About Next X Labs
Next X Labs LLC is seeking an experienced GMP QC Microbiologist to assist with the build-out of a scalable analytical testing lab supporting pharmaceutical product release, API batch release, and 503A stability studies.
Position Summary:
The Senior QC Microbiologist will serve as the technical leader for the Analytical Microbiology Laboratory at Next X Labs and play a critical role in establishing a world-class GMP QC laboratory from the ground up. During the laboratory startup phase, this individual will lead the selection, and IQ/OQ/PQ of analytical instrumentation, process verification, develop standard operating procedures (SOPs), training programs, support Quality Assurance initiatives, and serve as the microbiological technical expert during client and audit interactions as appropriate.
The position will be heavily focused on technical writing and equipment/ process qualification during the initial build-out, clean room and separative device environmental monitoring.
This individual will also be responsible for establishing programs for the procurement, qualification, handling, storage, inventory management, traceability, and routine use of microbiological reference standard organisms and challenge organisms in accordance with USP requirements and recognized industry best practices.
As laboratory operations mature and validated methods are released for routine use, the role will transition into technical and operational leadership of the microbiology laboratory. Responsibilities will expand to include:
-Supervision and professional development of QC analysts
-Oversight of sample scheduling and prioritization
-Lab workflow and throughput optimization
-Inventory management, including reference standard organisms and media growth promotion
-Coordinating closely with QC Chemistry
-Supporting QA investigations
-Contribute to drafting and executing stability studies
-Expansion of test catalog and throughput to support business growth
Key Test Methods:
-USP <85>
-Endotoxin Systems
-USP <73>, <74>, <1223> Sterility: Rapid testing (Celsis/ Milliflex)
-USP <60>, <61>, <62> Bioburden: Traditional 3-5 day
-USP <1223> Bioburden: Rapid testing (Milliflex)
-USP <51> Antimicrobial Efficacy/ Preservative Effectiveness
-Environmental monitoring (non-viable air, viable air, viable surface, temp/RH, differential pressure)
-Subvisible particulate analysis (HIAC 9703+)
-Willingness and ability to learn other analytical test methods to meet internal needs or support client requests
Applicable Regulatory Knowledge:
-21 CFR Parts 210/211; 21
-CFR Part 11; FDA Data Integrity guidance; ISO 14644; familiarity with ISO/IEC 17025 is a plus.
Qualifications:
-Bachelor's degree in Microbiology or related science (Master's preferred).
-7+ years of GMP pharmaceutical microbiology experience.
-Strong technical writing and validation experience.
-Experience supporting regulatory inspections and client audits.
-Excellent communication and project management skills.
Compensation & Growth:
Competitive salary commensurate with experience, performance bonus eligibility, comprehensive benefits, continuing education support, and a defined growth path to Microbiology Laboratory Manager or Director of QC Microbiology as Next X Labs expands.
Pay: $80,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
Work Location: In person
