Senior Product Development Scientist

Employer
Clear Labs
Location
San Carlos, CA
Closing date
Oct 20, 2021

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Sector
Science
Job Description
We are seeking an experienced and driven Senior Product commercialization Scientist to join our dynamic and fast-paced start-up. The successful candidate will be involved in late-stage development and commercialization of RUO and IVD assays and platforms related to infectious disease diagnostics and surveillance and other applications related to human and animal health.

Tasks & Responsibilities:
  • Plan & perform all the late stage product development activities like assay characterization & optimization, improving robustness, guardbanding, etc., by collaborating with all the R&D teams
  • Prepare detailed development reports for the assays as part of the design history file
  • Develop SOP & protocols for making custom reagents to be made in-house
  • Develop QC methods for critical reagents and facilitate transfer to manufacturing
  • Perform risk assessment, prepare dFMEA and pFMEA for the assay and workflow respectively and brainstorm mitigation strategies
  • Write Verification & Validation test plan in collaboration with assay, automation, bioinformatics, software and quality teams
  • Perform Verification & Validation experiments and present the results to the product core team
  • Collaborate with the reagent manufacturing team to perform shelf life & storage stability studies for critical reagents and develop kitting procedures accordingly
  • Be a key contributor to the product design by participating in design reviews and providing critical inputs
  • Demonstrate the feasibility of new methods, and efficiently move products through pipeline up to and including transfer to manufacturing and scale-up
  • Contribute to both internal and customer-related troubleshooting efforts
  • Conduct clear and concise communication with colleagues (cross-functional) and supervisors through oral updates, written reports, and technical meetings
  • Be both a strong individual contributor as well as a collaborative team member
  • Train and mentor junior scientists

Requirements
  • MS/PhD or equivalent in molecular biology, genetics, genomics, microbiology, biochemistry or related fields.
  • 5 or more years of experience in the commercialization of automated diagnostic assays
  • Deep technical knowledge in genomic methodologies (RT-PCR, multiplex PCR, nucleic acid quantitation) and a comprehensive knowledge of NGS sample preparation, library preparation and sequencing methods are required
  • Be hands-on in the lab and be able to work in a team environment and independently
  • Demonstrated ability to plan hypothesis-driven experiments, analyze data sets, interpret results, document reports and present results
  • Experience with design, execution, and analysis of DOEs
  • Experience with bioinformatic analysis of NGS datasets using R, Python, etc. will be a plus
  • Adept at troubleshooting and root cause analysis
  • Excellent oral and written interdisciplinary communication skills
  • Be highly committed, operate well under pressure and deliver results in a fast-paced, technically challenging environment
  • Team player with strong interpersonal skills
  • Can do attitude, resourcefulness to adapt and high energy are desirable attributes

Benefits
  • Full medical, dental, vision insurance
  • Onsite organic snacks
  • Lunch onsite 5 days a week
  • Unlimited Flexible Time Off
  • Life Insurance (Basic, Voluntary & AD&D)
  • Family Leave (Maternity, Paternity)
  • Short Term & Long Term Disability
  • Training & Development
  • Stock Option Plan

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