Microbiologist

Bio Technique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. Bio Technique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs. The Experience With operations spanning the globe and featuring a multi-cultural team, Bio Technique is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At Bio Technique, it’s about more than just a job—it’s about your career and your future.

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 is responsible for executing laboratory testing, supporting validation activities, maintaining data integrity, and ensuring compliance with cGMP, regulatory, and company quality requirements. Higher levels assume increasing responsibility for project leadership, investigations, method validations, and mentoring junior staff.

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). Experience with 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.

• Bachelor's degree in Microbiology, Biology, Biotechnology, Biochemistry, or a related scientific discipline
• 4-6 years experience 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.
• Ability to work…