Quality Control Microbiologist

Job Description

Job Description

???? We’re Growing at Eckert & Ziegler Radiopharma, Inc. – Join Us in Wilmington, MA!

Eckert & Ziegler Radiopharma, Inc. is entering an exciting phase of growth as we build and scale operations to support the future of radiopharmaceuticals. Based in Wilmington, MA, we're hiring across several key functions and looking for mission-driven individuals who thrive in a fast-paced, collaborative environment.

If you're passionate about making a real impact in healthcare — or know someone who might be — we’d love to connect. We’re building something special here at Eckert & Ziegler Radiopharma, Inc., and there’s plenty of opportunity for talented, motivated professionals to grow with us.

Position Summary

We are seeking a Senior QC Microbiologist to lead microbiological testing, environmental monitoring, and contamination control programs in our GMP manufacturing facility. This hands-on role is critical to ensuring product quality and compliance with regulatory requirements for sterile radiopharmaceutical products.

Key Responsibilities

• Perform microbiological testing including bioburden, endotoxin, sterility, and microbial identification.
• Lead and support environmental monitoring (EM) of classified cleanroom spaces.
• Assist in the development and execution of site-wide strategies for environmental control, contamination prevention, and sterility assurance.
• Review and trend EM data and investigate excursions or out-of-specifications (OOS).
• Author and revise SOPs, protocols, and technical reports related to microbiology.
• Train and mentor staff on aseptic technique, gowning, and cleanroom behavior.
• Support aseptic process simulations (media fills) and cleanroom qualifications.
• Participate in internal audits, regulatory inspections, and quality investigations.
• Stay current with FDA, EMA, USP, and ICH microbiology guidance and best practices.
• Contribute to continuous improvement and regulatory readiness initiatives.

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, or related life science field.
• 6–8+ years of microbiology experience in a cGMP pharmaceutical, biologics, or sterile manufacturing environment.
• Strong understanding of aseptic technique, contamination control, and microbiological testing methods.
• Familiarity with cleanroom classifications and environmental monitoring programs.
• Excellent documentation and communication skills.
• Experience supporting audits and regulatory inspections is a plus.

Work Schedule & Conditions

• Standard day shift; flexibility for occasional off-hours support.
• Must be able to stand for extended periods, lift up to 25 lbs, and gown for cleanroom access.

Why Join Us?

• Work in a purpose-driven environment focused on innovation and patient impact.
• Contribute to high-value, small-batch clinical production.
• Be part of a supportive, collaborative team with opportunities for growth.