Job Description

Kelly® Science & Clinical is seeking a Senior Scientist, Global Market Protection for a 6-month contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Workplace: Onsite in Sunnyvale, CA.

Position Title: Senior Scientist, Global Market Protection

Position Type: 6-month contract

Pay rate: $50-60/ hour.

Company: Kelly® Science & Clinical

Overview and Responsibilities

The Senior Scientist, R&D MEMP (Market Expansion, Market Protection) is responsible for on-market product support in terms of post-market activities, to evaluate the performance of products against country-specific requirements and documentation for registration that drives significant impact to the organization. This position relies heavily on experiences gained in the design and development of molecular diagnostic products and provides hands-on experiences in molecular point-of-care tests in an FDA-QSR and ISO13485 compliant organization. This position is part of the R&D, Global Market Protection group and will be in Sunnyvale, CA, as a full-time, on-site, contract position.

Responsibilities

• Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations for technical documentation.
• Solve complex problems and work in a cross-functional team-based environment.
• Work collaboratively as part of a team while also working independently to produce data and meet challenging timelines and goals.
• Research, initiate, and procure clinical specimens and clinical matrices for R&D projects and execute end-to-end testing until final report generation.

Qualifications

• Proficiency in molecular lab techniques and ability to independently design and execute lab experiments with minimal guidance or direction.
• Design and execute statistically powered experiments with clinical specimens to verify assay performance.
• Interpret federal/state/international regulations as they apply to our technical documentation and participate in group meetings to share weekly progress on experimentation, documentation, and gap analysis.
• Demonstrate the ability to drive to the root cause of experimental problems as they arise, and troubleshoot with stringent hypothesis testing methods any software, hardware, assay design, or consumables issues.
• Ability to prepare high-quality technical documents on product design verification and validation for regulatory submissions.

Preferred:

• Trained and experienced in blood-borne pathogen-related lab safety and microbiology lab techniques.
• Experienced in Design of Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies.
• Experience with technical writing

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
• Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.

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