Scientist Bacteriology

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing clinical chemistry and transfusion medicine. We are more than 6000 strong and do business in over 130 countries providing answers with fast accurate and consistent testing where and when they are needed most home to hospital lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

At QuidelOrtho were advancing the power of diagnostics for a healthier future for all. Join our mission as our next Scientist Bacteriology to support microbiology and biorepository activities critical to diagnostic assay development with a focus on bacterial pathogens and clinical specimen management. This role involves hands-on work with bacterial culture strain qualification and clinical sample processing as well as contributing to assay feasibility validation and repository growth. The ideal candidate will bring strong laboratory skills a proactive mindset and the ability to work in a regulated biosafety-driven environment while collaborating across R&D and cross-functional teams

This position will be onsite full-time in San Diego CA Summers Ridge (Sorrento Valley) HQ.

NOTE: This position is not currently eligible for visa sponsorship.

The Responsibilities

• Designs plans and execution of bacteriology experiments with minimal supervision to support assay development optimization and validation activities
• Leads bacterial culture characterization strain qualification and sample preparation activities in accordance with established protocols and study objectives
• Develop and optimize assay conditions (e.g. lysis methods extraction workflows amplification parameters inclusivity/exclusivity testing) in collaboration with cross-functional teams
• Independently analyzes experimental data interprets findings and provides recommendations to improve assay performance and robustness
• Investigates and troubleshoots assay performance issues related to bacterial targets reagents workflows or instrumentation
• Maintains detailed accurate and well-organized laboratory notebook records in compliance with design control and quality system requirements
• Authors and contributes to technical reports protocols validation documentation and study summaries supporting product development
• Leads or supports feasibility studies inclusivity/exclusivity panels limit of detection (LoD) studies and verification/validation activities
• Contributes to development and qualification of QC standards reference materials and bacteriology-related test methods
• Participates in risk assessments (e.g. FMEA) and supports generation of product design documentation within regulated development environments
• Collaborate with cross-functional partners including Bioinformatics Regulatory Affairs Quality Manufacturing and Supply Chain to support assay development and product readiness
• Supports technology transfer activities and provides technical expertise for bacteriology-related investigations during scale-up or manufacturing support
• Ensures compliance with internal quality systems biosafety standards and applicable regulatory requirements
• Reviews scientific literature and emerging technologies related to bacterial pathogens molecular targets and diagnostic methodologies to inform assay development strategies
• Provides technical guidance and mentorship to laboratory technicians research associates or junior scientists as appropriate
• Maintains a safe laboratory environment and performs other duties as assigned
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelors degree in microbiology molecular biology biochemistry biomedical Sciences or related scientific discipline
• 7-10 years of laboratory experience in bacteriology microbiology or molecular assay development (industry experience preferred)
• Experience working in a regulated environment (e.g. FDA ISO 13485 design control) preferred
• Hands-on experience with bacterial culture strain handling and characterization
• Experience with molecular techniques such as PCR qPCR nucleic acid extraction and assay optimization
• Familiarity with inclusivity/exclusivity studies LoD studies and validation protocols
• Ability to analyze and interpret experimental data using appropriate statistical or analytical tools
• Proficiency in maintaining laboratory documentation in compliance with quality system requirements
• Working knowledge of biosafety practices (BSL-2 MUST)

The Key Working Relationships

Internal Partners:

• R&D / Assay Development Collaborate on experiment execution troubleshooting and assay optimization.
• Bioinformatics Provide feedback on target selection and primer/probe performance.
• Quality Assurance / Regulatory Support validation studies and ensure documentation meets quality and regulatory requirements.
• Manufacturing / QC Assist with technology transfer and investigation of bacteriology-related performance issues.
• Project Management Provide data updates and support project timelines.

External Partners:

• Culture Collection & Reagent Vendors Source and qualify bacterial strains and raw materials.
• Contract Labs / CROs Support external testing and validation activities.
• Instrumentation Suppliers Collaborate on assay compatibility and performance troubleshooting.

The Work Environment

The work environment characteristics are representative of a manufacturing laboratory or warehouse environment and include handling of viral and bacterial hazards potentially hazardous chemicals as well as infectious or potentially infectious bodily fluids tissues and samples. Up to 75% standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

Position requires ability to lift up to 20 lbs. on a regular basis. Walking standing and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education experience knowledge skills geography and abilities of the candidate in addition to internal equity and alignment with market data. At QuidelOrtho it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $100000 to $110000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical dental vision life and disability insurance along with a 401(k) plan employee assistance program Employee Stock Purchase Plan paid time off (including sick time) and paid Holidays. All benefits are non-contractual and QuidelOrtho may amend terminate or enhance the benefits provided as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals including individuals with disabilities have an opportunity to apply for those positions that they are interested in and qualify for without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability please contact us at .

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