Job Description*This job is located on the Peninsula*BioPhase Solutions
specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Senior Scientist
that values a collaborative, high performing work environment to contribute to the mission of a growing, widely recognized Bay Area molecular diagnostics company. If this sounds like you, please consider the following opportunity.Scientist III / Senior Scientist, Product Research
*leveling based on amount of relevant experience as described in the requirements section, and as assessed throughout the interview process.
SUMMARYContribute to the Product Development of novel diagnostic products. This position will significantly contribute to study design and documentation and conduct bench studies while working to strict design control requirements.
- Fluent at developing fully interpretable and actionable experimental designs. Excellent data interpretation skills.
- Independently develop SOPs, experimental protocols, and prepare reports that become part of the Design History File and meet FDA level requirements.
- Proven success leading projects collaboratively as both an intellectual leader and direct contributor at the lab bench, with delivery of results in a timely fashion, by partnering with colleagues and across company disciplines.
- Demonstrate effective mentoring of laboratory tasks performed in the hands of others. Contribute collaboratively on the laboratory troubleshooting needs within and outside of R&D.
- Hands-on knowledge of the basic biological principles governing molecular biology, genetics, and biochemistry underlying laboratory assays and clinically relevant information.
- Fluency with clinical sample preparation, assay and quality control under high-throughput production conditions at the highest standards of traceability and referential integrity.
- Goal-oriented and timeline-driven in support of company objectives. Demonstrated ability to thrive in a fast-moving environment and acknowledge that product timeliness is essential to commercial success.
- Interact seamlessly with multi-disciplinary teams such as clinical, bioinformatics / data analysis, regulatory and marketing groups.
- Experience with various high-throughput molecular biology platforms including next-generation sequencing, microarrays or other hybridization-based detection systems, and qPCR.
- Ph.D. in biology, molecular biology, genetics or a related field. Domain expertise in prostate, bladder, lung, or renal cancer is desirable.
- Minimum 5 years (Scientist III) to 8 years (Sr. Scientist) of postgraduate laboratory bench experience, with 2-3 years of postdoctoral experience and 2-5 years of industry experience preferred. Relevant industry experience under Design Control and associated Quality Systems in regulated product development (LDT / diagnostics, PMA or 510(k) device, CE-mark, IVD) strongly preferred.
- Strong background in molecular genomic technologies (both RNA and DNA), including experience in next-generation sequencing, microarray or other high-throughput platforms.
- Genomic data analysis and interpretation/visualization skills are desirable.
- Demonstrates tact and diplomacy in working with external and internal collaborators
- Ability to work independently and to exercise good scientific judgement
- Excellent teamwork and collaboration skills
- Excellent written and oral communication skills
- Willingness to speak up for their interpretations of data or strategy, to ask questions, or to advocate.