Quality Control Laboratory Microbiologist I

Job Title: Quality Control MicrobiologistJob Description

The Quality Control Microbiologist will support a new commercial cell therapy production center by performing microbiological testing and environmental monitoring to ensure product quality and patient safety. This role focuses on product testing, utility testing, and comprehensive environmental monitoring within a cutting-edge GMP cell therapy manufacturing environment advancing innovative treatments for autoimmune diseases.

Perform environmental and utility monitoring and sampling as a primary function, including routine collection of facility and utility system samples in accordance with SOPs.

Conduct routine and non-routine inspection of media fill samples (AOQ/APV), and perform collection and testing of media, final product, validation-related, and critical utility samples following established procedures.

Receive, quarantine, and store purchased microbiological media pending laboratory release, ensuring proper documentation and compliance with quality standards.

Monitor biohazardous waste and coordinate its safe removal with qualified safety personnel in alignment with regulatory and internal safety requirements.

Participate in validation activities and support commercial and developmental manufacturing operations by providing microbiology and environmental monitoring expertise.

Review and issue Environmental Notifications based on raw data and validated electronic data acquisition systems, ensuring accurate interpretation and timely communication of results.

Represent Quality Control for microbiology and environmental monitoring in site meetings, providing technical input and supporting cross-functional decision-making.

Support testing of solid oral dosage forms, packaging component testing, raw material testing, and sterile product testing as needed.

Troubleshoot standard instrumentation and test methods, resolving technical issues and supporting continuous improvement of laboratory processes.

Perform activities in support of final product release testing, including assays for endotoxin, sterility, and particle isolation, as well as raw material testing such as media growth promotion.

Conduct environmental monitoring activities including surface viable air sampling, non-viable air monitoring, and personnel monitoring in controlled areas and cleanrooms.

Perform bioburden testing of water and product, and monitor viable and non-viable particles and moisture levels in compressed gases and air systems.

Write deviations and standard operating procedures (SOPs), and contribute to change control and validation documentation to ensure compliance with ICH, FDA, USP, and other regulatory requirements.

Provide technical training on environmental monitoring of facilities and utility systems, helping team members understand compliance requirements and the impact of their work on product quality.

Work both independently and as part of cross-functional project teams to support Phase 3 and BLA-related activities and contribute to building out the QC microbiology function as the site moves toward commercialization.

At least 2 years of relevant experience in microbiology, quality control, or a related laboratory discipline.

Associate's or Bachelor's degree in microbiology, biology, chemistry, or a related scientific field.

Hands-on quality control microbiology experience, including environmental monitoring and utility testing in a GMP setting.

Practical experience with environmental monitoring in cleanrooms, including air sampling, surface sampling, and personnel monitoring.

Knowledge of general microbiology techniques such as gram staining and plate streaking.

Experience with sterility testing, bioburden testing, and media growth promotion testing.

Understanding of compliance documentation and regulations, including GMP, GLP, and relevant regulatory standards.

Ability to perform gas and water testing and interpret microbiological data for utilities.

Capability to troubleshoot standard laboratory instrumentation and test methods.

Ability to work effectively in a team environment while also managing individual responsibilities and projects.

Prior experience in the biopharmaceutical or pharmaceutical industry, particularly in a GMP manufacturing or QC laboratory setting.

Previous laboratory experience performing microbiological assays and environmental monitoring.

Basic knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) applied on a daily basis.

Knowledge of USP and other regulatory requirements relevant to microbiology and environmental monitoring.

Familiarity with ICH and FDA regulations and an understanding of how they impact QC processes and product quality.

Knowledge of HPLC and UPLC systems and their role in analytical testing within a QC environment.

Proficiency in Microsoft Office applications for data analysis, reporting, and documentation.

Experience with MODAL/LIMS or similar laboratory information management systems for sample tracking and data management.

Technical training or experience in environmental monitoring of facilities and utility systems.

Ability to write deviations, SOPs, and other quality documents at a high level, contributing to validation activities and continuous improvement.

Demonstrated ability to train and educate colleagues on structured processes, change control, and compliance practices.

Comfort working in a fast-paced, rapidly growing biotech environment and contributing to Phase 3 and BLA/commercial readiness activities.

Motivation to develop new skills and progress into future roles as the QC and manufacturing teams expand toward commercialization.

This role is based in both office space and GMP manufacturing suites within a commercial cell therapy production center. You will work in controlled cleanroom environments that require strict adherence to aseptic technique, environmental monitoring protocols, and compliance with GMP and GLP standards. The position involves hands-on work in laboratories and production areas with exposure to cell therapy manufacturing, utilities (water, gases, compressed air), and biohazardous materials managed under robust safety procedures. You will collaborate closely with cross-functional teams, participate in regular team meetings and one-on-one check-ins, and engage in structured training and validation activities. The environment is fast-paced, highly regulated, and focused on innovation, offering the opportunity to gain extensive experience in Phase 3 and BLA-stage cell therapy manufacturing while contributing to the build-out of a growing QC microbiology team.

This is a Contract position based out of Frederick, MD.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Application Deadline

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 20,000 consultants and 5,000 clients across the U.Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email View email address on click.appcast.io of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.