Description:
Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently hiring to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science!
PBL has an immediate opening for a Microbiology Services Assistant Manager. This is a full-time, onsite, exempt position reporting to the Microbiology Services Manager. The Assistant Manager supports laboratory operations, quality systems, staff development, and client service activities in a regulated cGMP/GLP environment. This role combines hands-on technical expertise with leadership responsibilities and offers opportunities for professional growth and advancement within the department. The position supervises Microbiology Analysts and Technicians and assists with staff development, performance management, and operational planning.
RESPONSIBILITIES FOR THE MICROBIOLOGY SERVICES ASSISTANT MANAGER INCLUDE BUT ARE NOT LIMITED TO:
SERVICE RESPONSIBILITIES TO CLIENTS
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Develop, implement, and maintain processes that ensure exceptional client service, timely study execution, and compliance with established quality and turnaround-time standards.
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Partner with clients and internal stakeholders to support specialized study development, scheduling, execution, reporting, and resolution of technical or service-related issues.
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Ensure client concerns and complaints are addressed promptly and in accordance with applicable Pacific BioLabs SOPs.
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Lead departmental and cross-functional initiatives to enhance client satisfaction, operational efficiency, and service quality.
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
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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.
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Ensure microbiology staff have the personnel, equipment, training, and resources necessary to successfully complete testing activities within a cGMP/GLP-regulated environment.
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Coordinate with Quality Assurance, Administrative Services, and other functional groups to address regulatory, reporting, billing, and operational matters.
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Foster a collaborative, team-oriented culture and lead initiatives that improve departmental effectiveness and overall laboratory performance.
TECHNICAL RESPONSIBILITIES
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Serve as a subject matter expert on microbiological testing standards, including USP, European Pharmacopoeia, and AAMI requirements relevant to pharmaceutical and medical device testing.
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Maintain expertise in applicable cGMP, GLP, and laboratory quality system requirements.
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Oversee and support routine and specialized microbiology studies, including study scheduling, preparation, execution, data review, and report approval.
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Lead the development, review, implementation, and continuous improvement of department SOPs, test methods, and study protocols.
ADMINISTRATIVE RESPONSIBILITIES
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Comply with Pacific BioLabs policies, SOPs, and regulatory requirements related to documentation, reporting, training, and client communications.
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Participate in and support ongoing training, compliance, and quality improvement initiatives.
LEADERSHIP RESPONSIBILITIES
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Communicate departmental priorities, organizational objectives, and performance expectations to microbiology staff.
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Ensure that client service is given top priority by all microbiology staff.
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Coordinate and direct departmental activities related to testing, training, study execution, data review, and reporting.
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Establish departmental and individual performance goals and monitor progress toward completion.
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Monitor departmental performance and communicate significant operational, staffing, or quality concerns to the Microbiology Manager.
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Oversee onboarding, training, and development activities for microbiology staff.
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Support laboratory equipment maintenance, calibration, and operational readiness activities.
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Conduct annual performance evaluations of all department staff.
Requirements:
EDUCATION/EXPERIENCE
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Bachelor's degree or higher in Microbiology, Biological Sciences, or a related discipline required.
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Advanced knowledge of current guidelines for microbiological and sterility assurance testing of medical devices and pharmaceuticals required. Must be well-versed in both USP and European test methods, as well as AAMI guidelines.
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Minimum of 4 years of microbiology laboratory experience in the pharmaceutical, medical device, CRO, biotechnology, or related life sciences industry required.
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Prior leadership, supervisory, project management, or team lead experience strongly preferred.
TECHNICAL SKILLS
General Skills/Scientific Aptitude:
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Advanced math and computer skills required.
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Solid grasp of advanced scientific language and current industry standards and practices required.
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Critical thinking skills appropriate for advanced problem-solving activities required.
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Intellectual aptitude for analyzing data and drawing conclusions based on current guidelines, SOPs, etc.
Specific Laboratory Skills:
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Must be proficient at all of the laboratory skills required of Microbiology Analysts in the department. This includes aseptic technique, serial dilutions, gram staining procedures, and preparation of test media. This also includes microorganism culturing techniques and basic biochemical characteristic evaluation, as well as operation of sterilization equipment. The Assistant Manager should also be proficient at bioburden recovery, radiation dose setting, and cleaning-disinfection validation procedures.
INTERPERSONAL SKILLS
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Excellent language and communication skills required. Must be able to clearly communicate priorities and responsibilities on a daily basis.
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Solid leadership skills required. Must be able to give directions clearly. Must be able to build consensus, effectively manage priorities, and unite diverse individuals in pursuit of common goals.
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Must be capable of working with persons from diverse backgrounds.
PHYSICAL ABILITIES
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Requires frequent use of hands, arms, and manual dexterity to perform laboratory procedures and operate laboratory equipment.
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Must be able to wear required personal protective equipment (PPE).
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Must be able to occasionally lift and move materials weighing up to 25 pounds.
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Must be capable of working at lab bench for up to three hours at a time, and for up to eight hours on a given day.
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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.
The pay range for this position is $95,000 to $125,000 annually. The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.
PBL is an equal opportunity employer committed to diversity and inclusion. PBL considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans’ status, or any other legally protected factors.
