Senior Development Scientist

Cepheid Sacramento , CA 94204

Posted 2 months ago

The Senior Development Scientist leads the development and execution of new product designs, processes, feasibility studies, scale-up experiments, technology transfer to production, and process/product validation activities. The position includes laboratory and desk roles to develop complex diagnostic laboratory workflows for multiple R&D programs in microbiology, ensuring that product performance and regulatory requirements are demonstrated through the planning, execution, and data management of studies. The role will be responsible for the creation and documentation of detailed product specifications and instructions for product use in clinical microbiology laboratories employing diagnostic procedures including antibiotic susceptibility testing and microbial identification.

Operational activities supporting these development responsibilities require strong cross-functional collaboration. Deliverables include: development of complex microbial assays consisting of reagents, assays and instrumentation, evaluation of available technologies and protocols in clinical laboratories, product compatibility testing against customers' requirements, study designs based on clinical experience and/or knowledge of customer/patient needs. The position is in the Research and Development group which is responsible for reagent and assay development on our Microbial diagnostic platform.

Essential Job Responsibilities:

  • Development and optimization of assays, reagents, sample preparation methods and protocols for in vitro diagnostic tests

  • Characterization of infectious organism's antibiograms, drug resistance mechanisms and biological nature of variance in resistance under various environmental conditions

  • Maintenance of detailed experimental records and laboratory documentation

  • Authorship of technical reports, SOPs and supporting quality documentation

  • Design of training and troubleshooting materials to assist assay transfer to manufacturing

  • Surveillance of technology and competitive trends in Medical Microbiological Diagnostics

  • Application of strategies and analytical problems solving skills to reagent and system integration issues to identify critical performance factors of microbiology and chemistry assays

  • Presentation of data at technical meetings

  • Efficient allocation and prioritization of time and resources to meet individual, team, and corporate goals

The ideal candidate must have a background primarily in clinical microbiology and biochemistry. Success in this position will require:

  • Experience in clinical microbiology assays, reagent preparation methods and test protocols including experience working with clinical specimens.

  • Demonstrated ability to write, present and communicate verbally in a clear manner.

  • Able to work independently and in a multidisciplinary team-based environment of scientists and engineers.

  • Ability to perform knowledge discovery and analysis of technical research publications as it applies to product development

  • Take initiative and lead when necessary to work through complex, cross-functional project issues with aggressive timelines

  • Understanding of good laboratory technique and documentation practices

  • Attention to detail and methodical problem solving skills

  • Expertise in molecular biology techniques and instrumentation used for chemical and protein analysis

  • Knowledge of microscopy techniques and image analysis methods preferred

  • Experience in development of reagent preparation methods and analytical test protocols

  • Expertise in working with medically important strains of bacteria and yeasts preferred

  • Knowledge of application of Lean, 6-sigma, Kaizen and 5S principles to problem solving and continuous improvement

  • Experience with statistical methods and programs (JMP, SAS, R) necessary for successful data analysis and interpretation including DOE, and process and test method validation

  • Working with ISO and GMP quality systems with demonstrated experience working in BSL-2 laboratory environment preferred

Educational Requirements:

Bachelor's degree in field with 5 years of experience OR Master's degree in field with 3 years of experience OR Doctoral degree in field with 0-2 years of experience.

Diversity & Inclusion

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page

Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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Senior Development Scientist

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