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 6,000 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.

QuidelOrtho is seeking a Senior to support our R&D team. Responsibilities include research and development activities toward development and validation of new products
and transfer of products and technologies to manufacturing. Responsibilities may also include providing technical support to manufacturing in addressing issues that may or can cause product supply interruptions.

This position will be onsite full-time at our Summers Ridge (San Diego, CA) facility.

The Responsibilities

• Develops scientific plans and approaches, provides technical direction and mentoring to Development Associates
• Accomplishes objectives through sound project management
• Designs experiments to develop and optimize assays
• Identifies and resolves assay performance issues
• Collaborates with internal and external resources
• Summarizes experimental data and draw conclusions independently
• Determines feasibility, process development, validation, creation and implementation of documentation
• Investigates the feasibility of applying a wide variety of scientific concepts to potential products, implements new methods or procedures
• Maintains project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process
• Contributes to formation of statistical experimental design, data analysis and interpretation
• Writes reports, documents, and protocols
• Reviews of relevant literature, creative thinking, and application to problem solving
• Maintains detailed and organized notebook records
• Performs other duties and projects as assigned

The Individual

Required:

• BA/BS in life sciences, similar field or equivalent and 5+ years of related experience
• MA/MS in life sciences, similar field or equivalent and at least 3+ years of related experience
• PhD in life sciences, similar field, or equivalent and 1+ years of related experience
• Background in chemistry, biochemistry, molecular biology, virology, immunology, or related field
• Specific technical skills as defined by management based on anticipated and approved projects in agreement with strategic company goals and objectives
• Knowledge of scientific principals and concepts
• Experience in product development and experimental design
• Knowledge of advanced methods for statistical experimental design and data analysis
• Strong analytical and problem solving skills
• Excellent organizational skills and ability to manage multiple tasks/projects simultaneously
• Ability to plan and execute experiments to:
• Prove feasibility
• Develop new processes and set specifications
• Characterize materials and set specifications
• Troubleshoot problems
• Ability to work within cross-functional teams
• Strong communication skills, written and verbal
• Must exhibit professionalism, confidence, maturity and display desire to succeed, be self motivated and proactive
• Knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.)
• Demonstrate ability to consistently meet proposed objective timelines, apply competent use of project planning and project management skills
• Working knowledge of manufacturing tools and processes
• Knowledge of quality system regulations and processes
• Appropriate computer skills (e-mail, word processing, graphing software)

Preferred:

• Experience working in an FDA regulated environment
• Molecular assay development experience

The Key Working Relationships

Internal Partners:

• peers in Research & Development to address scientific problems and solutions, with Manufacturing to set up and optimize prototype production, with QC staff to optimize downstream testing, and with
  clinical/regulatory as appropriate.
• Provide updates to Management and Project Teams, may participate in cross-functional teams, may lead interdepartmental project team in development of new assay or technology.
• Acts as internal consultant.

External Partners:

• Vendors and customers.

The Work Environment

The work environment characteristics are representative of a laboratory, or office 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% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. 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 $85,000 to $110,000 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 recruiting@quidelortho.com.