RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Microbiology Manager to work with our growing Microbiology Team  as we scale towards commercial manufacturing in the next upcoming months.? As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team.
 

This position is located in East Windsor, NJ and is required to be onsite. 

If this sounds interesting to you, it’s probably because up to this point you have:

• 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. 

The main expectations and responsibilities for this position are:

• 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. 

If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation.

We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.