Microbiologist

About the Company

BioTechnique is a sterile injectable full-service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we offer formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create process designs tailored to our clients’ needs.

The BioTechnique experience spans global operations with a multicultural team passionate about collaboration, professional growth, and nurturing talent. We focus on coaching and developing the next generation of industry leaders, offering tools for growth alongside competitive compensation and benefits.

About the Role

The Microbiologist performs microbiological testing, environmental monitoring (EM), detection, enumeration, and testing (DET) activities to support manufacturing operations and product quality within a GMP-regulated environment. This role executes laboratory testing, supports validation activities, maintains data integrity, and ensures compliance with cGMP, regulatory, and company quality requirements. Higher levels assume increasing responsibility for project leadership, investigations, method validations, and mentoring junior staff.

Responsibilities

• Perform microbiological testing, sampling, and laboratory analyses in accordance with approved SOPs.
• Execute Environmental Monitoring (EM) activities, including viable and non-viable air, surface, and personnel monitoring.
• Perform Disinfectant Efficacy Testing (DET).
• Conduct bioburden, endotoxin, and related microbiological assays on client samples.
• Set up, operate, and maintain laboratory equipment and instrumentation.
• Perform and document method validations, qualifications, and trend analyses.
• Review, analyze, and accurately document testing results while maintaining data integrity.
• Report and participate in investigations related to OOS, OOT, and atypical results.
• Support contamination control, GMP compliance, and laboratory continuous improvement initiatives.
• Author, review, and execute protocols, reports, and technical documentation.
• Train, mentor, and provide technical guidance to junior microbiologists and laboratory personnel.
• Lead complex testing, validation, and laboratory projects.
• Follow all safety procedures and wear required PPE.

Requirements

• Bachelor's degree in Microbiology, Biology, Biotechnology, Biochemistry, or a related scientific discipline.
• 4-6 years of Quality Control Microbiology experience within a regulated pharmaceutical, biotechnology, or related industry.
• Knowledge of microbiological testing methods, environmental monitoring programs, and contamination control principles.
• Understanding of cGMP regulations, data integrity requirements, and laboratory documentation practices.
• Experience with method validation, investigations, and trend analysis preferred.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities and work effectively in a team environment.
• Demonstrated leadership and mentoring capabilities for advanced-level positions.
• Experience with LIMS, eQMS, or laboratory data systems is preferred.
• Must be authorized to work in the U.S. (No C2C at this time).

Benefits

• Medical, Dental, and Vision: 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
• 401(k) with company matching.
• PTO, Sick Time, and Paid Holidays.
• Education Assistance.
• Pet Insurance.
• Fitness Benefits (membership discounts and perks at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
• Financial Perks and Discounts.