Microbiologist Leadership Position for Biopharmaceuticals

3 days ago


Mahwah, New Jersey, United States Joulé Full time

Overview

Joulé is seeking an experienced Microbiologist to lead our QC Microbiology department, responsible for ensuring compliance with cGMP regulations and quality standards.

About the Role

This leadership position requires a strong understanding of microbiological test methods, philosophies, method validation, and transfer. The successful candidate will have a proven track record in managing teams, leading projects, and driving process improvements.

Key Responsibilities

  • Develop and implement effective strategies to ensure compliance with regulatory agency requirements, including 21CFR 210/211, 21CFR 610, 21CFR 1271, and EU Annex 1.
  • Lead and manage the QC Microbiology team, providing technical guidance and oversight to ensure accurate test performance and compliance with quality systems.
  • Collaborate with cross-functional teams to develop and maintain Key Performance Indicators (KPIs) for laboratory testing.
  • Supervise and train employees, promoting a culture of continuous improvement and quality excellence.
  • Interface with regulatory agency inspectors and auditors to ensure compliance with GMP regulations.
  • Participate in Business Development initiatives to attract new clients and generate revenue.
  • Author and revise Standard Operating Procedures (SOPs), Work Instructions, Forms, and Protocols to reflect current practices.

Requirements

We are looking for a highly motivated and experienced Microbiologist with:

Bachelor's or Master's degree in Microbiology or a relevant field.Minimum 7-10 years of experience in environmental monitoring or within the biopharmaceutical industry.Proven track record in leading teams, managing projects, and driving process improvements.Strong knowledge of quality systems, including Deviation/CAPA/Change Control.Familiarity with cGMP regulations and FDA Guidance on Sterile Drugs Produced by Aseptic Processing.Excellent communication and leadership skills.

What We Offer

Joulé offers a competitive salary range of $120,000 - $180,000 per year, depending on experience, plus additional benefits such as health insurance, retirement plan, and paid time off.

Estimated Salary: $150,000

Location: Mahwah, NJ area



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