Microbiology Supervisor

PSC Biotech® Corporation; York (York County); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) and matching

Paid time off

Education assistance

Employee discounts

Job summary

BioTechnique is seeking a Microbiology Supervisor to oversee the daily operations of the microbiology laboratory, ensuring GMP/GLP compliance and timely testing of materials and finished products. You will lead microbiology staff, review data for accuracy, and drive CAPA investigations to maintain product quality.

The role requires a Bachelor’s in Microbiology (Master’s preferred), 5+ years in a GMP lab, and 2+ years in a supervisory capacity within the pharmaceutical or biotech sector.

Qualifications

• Bachelor's degree in Microbiology or related field required; Master's preferred.
• 5+ years of experience in a GMP-regulated microbiology laboratory.
• 2+ years of supervisory or leadership experience preferred.
• Experience in pharmaceutical/biotechnology/life sciences industry required.
• Strong knowledge of microbiological techniques (environmental monitoring, sterility testing, endotoxin testing).
• In-depth understanding of cGMP, FDA, USP guidelines.

Responsibilities

• Supervise and coordinate day-to-day microbiology lab activities, including environmental monitoring and sterility testing.
• Ensure compliance with cGMP, GLP, FDA, USP and other regulatory requirements.
• Review and approve laboratory data, test results, and documentation for accuracy and completeness.
• Lead investigations for OOS, deviations, and contamination events; implement CAPA.
• Maintain laboratory readiness for internal and external audits and inspections.
• Develop, revise, and approve SOPs, protocols, and reports; train and evaluate staff; support performance management.
• Ensure proper maintenance, calibration, and qualification of equipment.
• Coordinate sample scheduling and ensure timely testing to meet production and release timelines.
• Monitor laboratory inventory, reagents, and supplies.
• Support method validation and method transfer activities; drive continuous improvement.
• Collaborate with Quality Assurance, Manufacturing, and R&D teams.

Skills

GMP Microbiology

Environmental Monitoring

Sterility Testing

Leadership

CAPA Investigation

Education

Bachelor's in Microbiology

Master's preferred

Job description

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 Microbiology Supervisor is responsible for overseeing daily operations of the microbiology laboratory, ensuring compliance with regulatory requirements, and supporting the testing of raw materials, in-process samples, and finished products. This role provides leadership to microbiology staff, ensures timely and accurate results, and maintains adherence to GMP, GLP, and company standards. The incumbent is also responsible and accountable for the execution of the PSC and BioTechnique mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

• Supervise and coordinate day-to-day microbiology laboratory activities, including environmental monitoring, sterility testing, microbial identification, and bioburden testing.
• Ensure compliance with cGMP, GLP, FDA, USP, and other applicable regulatory requirements.
• Review and approve laboratory data, test results, and documentation for accuracy and completeness.
• Lead investigations for out-of-specification (OOS), deviations, and contamination events; implement corrective and preventive actions (CAPA).
• Maintain laboratory readiness for internal and external audits and regulatory inspections.
• Develop, revise, and approve standard operating procedures (SOPs), protocols, and reports. Train, mentor, and evaluate microbiology staff; support performance management and development.
• Ensure proper maintenance, calibration, and qualification of laboratory equipment.
• Coordinate sample scheduling and ensure timely testing to meet production and release timelines.
• Monitor laboratory inventory, reagents, and supplies.
• Support method validation, method transfer, and continuous improvement initiatives.
• Collaborate cross-functionally with Quality Assurance, Manufacturing, and R&D teams.
• Additional duties and responsibilities may be assigned from time to time.

Requirements

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or related scientific discipline required. Master’s degree preferred.
• 5+ years of experience in a GMP-regulated microbiology laboratory.
• 2+ years of supervisory or leadership experience preferred.
• Experience in the pharmaceutical, biotechnology, or life sciences industry is required.
• Strong knowledge of microbiological techniques (e.g., environmental monitoring, endotoxin testing, sterility testing).
• In-depth understanding of cGMP, FDA, USP <61>, <62>, <71>, and other relevant guidelines.
• Proven leadership and team management skills.
• Strong problem-solving and investigation skills.
• Excellent written and verbal communication abilities.
• Ability to manage multiple priorities in a fast-paced environment.
• Detail-oriented with a strong commitment to data integrity and quality.

Demonstrated Competencies

• Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
• Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus.
• Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
• Rational Persuasion – Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
• Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.

Benefits

• 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 Perks and Discounted Rates
• Financial Perks and Discounts

Equal Opportunity Employment Statement

BioTechnique 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.