Sr. Scientist, Development & Transfer

Organization
Focus Diagnostics
Job Location
Cypress, CA
Benefits

Medical, Dental & Vision insurance,  short- and long-term disability insurance,  401(k) with company match, paid time off, performance-based merit and bonus programs, adoption assistance, wellness screenings, employee stock purchase plan, flexible spending, employee assistance plan. 

Job Description

Sr. Development & Transfer Scientist, Focus Diagnostics

 As part of the Quest Diagnostics family, Focus Diagnostics, Inc. is committed to providing proven and reliable products its customers have grown accustomed to throughout the years. Since its founding in 1978, Focus Diagnostics has grown its business from specialized laboratory testing to manufacturing its high-quality laboratory tests for hospitals and commercial laboratories worldwide. These manufactured tests are built in response to diagnostic testing trends identified and evaluated by Focus Diagnostics and used in Quest Diagnostics’ national laboratories. 

 The Sr. Development and Transfer Scientist will be the technical partner to the R&D teams responsible for successful design for manufacturability and manufacturing transfer of new products. Daily interaction and heavy engagement with R&D, Manufacturing Engineering, Manufacturing, Quality Engineering and other functions within Focus is expected of the scientist in this role. Uses professional concepts and relationships to contribute to the development and completion of company goals and objectives in creative and effective ways. Supports all applicable regulations including, but not limited to, FDA and ISO requirements.

 ESSENTIAL DUTIES & RESPONSIBILITIES

  • Actively participate in the development of new products as a representative of Product Transfer and Operations to ensure compatibility with current and future manufacturing processes and capabilities.
  • Partner with the R&D team to assess manufacturability throughout the life cycle of new products.
  • Conduct design for manufacturability testing and review meetings routinely.
  • As appropriate, serve as a technical liaison for other departments with regards to new product introduction activities, including, but not limited to, bill of materials, reference material, reagent formulation, and product or consumables testing.
  • Lead, coordinate, or participate in operations-related activities required for the successful transfer of new products to routine production including production scale-up, process development/optimization and technology transfer.
  • Assist manufacturing teams with process validation and test method validation studies.
  • Develop production documentation including procedures, worksheets, and bills of materials.
  • Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies.

 May direct an individual technician or a group of scientists and technicians. Works with other departments through matrix reporting to ensure development projects are effectively managed during the product development process.

Requirements

Requires a Ph.D. in a scientific discipline or equivalent with a minimum of 7 years experience in a manufacturing operations or research and development environment in medical devices, biotech, and/or pharmaceutical industries.  Non-doctoral level candidates may be considered, but they must demonstrate the ability to work as an independent investigator, have the ability to direct others, and at least 12 years of experience. Prior experience in developing in vitro diagnostic products through the design control process and experience with QSR required.  Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. Ability to work effectively with cross-functional core teams required. Detail oriented and ability to multi-task.

How to Apply

 Candidates are encouraged to visit our career site and apply online at www.QuestDiagnostics.com/careers, Job ID#3745334.    Or, you may forward your CV to [email protected].

Quest Diagnostics is an Equal Opportunity Employer. 

About Our Organization

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services
that patients and doctors need to make better healthcare decisions. We offer the broadest access
to diagnostic testing services through our network of laboratories and patient service centers,
and provide interpretive consultation through our extensive medical and scientific staff. Quest
Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare
information technology solutions that help improve patient care.

New study finds bias against female lecturers among student course evaluations, the Economist reports.

A research duo finds that science and technology graduate students who turn away from academic careers do so because of changes in their own interests.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.