Associate Scientist – Manufacturing Transfer Specialist

Full Time
San Diego, CA
Posted
Job description
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.

We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!

Quidel is looking for a Associate Scientist to join our R&D team in the Sorrento Valley area of San Diego. Responsibilities will include research and development activities toward development and validation of point-of-care diagnostic products from feasibility through validation and transfer of products to manufacturing. The ideal candidate will have lateral flow development experience. Responsibilities may also include providing minimal technical support to manufacturing in addressing issues that may or can cause product supply interruptions.

ESSENTIAL FUNCTIONS

    • Lateral flow development
    • Bioassays, antibody conjugation, fluorescent labeling
    • Experience with analytical, physical, inorganic, and organic chemistry laboratory procedures, techniques and equipment
    • Develop point-of-care diagnostic products from feasibility through validation and transfer to manufacturing as part of a multidisciplinary project team
    • Execute experimental plans and following SOPs or work instructions for in vitro diagnostic assays under the supervision of senior scientists
    • Analyze data and draft technical reports
    • Maintains detailed and organized notebook records in accordance with internal Quidel and external regulatory requirements as part of the design control process
    • Optimize and integrate immunoassays with in-house platform following the immunoassay development process
    • Coordinate with other lab members day-to-day lab activities including equipment maintenance, reagent orders, restocking consumables, etc.
    • Supports development of QC standards and test methods
    • Maintains a safe working environment, training, carries out duties in compliance with established business policies, remain current with appropriate scientific literature
    • Performs other duties and projects as assigned

EDUCATION AND EXPERIENCE

    • Bachelor’s degree in business administration, life sciences and/or 4 years of relevant industrial experience
    • Prior experience in IVD product development required
    • Familiar with Quality Management System (QMS) such as Master Control

KNOWLEDGE AND SKILLS

    • 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
    • Strong analytical and problem solving skills
    • Good organizational skills and ability to manage multiple tasks simultaneously
    • Ability to plan and execute experiments to: prove feasibility, develop new processes and assist in setting specifications, characterize materials and set specifications
    • Troubleshoot problems
    • Ability to work within cross-functional teams
    • Strong communication skills, written and verbal
    • Must exhibit professionalism, maturity and display desire to succeed, be self-motivated and proactive
    • Working 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)
    • Must be able to resolve moderately complex technical problems semi-independently
    • Must possess ability to develop experimental plans and execute associated activities per communicated timelines
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Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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