Senior Scientist, Product Development

Location
San Diego, California
Posted
Jul 31, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Summary of Major Responsibilities

The Senior Scientist – Product Development is responsible for independently driving research, assay development, product development activities. He or she designs and conducts complex, goal-oriented experiments, independently makes detailed observations, analyzes data, interprets results, and communicates results as internal presentations to cross-functional teams, externally-facing slides/posters, and design control documentation. He or she works cross-functionally with members of R&D, Operations, Quality, Regulatory, Clinical, and Commercial departments to achieve project goals.  The Senior Scientist – Product Development provides technical leadership, helps manage activities of more junior members of the team, and stays up-to-date with relevant studies, literature, and market developments.

Essential Duties and Responsibilities

  • Contribute to the company’s portfolio of ideas and products that have the potential to provide solutions to unmet needs in the market place
  • Responsible for moving new ideas/products through the research and development phases
  • Review current products to identify improvements and determine if they can be used differently to expand the potential customer base
  • Responsible for identifying patentable inventions, acting as principal investigator in conducting experiments and assisting with pre-submissions for patents
  • Design plans and studies to achieve technical and product development goals
  • Contribute technical knowledge to improve laboratory capabilities in research and development efforts
  • Provide effective design, execution, and analysis of complex experiments to achieve project milestones
  • Research current scientific literature and contribute relevant information to a project, as well as investigating, creating, and developing new methods and technologies for project advancement
  • Serve as subject matter expert for relevant projects/products
  • Generate landscapes that summarize relevant market products and devices
  • Develop and validate assays as needed
  • Scientific trouble shooting and hands-on problem solving
  • Handle human and animal blood and other body fluids with confidence
  • Simultaneous management of ongoing experiments
  • Analyze and interpret complex data and solve complex problems through strategic, goal-oriented decision making and experimental design
  • Present clear project summaries in written and verbal formats to internal and external scientific and management teams
  • Work with other departments for transfer of products, processes, and knowledge
  • Adhere to applicable regulatory guidelines
  • Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance
  • Assist in hiring and directing the work of the Research Associates
  • Support and comply with the company’s Quality Management System policies and procedures
  • Ability to work a normal schedule of Monday through Friday during normal business hours
  • Regular and reliable attendance
  • Other related duties as required and/or assigned
  • Ability to apply advanced statistical knowledge
  • Ability to meet project goals and execute experiments
  • Ability to work independently to plan and execute experiments
  • Ability to apply strong organization and time management
  • Ability to demonstrate proficiency in writing detailed technical documents and standard operation procedures
  • Team player with excellent interpersonal skills
  • Ability to lift up to 10 pounds for approximately 10% of a typical working day
  • Ability to work in front of a computer screen and/or perform typing for approximately 50% of a typical working day
  • Ability to comply with any applicable personal protective equipment requirements
  • Ability to travel approximately 10% of working time

Qualifications

Minimum Qualifications

  • PhD in molecular biology, biochemistry or related field; OR Master's in molecular biology, biochemistry or related field and 2+ years of laboratory experience in lieu of Ph.D.
  • 8+ years of relevant experience
  • 5+ years of laboratory experience
  • 2+ years of experience leading a team
  • Knowledge of common laboratory techniques such as PCR, qPCR, ELISA, and cell culture
  • Familiarity with DNA, RNA, and protein-based techniques
  • Authorization to work in the United States without sponsorship
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and statistics software (JMP, R, or equivalent)

Preferred Qualifications

  • 3+ years of industry experience
  • Previous experience working with biological fluids such as blood, saliva, urine
  • Track record of innovations through patents and publications in high profile journals
  • Previous experience with sample and reagent preservation
  • Experience with IVD product development (CE, FDA)