Sr. Scientist - Oncology R&D
This contract position is in the Oncology R&D group and is primarily focused on design control processes and product development documentation reviews in an FDA-QSR and ISO13485 compliant organization. The ideal candidate will have experience in product development, expert knowledge of scientific principles and concepts (such as molecular biomarkers and real time PCR). This candidate will assist in reviewing product design documents and conducting gap assessments and mitigations for novel assays. This candidate will be involved in all aspects of IVDR Compliance as related to assay development groups. In addition to technical qualifications, the ideal candidate will be highly goal-oriented, inquisitive, organized, and be able to thrive in an atmosphere of shifting demands and priorities. The candidate should possess excellent oral and written communication skills. The ability to solve complex problems and work in a cross-functional team-based environment is a requirement.
ESSENTIAL JOB RESPONSIBILITIES:
- Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations for technical documentation.
- Compile, prepare, review analytical performance portions of submissions under review.
- Provide technical review of documentation for product lifecycle management
- Respond promptly to core team members as needed. Track and manage technical documentation review timelines.
- Perform the majority of required duties with limited supervision. Provide weekly updates on status of projects.
- Interpret federal/state/international regulations as they apply to our technical documentation.
- Education or Experience (in years): Master's degree or equivalent in Cancer biology/Genetics/Molecular Biology or related sciences
- At least 7 years' R&D/Biostatistics and/or Regulatory experience in the IVD or medical device industry.
Knowledge and skills:
- Proficient in design control processes and procedures for IVD or medical devices
- Familiarity with FDA and international regulations for IVDs and/or medical devices
- Experience with in vitro diagnostic products and molecular technologies
- Technical writing skills and ability to review and summarize data into clearly written reports
- Working experience with statistics programs (JMP/Minitab) and familiarity with data analysis interpretation
- Strong inter-personal skills and an ability to comprehend and effectively communicate technical ideas and concepts to a diverse audience
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.