Supervisor, Microbiology

About the role

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner, we provide a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes. We play a vital role in the global pharmaceutical industry by helping to develop molecules today that can become the life-changing therapies of tomorrow.

The Supervisor Microbiology reports to the Director of Quality Control and provides leadership to the microbiology laboratory through all phases of development. This role is responsible for managing the microbiological evaluation of raw materials, components, drug product intermediate, finished drug product, and stability samples, as well as managing the environmental monitoring and aseptic process simulation programs. The position requires working in development and regulated environments, including adherence to cGMPs, regional and country-specific regulations, and internal SOPs.

Responsibilities

• Oversee microbiological testing activities for several of the following functions but not limited to raw material, component, drug product, stability, validation, investigational, and in-process testing.
• Oversee environmental monitoring, aseptic process simulation, and gowning qualification programs.
• Serve as a subject matter expert for microbiology.
• Lead, guide, and mentor analysts to foster a culture of continuous improvement.
• Ensure the laboratories are clean, organized, compliant, and audit-ready at all times.
• Support formulation, process development, and scale-up activities.
• Review and approve laboratory data for accuracy and completeness.
• Lead and serve on cross-functional project teams.
• Prepare protocols, technical reports, and other documentation for CMC-related activities.
• Identify and resolve project-related issues that have the potential to impact project deliverables.
• Ensure compliance of laboratory personnel and equipment.
• Prepare annual laboratory budgeting.
• Perform annual performance assessments of direct reports.

Requirements

• Bachelor’s degree in biology or a related science.
• 8-10 years of experience in a pharmaceutical laboratory management role.

Skills

• Strong knowledge of SOPs, laboratory procedures, FDA and ICH guidance, USP regulations, microbiological testing techniques, and cGMP.
• Strong track record of leadership skills and influence.
• Strong interpersonal skills and ability to build effective and constructive relationships.
• Ability to work cross-functionally both internally and externally.
• Proven leadership, mentorship, and ability to develop a high-performing team.
• Excellent written and verbal communication skills, management skills, strong work ethic, and organizational skills.
• Demonstrated analytical and problem-solving skills.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

About August Bioservices

At August Bioservices, our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard and an everyday measuring stick of our advancement. We aspire to unlock the potential in every person, every process, and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred, and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.