Lead Microbiologist

Job Title: Lead MicrobiologistJob Description

We are seeking a skilled and experienced Lead Microbiologist to oversee aseptic microbiological testing of raw materials, in-process materials, and finished products. The candidate will ensure compliance with USP agar methods, SOPs, and GMP regulations, handle live microbiological agents, and perform growth promotion testing. The role involves collecting and analyzing environmental monitoring samples and reviewing laboratory data to ensure accuracy and regulatory compliance.

Responsibilities

• Oversee microbiological testing of raw materials, in-process materials, and finished products in line with SOPs and GMP regulations.

• Handle live microbiological agents and perform growth promotion testing.

• Collect and analyze environmental monitoring samples, including USP Purified Water, soft water, air, and equipment surfaces.

• Review and approve laboratory data for accuracy, completeness, and compliance with regulatory standards.

• Participate in Out-of-Specification (OOS) investigations, deviations, and Corrective and Preventive Actions (CAPAs).

• Calibrate, operate, and maintain laboratory instrumentation used in product testing.

• Supervise and mentor a team of four microbiology technicians, providing training and guidance.

• Assign daily tasks and monitor progress to ensure timely completion of testing and documentation.

• Serve as the primary point of contact for technical questions and troubleshooting.

• Ensure adherence to cGMP, USP, and internal SOPs across all microbiology activities.

• Evaluate data for trends and contribute to the development and revision of SOPs and microbiological test methods.

• Support internal and external audits by providing documentation and subject matter expertise.

• Drive process improvements to enhance efficiency, accuracy, and compliance within the microbiology lab.

• Complete administrative documentation and support lab investigations as needed.

• Communicate effectively with other shifts and departments regarding special testing requirements and relevant issues.

• Assist with inventory management and ensure adequate lab supplies are maintained.

Essential Skills

• Bachelor of Science in Microbiology, Biology, Biochemistry, or related field.

• Strong understanding of scientific principles and logical problem-solving.

• Ability to read, interpret, and follow technical data and SOPs.

• Excellent math and reasoning skills; detail-oriented and highly organized.

• Effective verbal and written communication skills.

• Familiarity with various microbiological testing apparatus.

Additional Skills & Qualifications

• Advanced degree (Master's) in Microbiology or related field is preferred.

• Additional certifications in Quality Control or Microbiology techniques are a plus.

• Industry exposure in pharmaceutical and drug development processes.

• Experience with over-the-counter (OTC) medications.

• Core skills in contamination control, sterility assurance, and regulatory compliance.

• Proficiency in relevant computer software and laboratory systems.

• Self-motivated with the ability to work independently.

Work Environment

The position operates on an 8am - 5pm shift, with flexibility to interface with our 3-shift operation. You will lead a team of four microbiology technicians, fostering a culture of safety, compliance, and continuous improvement.

Job Type & Location

This is a Contract to Hire position based out of Sharonville, OH.

Pay and Benefits

The pay range for this position is $43.00 - $43.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Sharonville,OH.

Application Deadline

This position is anticipated to close on Jan 28, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.