Senior Product Development Scientist
- Employer
- Clear Labs
- Location
- San Carlos, CA
- Closing date
- Oct 30, 2021
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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:
Requirements
Benefits
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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