Sr. Manager, QC Microbiology
Position: Senior Manager, QC Microbiology
Location: Fargo, North Dakota (Can Provide Relocation)
A rapidly growing biologics company in Fargo, ND that's looking for a Senior Manager of QC Microbiology to lead their microbiology operations in a state-of-the-art GMP facility. This is a high-impact leadership role where you'll oversee a talented team, drive compliance and innovation, and serve as a key SME during regulatory inspections. If you're passionate about microbiological quality control and want to make a difference in a company with a strong pipeline and collaborative culture, this could be the perfect fit.
Responsibilities:
- Leading and mentoring the QC Microbiology team, fostering a culture of excellence and accountability.
- Overseeing environmental and utility monitoring programs, sterility testing, endotoxin, bioburden, and microbial ID.
- Acting as the go-to SME for microbiology during audits and regulatory inspections (FDA, EMA, etc.).
- Collaborating cross-functionally with QA, Manufacturing, and Regulatory to support product release and investigations.
- Driving continuous improvement initiatives in lab operations, data integrity, and contamination control.
Qualifications:
- 8+ years of QC Microbiology experience in biologics or pharmaceuticals, with 3+ years in leadership.
- Strong knowledge of aseptic processing, GMP regulations, and microbiological testing methods.
- Experience managing EM programs and leading teams in a regulated environment.
- Excellent communication and leadership skills.
- Bachelor's degree in Microbiology or related field (Master's or PhD preferred).
If this sounds interesting, please do not hesitate to apply in directly for further information!
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