| South San Francisco, CA
(Some remote work options)
The Robinson Group is partnering with a global, Fortune 100 company at the forefront of the life sciences industry.
They are looking for a Staff Scientist who wants to be a major driver in impacting patient’s lives.
Very competitive salary, bonus and benefits with great work/life balance.
Employee-centric company open to relocation and visa transfer.
This is an opportunity for a highly motivated IVD scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine.
The ideal candidate will be a strong team player who is passionate about delivering high quality simple, effective, customer-focused products.
The successful candidate will incorporate IVD and molecular biology experience to develop
robust, innovative diagnostics.
- This is a hands-on lab position, including mentorship and project lead responsibilities
- Collaborates with cross functional core teams
- Plans and executes IVD development experiments, from proof of concept to validation, regulatory submission and launch
- Actively participates as a member of cross-functional product development teams
- Leads data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods
- Ensures products are adequately developed to enable smooth Design Transfer
- Documentation under design control to ensure quality product development
- PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering with at least 5 years of biotech experience
- Developed and launched commercial qPCR Assays
- Demonstrated teamwork under tight timelines
- Strong experience in IVD product development, following ISO 13485, 21 CFR Part 820, Risk
- Analysis ISO 14971
- Have submitted 510k/PMA and / or List A CE-IVDD (or List D IVDR)
- Design Control & Change control, and experience writing design quality records
- Expertise in Process Capability / Six Sigma
- Experience participating in audits
- Demonstrates passion for problem solving and outside-the-box thinking
- Demonstrates passion for mentoring and team development
- Strong communication and presentation skills are essential
- Must be highly collaborative and always willing to help others
- Self-motivated, independent, proactive, organized, diligent, and very nimble
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