Scientist - Molecular Development Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: R & D Molecular
Quidel has a temporary/contract opportunity for a Scientist. As a Scientist on our growing molecular team, you will have the opportunity to drive R&D activities for the development and validation of new molecular diagnostics products, and for the transfer of products and technologies to manufacturing. Though the majority of your time is on the bench, the Scientist will participate in cross-functional teams to include R&D, Management, Manufacturing and QC for addressing scientific problems and solutions, setting up and optimizing prototype production, and optimizing downstream testing. The Scientist?s responsibilities may also include providing technical support to manufacturing regarding issues that may or can cause product supply interruptions. The successful candidate must have industry experience with a product that has gone from the development phase to the manufacturing phase within a highly regulated, ISO, GMP, FDA environment.
Primary Responsibilities Include: ? Evaluate Molecular Diagnostics Kits and Reagents ? Design experiments to develop and optimize assays to be used in our molecular diagnostic tests ? Identify and resolve assay performance issues ? Develop scientific plans and approaches ? Summarize experimental data and draw conclusions independently ? Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process ? Determine feasibility, process development, validation, creation and implementation of documentation, and training of personnel ? Provide updates to Management and Project Teams on an on-going basis ? Participate in cross-functional teams and potentially lead interdepartmental project teams in development of new assay or technology
? BA/BS (Ph.D. preferred) in life sciences; and/or relevant experience in chemistry, biochemistry, molecular biology, virology, immunology, or a related field ? 7+ years progressively increasing levels of responsibility ? Proven experience in Nucleic Acid Extraction and Real Time PCR and associated analysis ? Experience with isothermal amplification a plus ? Enzyme assay design and interpretation ? Working knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.) ? Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts, FMEA) ? Knowledge of related quality system regulations and process ? Excellent written and verbal communication skills ? Must exhibit professionalism, confidence, maturity and display desire to succeed, be self-motivated and proactive ? Demonstrated ability to consistently meet proposed objective timelines, applying competent use of project planning and project management skills
Quidel is proud to be an Equal Opportunity/Affirmative Action Employer (M/F/D/V).
||San Diego, CA |
THIS JOB HAS EXPIRED