Senior Microbiologist

Actalent • Sanford, NC • 2w ago

Job Title: PhD Microbiology Senior Scientist - Pharmaceutical Microbiology (Endotoxin, Bioburden, Sterility, Method Development & Validation)Position Summary

We are seeking a highly skilled and motivated Senior Scientist to join our Quality Control Method Transfer and Validation team, with a specialized focus on microbiological testing in a GMP-regulated pharmaceutical environment. This role will be instrumental in developing, validating, and transferring microbiological methods-particularly for endotoxin, bioburden, and sterility testing-to support the release and stability testing of biologics and sterile products.

Key Responsibilities

Independently design, execute, and interpret microbiological experiments related to endotoxin (LAL), bioburden, and sterility testing.

Draft and review method validation protocols and reports in compliance with USP, EP, JP, and cGMP guidelines.

Lead method development and optimization efforts for microbiological assays, ensuring robustness, reproducibility, and regulatory compliance.

Collaborate with cross-functional teams to support method transfer activities and troubleshoot microbiological issues.

Perform data analysis and trending to support investigations, CAPAs, and continuous improvement initiatives.

Author technical documentation including SOPs, validation protocols, and summary reports.

Evaluate and implement new technologies and instrumentation for microbiological testing.

Provide mentorship and technical guidance to junior scientists and lab analysts.

Required Qualifications

BS in Microbiology, Biology, or related field with 10+ years of industry experience; MS with 8+ years; or PhD with 4+ years.

Proven expertise in endotoxin (gel-clot, kinetic chromogenic/turbidimetric), bioburden, and sterility testing.

Strong understanding of method validation principles (accuracy, precision, specificity, robustness, etc.).

In-depth knowledge of GMP, data integrity, and regulatory expectations for microbiological testing.

Experience with method transfer, including drafting protocols and managing inter-lab comparisons.

Preferred Skills

Experience with LIMS

Strong technical writing and data interpretation skills.

Ability to manage multiple projects and prioritize tasks in a fast-paced environment.

Work Environment

This position is based in a state-of-the-art pharmaceutical manufacturing facility focused on vaccines, gene therapies, and monoclonal antibodies. The team operates in a collaborative, quality-driven culture with opportunities to work on high-impact projects and receive training in advanced microbiological techniques. Standard work hours are Monday to Friday, 8 AM to 5 PM, with occasional weekend work as needed.

Pay and Benefits

The pay range for this position is $60.00 - $65.00/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 Sanford,NC.

Application Deadline

This position is anticipated to close on May 23, 2025.

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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