RK Pharma Inc
Microbiology Manager – RK Pharma Inc
RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking a Microbiology Manager to lead our growing Microbiology Team as we scale towards commercial manufacturing in the coming months. Our focus is on the development, manufacturing, and sale of high‑quality and affordable generic pharmaceutical products worldwide.
Location: East Windsor, NJ (required to work onsite).
Responsibilities
Oversee all microbiological testing and environmental monitoring programs for manufacturing and warehouse areas.
Supervise and develop microbiology staff, ensuring training, competency, and adherence to SOPs and GMP standards.
Review and approve microbiological test data, reports, and investigations, ensuring accuracy and compliance.
Manage cleanroom qualification, aseptic media fill, and utility (WFI, compressed air) monitoring programs.
Lead investigations into contamination events, environmental excursions, and OOS results, driving root cause analysis and CAPAs.
Ensure laboratory instruments and equipment are calibrated, maintained, and qualified per regulatory expectations.
Support regulatory inspections and internal audits, providing documentation and expert technical responses.
Collaborate cross‑functionally with QA, Production, and Facilities to sustain a robust contamination control strategy.
Drive continuous improvement initiatives to enhance laboratory efficiency, data integrity, and compliance.
Requirements
Bachelor’s or Master’s degree in Microbiology, Biology, or a related life science discipline.
7+ years of experience in pharmaceutical microbiology or aseptic manufacturing environments, with at least 3 years in a supervisory or management role.
Strong working knowledge of cGMP, GLP, USP, and FDA regulations.
Expertise in environmental monitoring (EM), water system testing, microbial limits, endotoxin, and sterility testing.
Experience overseeing cleanroom qualification, aseptic process validation, and contamination control programs.
Proficiency with LIMS, EM software, and data integrity practices.
Demonstrated ability to lead teams, manage laboratory schedules, and coordinate with QA and manufacturing.
Excellent analytical, documentation, and problem‑solving skills.
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industries: Pharmaceutical Manufacturing
If this sounds like a good fit for you, please apply to start a conversation. We look forward to learning more about you and the skills you can bring to RK Pharma Inc.
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Location: East Windsor, NJ (required to work onsite).
Responsibilities
Oversee all microbiological testing and environmental monitoring programs for manufacturing and warehouse areas.
Supervise and develop microbiology staff, ensuring training, competency, and adherence to SOPs and GMP standards.
Review and approve microbiological test data, reports, and investigations, ensuring accuracy and compliance.
Manage cleanroom qualification, aseptic media fill, and utility (WFI, compressed air) monitoring programs.
Lead investigations into contamination events, environmental excursions, and OOS results, driving root cause analysis and CAPAs.
Ensure laboratory instruments and equipment are calibrated, maintained, and qualified per regulatory expectations.
Support regulatory inspections and internal audits, providing documentation and expert technical responses.
Collaborate cross‑functionally with QA, Production, and Facilities to sustain a robust contamination control strategy.
Drive continuous improvement initiatives to enhance laboratory efficiency, data integrity, and compliance.
Requirements
Bachelor’s or Master’s degree in Microbiology, Biology, or a related life science discipline.
7+ years of experience in pharmaceutical microbiology or aseptic manufacturing environments, with at least 3 years in a supervisory or management role.
Strong working knowledge of cGMP, GLP, USP, and FDA regulations.
Expertise in environmental monitoring (EM), water system testing, microbial limits, endotoxin, and sterility testing.
Experience overseeing cleanroom qualification, aseptic process validation, and contamination control programs.
Proficiency with LIMS, EM software, and data integrity practices.
Demonstrated ability to lead teams, manage laboratory schedules, and coordinate with QA and manufacturing.
Excellent analytical, documentation, and problem‑solving skills.
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industries: Pharmaceutical Manufacturing
If this sounds like a good fit for you, please apply to start a conversation. We look forward to learning more about you and the skills you can bring to RK Pharma Inc.
#J-18808-Ljbffr