The Role
Performs quality control microbiology testing, environmental monitoring, disinfectant efficacy testing, and bioburden and endotoxin assays in a GMP-regulated sterile injectable manufacturing environment. Maintains data integrity, supports method validation, investigations, contamination control, trend analysis, and regulatory compliance. Authors technical documentation, operates laboratory equipment, mentors junior staff, and leads complex testing and validation projects.
Summary Generated by Built In
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 provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique 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, BioTechnique 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 BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your 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 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.
Requirements
- 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.
- Must be authorized to work in the U.S.
- No C2C at this time.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all 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) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- Bachelor's degree in Microbiology, Biology, Biotechnology, Biochemistry, or a related scientific discipline
- 4-6 years of Quality Control Microbiology experience in a regulated pharmaceutical, biotechnology, or related industry
- Knowledge of microbiological testing methods
- Knowledge of environmental monitoring programs
- Knowledge of contamination control principles
- Understanding of cGMP regulations
- Understanding of data integrity requirements and laboratory documentation practices
- Experience with method validation, investigations, and trend analysis
- Strong analytical, problem-solving, organizational, and communication skills
- Ability to manage multiple priorities and work effectively in a team environment
- Leadership and mentoring capabilities for advanced-level positions
- Experience with LIMS, eQMS, or laboratory data systems
- Authorization to work in the United States
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
