Assistant Manager, Microbiology Services

About the Role

Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We support clients in the pharmaceutical, biotech, and medical device fields. This full-time, onsite, exempt position reports to the Microbiology Services Manager and combines hands-on technical expertise with leadership responsibilities in a regulated cGMP/GLP environment.

Responsibilities

• Service Responsibilities To Clients
  • Develop, implement, and maintain processes that ensure exceptional client service, timely study execution, and compliance with established quality and turnaround-time standards.
  • Partner with clients and internal stakeholders to support specialized study development, scheduling, execution, reporting, and resolution of technical or service-related issues.
  • Ensure client concerns and complaints are addressed promptly and in accordance with applicable Pacific BioLabs SOPs.
  • Lead departmental and cross-functional initiatives to enhance client satisfaction, operational efficiency, and service quality.
• Service Responsibilities To Internal Customers
  • Collaborate with the Microbiology Services Manager and other departments to ensure studies are conducted efficiently, accurately, and in compliance with applicable quality and regulatory requirements.
  • Ensure microbiology staff have the personnel, equipment, training, and resources necessary to successfully complete testing activities within a cGMP/GLP-regulated environment.
  • Coordinate with Quality Assurance, Administrative Services, and other functional groups to address regulatory, reporting, billing, and operational matters.
  • Foster a collaborative, team-oriented culture and lead initiatives that improve departmental effectiveness and overall laboratory performance.
• Technical Responsibilities
  • Serve as a subject matter expert on microbiological testing standards, including USP, European Pharmacopoeia, and AAMI requirements relevant to pharmaceutical and medical device testing.
  • Maintain expertise in applicable cGMP, GLP, and laboratory quality system requirements.
  • Oversee and support routine and specialized microbiology studies, including study scheduling, preparation, execution, data review, and report approval.
  • Lead the development, review, implementation, and continuous improvement of department SOPs, test methods, and study protocols.
• Administrative Responsibilities
  • Comply with Pacific BioLabs policies, SOPs, and regulatory requirements related to documentation, reporting, training, and client communications.
  • Participate in and support ongoing training, compliance, and quality improvement initiatives.
• Leadership Responsibilities
  • Communicate departmental priorities, organizational objectives, and performance expectations to microbiology staff.
  • Ensure that client service is given top priority by all microbiology staff.
  • Coordinate and direct departmental activities related to testing, training, study execution, data review, and reporting.
  • Establish departmental and individual performance goals and monitor progress toward completion.
  • Monitor departmental performance and communicate significant operational, staffing, or quality concerns to the Microbiology Manager.
  • Oversee onboarding, training, and development activities for microbiology staff.
  • Support laboratory equipment maintenance, calibration, and operational readiness activities.
  • Conduct annual performance evaluations of all department staff.

Requirements

• Education/Experience
  • Bachelor's degree or higher in Microbiology, Biological Sciences, or a related discipline required.
  • Advanced knowledge of current guidelines for microbiological and sterility assurance testing of medical devices and pharmaceuticals required, including USP, European test methods, and AAMI guidelines.
  • Minimum of 4 years of microbiology laboratory experience in the pharmaceutical, medical device, CRO, biotechnology, or related life sciences industry required.
  • Prior leadership, supervisory, project management, or team lead experience strongly preferred.
• Technical Skills
  • General Skills/Scientific Aptitude:
    • Advanced math and computer skills required.
    • Solid grasp of advanced scientific language and current industry standards and practices required.
    • Critical thinking skills appropriate for advanced problem-solving activities required.
    • Intellectual aptitude for analyzing data and drawing conclusions based on current guidelines, SOPs, etc.
  • Specific Laboratory Skills:
    • Proficient in all laboratory skills required of Microbiology Analysts, including aseptic technique, serial dilutions, gram staining procedures, and preparation of test media.
    • Proficient in microorganism culturing techniques and basic biochemical characteristic evaluation, as well as operation of sterilization equipment.
    • Proficient in bioburden recovery, radiation dose setting, and cleaning-disinfection validation procedures.
• Interpersonal Skills
  • Excellent language and communication skills required; must be able to clearly communicate priorities and responsibilities on a daily basis.
  • Solid leadership skills required; must be able to give directions clearly, build consensus, effectively manage priorities, and unite diverse individuals in pursuit of common goals.
  • Must be capable of working with persons from diverse backgrounds.
• Physical Abilities
  • Requires frequent use of hands, arms, and manual dexterity to perform laboratory procedures and operate laboratory equipment.
  • Must be able to wear required personal protective equipment (PPE).
  • Must be able to occasionally lift and move materials weighing up to 25 pounds.
  • Must be capable of working at a lab bench for up to three hours at a time, and for up to eight hours on a given day.
  • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day.

Pay

The pay range for this position is $95,000 to $125,000 annually. The base pay offered will take into account internal equity and may vary depending on the candidate’s job-related knowledge, skills, and experience.

Benefits

This position is eligible for medical, dental, vision, life insurance, 401k, and other benefits.