Scientist 1 - Senior Scientist

2 months ago

Santa Ana, United States BiotechnologyJobs, Inc Full time

About the Company:

This client is an early-stage, California-based company focused on developing and manufacturing small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver secure lab quality results.


About the Role:

We are seeking a highly motivated scientist to join our dynamic biotech industry team. The Scientist I will be responsible for initiating, directing, and executing scientific development strategies to facilitate the design and development of novel, point-of-care molecular diagnostic products. They will make major contributions to accessing the feasibility of scientific principles and concepts to potential inventions and products. They will interface with various departments to contribute to the development and completion of company goals and objectives in creative and effective ways. The candidate must be detail oriented to plan, execute, and analyze molecular biology experiments including PCR, RT-PCR, and nucleic acid extraction.


Responsibilities:

  • Be a collaborative part of a multidisciplinary group of scientists and engineers to drive the development of point-of-care diagnostic products from concept and design, through system and assay integration, verification and validation activities, and design transfer to manufacturing.
  • Rapidly prototype new ideas from the research and development groups and integrate them onto a microfluidic platform for rapid iteration and development.
  • Oversee, plan, and execute experiments to study design feasibility, identify & characterize critical design parameters, and optimize microfluidic disc assay and device performance.
  • Ability to work in a fast-paced environment with deadline-driven workflows.
  • Work closely with engineering, software, quality, and manufacturing staff to ensure reliable integration, scale-up, and transition to production of new diagnostic tests on automated microfluidic platforms.
  • Responsible for authoring various manufacturing and raw material specifications and QC documents required for transfer of products to manufacturing, and other documents and reports required during product development.
  • Uses professional concepts and relationships to contribute to the development and completion of company goals and objectives in creative and effective ways.
  • Perform root cause analysis for complex technical issues and offer design modifications pertaining to assay and system performance.


Qualifications:

Minimum Bachelor's degree in the field(s) of molecular biology, biochemistry, clinical chemistry, bioengineering, chemistry, or equivalent.

Current California resident.


Required Skills:

  • Minimum of 5 years of industry experience in a molecular biology atmosphere involving RT-PCR assays with a good track record in bringing assays to market (CE mark, FDA or CLIA).
  • Background in analytical methodologies and design of experiments (Minitab or JMP) and statistical analysis.
  • Familiarity with CE and FDA regulatory requirements for IVD products and product development under design control.
  • Motivated team player with attention to detail and ability to prioritize work in a fast-paced environment.
  • Strong English written and oral communication skills.
  • Experience leading teams, training, and mentoring staff.


Preferred Skills:

  • Previous experience with 6 target multiplex, UTI, STI, or Strep.
  • Experienced in interpreting and analyzing large scale experimental data.
  • Cooperative team player with a positive attitude and solid work ethic.
  • Experience with training and overseeing the work of Research Associates.
  • Sets specific goals and objectives to complete tasks on-time in an organized manner.
  • Effectively communicates in both written and oral presentations on data generated.
  • Enjoys taking on new challenges and finding creative ways to solve a problem.


Pay range and compensation package:

$80-105K for Scientist 1. Level/compensation is flexible up to Senior Scientist.


Equal Opportunity Statement:

We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.

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