Senior Scientist, R&D, Assay Development

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The Position

We advance science so that we all have more time with the people we love.

Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

The Senior Scientist is responsible for supervising and guiding a team of scientists and/or research associates on Product Care and Quality Team (PCQT projects). This individual will initiate, direct and execute scientific research and/or development strategies through a combination of research staff and individual studies; and provide strategic direction. You will have expertise in infectious diseases and molecular biology techniques, including principles of nucleic acid hybridization, probe and primer design, molecular cloning and technologies for amplification of specific gene sequences

• You will determine a strategic approach to experimental design.

• You will write formal plans/reports in support of FDA clearances.

• You will create and develop new methods to achieve technical objectives; you will anticipate potential problems and design preventative solutions and integrate results with project and division objectives.

• You will maintain a high level of expertise through scientific literature, competitor products, and seminars; communicate the significance of recent developments to peer groups. 

• You will effectively use your  peer network to expand technical capability and may contribute toward or produce invention disclosures, patents and publication.
   

This role is based on-site in Carlsbad, CA and Torrey Pines, CA.
Relocation benefits are not being offered for this position.
 

Who You Are:
(Required):

• You have a Ph.D. in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry or a related field with three (3+) or more years of experience as a scientist in the medical diagnostic arena; or a Masters in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry or a related field with five (5+) years of experience as a scientist in the medical diagnostic arena; or a BS in Biochemistry, Microbiology, Molecular Biology, Analytical Chemistry or a related field with ten (10+) or more years of experience as a scientist in the medical diagnostic arena

• You have demonstrated experience leading or managing projects

• You have demonstrated experience with the development of molecular diagnostics from product concept through FDA clearance including but not limited to: Initial development/feasibility activities; Transfer to Manufacturing; Verification and Validation studies

• You have a proven track record of IVD product development; you have demonstrated ability to formulate and solve problems

• You have a demonstrated mastery in data analysis (including various statistical analyses and DOE), research design, and evaluation of new techniques & procedures for products, systems or technologies.

• You have demonstrated problem-solving, judgment and decision-making skills 
   

Preferred:

• Advanced degree (Ph.D. or Masters) is preferred

• You have demonstrated experience with sample preparation of difficult matrices

• You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities.

• You have strong communication skills including the ability to communicate with all levels within the organization; ability to read, write, and analyze complex documents. 

• You have a high level of familiarity with relevant FDA guidance documents.

• You have strong time management and organizational skills in a dynamic, constantly changing environment; you have the ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.
   

WORK ENVIRONMENT
 

The essential