufacturing processes. Serve as a cross-functional liaison to coordinate laboratory activities—including sampling, testing, instrumentation, and staffing—aligned with operational timelines and client expectations. Promote a safety-first culture by clearly communicating safety expectations, reinforcing safe behaviors, and intervening proactively when needed. Maintain continuous inspection-readiness for internal audits and regulatory inspections. Serve as a primary contact for auditors, demonstrating compliance with cGMPs, cGLPs, and global regulatory guidelines. Lead laboratory investigations, utilizing root cause analysis tools to identify issues and implement timely corrective actions for deviations such as OOS or OOT results. Manage the full lifecycle of laboratory documentation and records using electronic and paper-based systems (e.g., QMS, LIMS), including authorship, review, approval, and archival. Apply statistical analysis and trend evaluation techniques to microbiology data to drive process improvements and reduce variability. Monitor evolving regulatory guidance and industry trends. Leverage continuing education, professional networks, and relevant publications to ensure laboratory practices remain aligned with industry best practices. Oversee the qualification, calibration, and maintenance of laboratory instruments and controlled environments. Collaborate with validation and metrology teams to support IQ/OQ/PQ protocols. Qualifications: Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific field. At least 5 years of experience in the biopharmaceutical industry, including a minimum of 2 years focused on microbiological testing in a GMP aseptic manufacturing setting. Strong working knowledge of global regulatory requirements (FDA, EMA, etc.) relevant to microbiological quality control, including participation in audits or inspections. Experience in USP/EP microbiology testing and suitability studies. Proficient in laboratory equipment validation and qualification procedures. Demonstrated ability to manage electronic lab systems such as LIMS and data analysis tools (e.g., JMP, Minitab). Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Manufacturing Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Harba Solutions Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Microbiology Manager jobs in
Indianapolis, IN . Supervisor, Medical Technologist - Microbiology
Sr. Manager, Quality Assurance for Quality Control
Senior Food Safety Quality Assurance Manager
Indiana, United States $75,000.00-$90,000.00 2 weeks ago Indiana, United States $110,000.00-$120,000.00 4 days ago Indianapolis, IN $117,400.00-$136,967.00 2 weeks ago Senior Quality Assurance Operations Manager
Assurance Manager, Quality Management - IS Assurance
Indianapolis, IN $100,000.00-$150,000.00 1 week ago Indianapolis, IN $125,000.00-$140,000.00 2 days ago Indianapolis, IN $106,000.00-$146,000.00 1 week ago Indianapolis, IN $106,000.00-$146,000.00 1 week ago Scientist I, Microbiology - Indianapolis, IN
Indianapolis, IN $75,000.00-$116,500.00 3 weeks ago Supervisor, Medical Technologist - Microbiology
Manager, Quality Assurance Engineer AI/ML
Greater Indianapolis $124,600.00-$255,900.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr