Senior Development Process Scientist

Position Summary

The RSS Development Process & Support team is in need of a Senior Development Process Scientist who will participate in the development and adoption of laboratory, quality system, and design control processes.

The scientist will author, review, manage, and implement processes for IVD product development laboratories, reagent, and assay development activities.  In addition, the individual will provide subject matter expertise to internal R&D teams on best practices, methods, and tools. The scientist will support activities to harmonize and improve quality management system, laboratory, and design control processes.

Experience in next generation sequencing, assay, or reagent product development with demonstrated knowledge in quality management systems, Good Laboratory Practices, Good Documentation Practices, ISO 13485:2016, IVD-R, and Quality System Regulations is highly desired.  The successful candidate is technically proficient, creative, collaborates well with others, can manage complexity and ambiguity, and thinks independently. Attention to detail and excellent writing skills are essential.

Must be able to travel to laboratories at other Bay Area locations on a regular basis.

Responsibilities

• Ensures processes are compliant with relevant standards (e.g ISO 13485:2016, IVD-R, QSR 21 CFR 820, GxP)

• Authors standard operating procedures, plans, and related documentation

• Collaborates with Quality team and Instrumentation and Lab Support teams on audit readiness activities.  May participate in audits to represent Development Team as a subject matter expert on relevant processes.

• Generates training material and conducts trainings for Development scientists and engineers.

• Engages in complex problem solving in close collaboration with Quality team and Product Development scientists and engineers.  Scope of work involves a wide range of problems where original contributions are required. Creative, imaginative thinking is required.

• Influences others - articulates ideas, strategies, and results effectively to peers and management to obtain buy-in and support.

• Works under general supervision, receiving general instructions: plans and executes own work; completes projects within the expected parameters and time frame

• Recommends new or creative approaches for product development, quality management systems, and laboratories

• May supervise scientists and/or laboratory technicians to complete assigned project work

• Ability to adopt a customer-support mindset (clear, professional, and positive communication)

Required Skill Set:

• Technical expertise in methodologies and instrumentation utilized in the development of assays, reagents, and/or next generation sequencing systems.

• Knowledge of quality and regulatory standards utilized in the development of new IVD products.

• Excellent writing and editing skills.

• Ability to articulate technical topics to a non-technical individual

• Excellent presentation and communication skills, meeting preparedness

• Ability to work independently, as well as on a team

• Organizational skills to prioritize tasks and make decisions in an environment with a large amount of information and rapid change.  Ability to contribute to multiple projects/demands simultaneously

• Applies advanced technical knowledge to multi-disciplinary projects

• Ability to apply a holistic systems thinking approach

Formal Training/Education:

• Bachelor’s degree in Biological/Life Sciences, Chemistry, System Engineering, Design Quality, or an equivalent combination of education and work experience is required.  Advanced degree preferred.

• Formal training in IVD or medical device related quality, regulatory, system engineering and/or product development processes preferred

Required Experience:

• Minimum of 5 years relevant industry experience (e.g. IVD product development, quality, lab management).

• Minimum of 3 years experience working in a wet-laboratory environment.

Desired Experience:

• Experience in next generation sequencing technology, assay development, reagent development.

• Experience in developing processes and/or product development documentation deliverables related to quality management systems, Good Laboratory Practices, Good Documentation Practices, ISO 13485:2016, IVD-R, and Quality System Regulations, CLSI guidelines, and/or CLIA.

• Experience in Agile development, Scrum, and/or Kanban technical project management methods.