Xseerpharma
Xseer Pharmaceuticalsis seeking an experienced and motivated QC Microbiologist to lead our Environmental Monitoring (EM) Program and perform critical microbiological quality control activities. The QC Microbiologist will be responsible for overseeing EM operations, conducting and reviewing microbiological testing, supporting method development, and ensuring regulatory compliance in accordance with cGMP and FDA requirements.
This role serves as a subject matter expert (SME) in microbiology and environmental control, ensuring product sterility, data integrity, and microbial control across all cleanroom operations.
Key Responsibilities:
Supervise and coordinate the daily EM program including viable/non-viable air sampling, surface monitoring, personnel monitoring, and utility sampling.
Provide technical guidance to EM Specialists; ensure sampling is conducted per SOPs, aseptic technique, and regulatory standards (ISO 5, 7, and 8).
Review EM results, analyze trends, and author periodic reports (monthly/quarterly/annual).
Escalate abnormal trends or OOS results and lead risk assessments.
Approve and oversee cleanroom certification support and room release.
Microbiological QC Testing
Perform and/or supervise sterility testing (per USP
), bacterial endotoxin testing (BET, per USP
), bioburden testing, and particulate matter testing (per USP
). Perform growth promotion, microbial limits, and water testing (TOC, conductivity, microbial). Maintain control organisms and ensure media qualification. Validate and maintain microbiological test methods in alignment with compendial requirements and internal validation protocols. Investigations and CAPA Participate in and/or lead microbiological investigations related to environmental monitoring, sterility failures, gowning excursions, and manufacturing deviations. Support root cause analysis and CAPA development. Write and review investigation reports and justifications for batch disposition. Documentation and Compliance Review EM and QC microbiology data for accuracy and completeness. Ensure compliance with cGMP, FDA 503B guidance, USP
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. Uphold data integrity standards per ALCOA+ principles. Participate in internal audits, regulatory inspections, and customer audits. Training and Mentorship Train and qualify personnel on aseptic techniques, gowning, EM procedures, and microbiological testing. Develop and maintain training records and competency assessments for EM staff. Project and R&D Support Assist with microbiological method development and validation for new products and formulations under contract development. Provide microbiology input into formulation studies, stability protocols, and manufacturing processes for clinical and commercial drug products. Qualifications: Bachelor’s degree in Microbiology, Biology, or related field (Master’s preferred). Minimum 3 years of microbiology experience in sterile pharmaceutical manufacturing, with at least 1 year supervising or leading EM programs. Strong understanding of aseptic processing and cleanroom behavior. Expertise in cGMP regulations, FDA 503B guidance, USP, and ISO cleanroom standards. Experience with BET, sterility testing, growth promotion, and environmental monitoring trending. Competency using EM systems (e.g., Lighthouse, PMS, or BioTrak) and software (eQMS, LIMS). Excellent communication, documentation, and data analysis skills. Preferred Skills: Prior experience at a 503B outsourcing facility or CDMO. Experience with method development or rapid microbiological methods (RMM). Familiarity with environmental excursions, gowning failures, and aseptic media fill evaluations. Health, Dental, and Vision Insurance Paid Time Off (PTO) 401(k) with employer match Career development and professional growth opportunities Schedule: 8-hour shift Monday to Friday (occasional weekend or off-shift work may be required during EM or media fill operations)
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), bacterial endotoxin testing (BET, per USP
), bioburden testing, and particulate matter testing (per USP
). Perform growth promotion, microbial limits, and water testing (TOC, conductivity, microbial). Maintain control organisms and ensure media qualification. Validate and maintain microbiological test methods in alignment with compendial requirements and internal validation protocols. Investigations and CAPA Participate in and/or lead microbiological investigations related to environmental monitoring, sterility failures, gowning excursions, and manufacturing deviations. Support root cause analysis and CAPA development. Write and review investigation reports and justifications for batch disposition. Documentation and Compliance Review EM and QC microbiology data for accuracy and completeness. Ensure compliance with cGMP, FDA 503B guidance, USP
,
,
,
,
,
, and
. Uphold data integrity standards per ALCOA+ principles. Participate in internal audits, regulatory inspections, and customer audits. Training and Mentorship Train and qualify personnel on aseptic techniques, gowning, EM procedures, and microbiological testing. Develop and maintain training records and competency assessments for EM staff. Project and R&D Support Assist with microbiological method development and validation for new products and formulations under contract development. Provide microbiology input into formulation studies, stability protocols, and manufacturing processes for clinical and commercial drug products. Qualifications: Bachelor’s degree in Microbiology, Biology, or related field (Master’s preferred). Minimum 3 years of microbiology experience in sterile pharmaceutical manufacturing, with at least 1 year supervising or leading EM programs. Strong understanding of aseptic processing and cleanroom behavior. Expertise in cGMP regulations, FDA 503B guidance, USP, and ISO cleanroom standards. Experience with BET, sterility testing, growth promotion, and environmental monitoring trending. Competency using EM systems (e.g., Lighthouse, PMS, or BioTrak) and software (eQMS, LIMS). Excellent communication, documentation, and data analysis skills. Preferred Skills: Prior experience at a 503B outsourcing facility or CDMO. Experience with method development or rapid microbiological methods (RMM). Familiarity with environmental excursions, gowning failures, and aseptic media fill evaluations. Health, Dental, and Vision Insurance Paid Time Off (PTO) 401(k) with employer match Career development and professional growth opportunities Schedule: 8-hour shift Monday to Friday (occasional weekend or off-shift work may be required during EM or media fill operations)
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