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.

The Role

QuidelOrtho is seeking a Senior Scienitst, Product Transfer to support Molecular Diagnostic Assays. This person will be responsible for supporting the transfer and validation of molecular diagnostic assays, assay formulations, QC methods, and testing processes into manufacturing. Drafting finalized transfer documents containing key manufacturing and QC processes for successful transfer of Molecular Diagnostic Assays to Operations Manufacturing and Operations QC. Responsible for development of QC test methods and Gold Stocks for final release of raw materials, sub-assemblies, and final molecular diagnostic products.

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

The Responsibilities

• Acts as a liaison between the company and technical partners that may be established to enhance the results of the research/development projects underway.
• Conducts complex experimentation including data collection, summary, and thorough analysis, in support of department research projects and guidelines. Compose robust experimentation strategies that maximize effective use of resources and time to deliver optimal information.
• Analyzes complex data sets, with understanding of relevant statistical analyses and can present findings to various audiences.
• Participates as an integral member of the scientific staff in formulating research strategy and methodology.
• Provides recommendations and observations to scientific staff and management on results of projects/tasks. Plays a key role in the formulation of research strategies and tactics.
• Is innovative with respect to research methods and product formulation to resolve problems and accomplish company objectives. Pro-actively recommends strategy to overcome hurdles.
• Maintains records of laboratory activities and notebooks in a professional, accurate manner. May provide support to regulatory and intellectual property activities.
• Operates complex laboratory equipment, routine maintenance, and coordinates calibration and repairs. Interfaces with contracted repair technicians as required. Understands theoretical basis for analytical instrumentation.
• Operates equipment and conducts tasks in a safe manner, adhering to established guidelines and applicable regulations.
• Plans, coordinates, trains, and directs the tasks of junior staff assigned to their development projects.
• Responsible for analyses of complex QC development data to establish QC acceptance criteria for final release of product.
• Supports stability studies and quality testing plan for raw materials and/or formulations required for newly developed products, ensuring robust performance.
• Supports investigations and studies of current molecular diagnostic products for continuous improvement initiative.
• Possesses strong technical writing skills to generate verbal and written reports as necessary and to summarize laboratory activities and projects. Initiates communication with related staff and functions as necessary to coordinate activities effectively.
• Contributes scientific leadership and innovation increasingly independent of external direction.
• Assists in the professional and scientific development of junior staff members.
• May represent department and/or company to outside organizations and companies, in conjunction with management.
• Carries out duties in compliance with established business policies.
• Perform other work-related duties as assigned.

The Individual

Required:

• MA/MS in life sciences, similar field or equivalent and at least 8 years of related experience.
• PhD in life sciences, similar field, or equivalent and 5-8 years of related experience.
• Background in chemistry, biochemistry, molecular biology, virology, microbiology, immunology, or related field.
• Biochemical - knowledge and hands-on experience with mathematical calculations pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques, especially qPCR.
• Experience with evaluating and transferring injection molded components and other plastics/consumables into a manufacturing environment desirable.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential.
• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive, and constructive manner.
• Ability to work cross-functionally on multiple projects, in a fast-paced environment to meet aggressive timelines, with ability to adapt as project roles and timelines require.
• Demonstrated skills in carrying out innovative research with minimal guidance in an accurate, effective manner.
• Proven ability to functionally direct junior research staff.
• Proven experience generating research hypotheses, analyzing complex problems and data sets.
• In-depth knowledge of scientific principals and concepts
• 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, and troubleshoot problems
• Strong technical communication skills, written and verbal
• Knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.)
• Knowledge of quality system regulations and processes
• Appropriate computer skills (e-mail, word processing, graphing software, MS Suite)
• Understand theoretical basis for analytical instrumentation
• Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies.

Preferred:

• Knowledge of advanced methods for statistical experimental design and data analysis; JMP statistical analysis experience a plus
• Experience with process and product validations, specification setting, and test method validations, and FDA design control documentation is preferred/a plus.
• Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred.
• Highly experienced in product development and experimental design in biotechnology or pharmaceutical setting preferred.

The Key Working Relationships

Internal Partners:

• Partners closely with 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, and communicate conflicting project goals.
• 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.
• Works with Manufacturing and PMO to set up and coordinate validation lots of devices and consumables.
• Acts as internal consultant and molecular subject matter expert.

External Partners:

• Vendors and customers.

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% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

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 $100,000 to $120,000 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.