Senior Scientist, Product Development

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)