Scientist, Application, Translational Research and Product Design - SII
Full Time
Baltimore, MD 21205
Posted
Job description
Overview:
...to improve the lives of others.
...to build a promising future. Responsibilities:
The Scientist, Translational Research and Product Design Application, will work with the Associate Director to develop the department to function as an internal bridge between R&D and Commercial Operations (ComOps), an external link between Sysmex’s scientific and technical capabilities and the customer. S/he will translate customer requests and market needs into genomic product design requirements and will recommend the most effective existing or novel strategies and technologies for development of LDT products to fulfill various requests. S/he will also work downstream of product design to ensure all technical specifications meet the design requirements and will support generation of performance data for scientific marketing, regulatory submissions, and to fulfill customer and investigator needs. As needed, additional responsibilities may include technology support for customers, Sales & Marketing, and Medical/ Scientific Affairs, as well as upstream technology evaluation for broadening of Sysmex Inostics’ molecular diagnostic portfolio.
Essential Duties and Responsibilities:
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds;
Individual Education & Training Required for Position: Training required for this position is defined and governed in accordance to COP-0013 Associate Training and will be assigned in the LMS. Qualifications:
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Find a Better Way...
...to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
...to build a promising future.
We currently have a great opportunity available for a Scientist, Application, Translational Research and Product Design (REMOTE). The Scientist, Application’s primary responsibility is to ensure Sysmex Inostics’ liquid biopsy next generation sequencing platforms are effectively transformed into unique genomic diagnostic products that can be successfully commercialized to meet the needs of biopharma and academic customers. Products will begin life based on the needs of biopharma customers and highly differentiated market opportunities as Laboratory Developed Tests (LDT) offered via centralized testing at Sysmex Inostics Inc.’s CLIA laboratory (Baltimore, MD) and/or Sysmex Inostics GmbH’s GCP laboratory (Hamburg, Germany). LDTs will test the market and, where appropriate, may advance towards a higher regulatory status and/or transformation into a distributable kit for increased access to testing.
The Scientist, Translational Research and Product Design Application, will work with the Associate Director to develop the department to function as an internal bridge between R&D and Commercial Operations (ComOps), an external link between Sysmex’s scientific and technical capabilities and the customer. S/he will translate customer requests and market needs into genomic product design requirements and will recommend the most effective existing or novel strategies and technologies for development of LDT products to fulfill various requests. S/he will also work downstream of product design to ensure all technical specifications meet the design requirements and will support generation of performance data for scientific marketing, regulatory submissions, and to fulfill customer and investigator needs. As needed, additional responsibilities may include technology support for customers, Sales & Marketing, and Medical/ Scientific Affairs, as well as upstream technology evaluation for broadening of Sysmex Inostics’ molecular diagnostic portfolio.
Essential Duties and Responsibilities:
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Define and bring to market new products and/or workflows for Sysmex Inostics’ genomic diagnostic products based on customer and market needs. Robust understanding of product development process, including design requirements such as clinical intended use(s), selection of genomic targets, and analytical performance characteristics.
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Own product design requirements for individual customer requests as well as development of a lean customization process to ensure diverse requests can be handled quickly and efficiently
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Own lifecycle management of products in portfolio, and define product roadmaps, product requirements, engage and guide our R&D teams to deliver high impact new products.
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Build strong relationships and collaborations with internal groups such as R&D, Commercial, Marketing, Regulation, Production and other key individuals and teams. Become an expert on the technical details of Sysmex Inostics products and use this knowledge to support key groups throughout the product lifecycle.
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Ensure performance and verification/validation data as well as comprehensive technical specifications meet product design requirements. Identify gaps and recommend additional studies for generation of data needed to maximize the chances of commercial success.
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As Sysmex Inostics’ clinical oncology products continue to evolve from RUO, to LDT, and IVD requirements recommend the best course of design, development, and validation practices, ideally based on previous experiences dealing with broader next generation sequencing-based assays.
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Work with Associate Director of Translational Research and Product Design for continuous development of a culture of Clinical Product Development within Sysmex Inostics. Evaluate technology capabilities and product design against customer & market needs to ensure alignment. Where gaps exist, recommend new technologies and/or updates to product design.
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Use previous experiences in product development of Next Generation Sequencing to help promote continuous growth of Sysmex Inostics into a world-class provider of genomic diagnostic solutions for oncology. Product development and launch experience is preferred.
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Leverage the voice of customer and market insights to create a long-term strategic product roadmap.
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Other duties as assigned.
Percentage of Travel: 10%
Physical Risk. Regular exposure to risk that may require alertness, but with minimal precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds;
prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Individual Education & Training Required for Position: Training required for this position is defined and governed in accordance to COP-0013 Associate Training and will be assigned in the LMS.
- Bachelor’s degree in relevant scientific field and at least 5 years’ experience in genomic diagnostic product development required. Core understanding of molecular biology and Next Generation Sequencing.
- Extensive NGS product development and implementation experience for a leading provider of genetic/ genomic testing.
- Highly adept technical proficiency for next generation sequencing technologies, rooted in hands-on laboratory experience and having developed into a comprehensive understanding of the technical requirements for a commercially successful clinical product.
- Highly organized, analytical, creative, and strategic thinker capable of generating creative concepts and evolving them into action plans to support strategic goals and drive results.
- Exhibit strong analytical skills with the ability to understand and resolve complex issues.
- Excellent communication skills, verbal and written (PowerPoint presentation and oral presentation skills are required).
- Advanced computer skills required.
- Experience leading cross-functional teams.
- Excellent written and verbal communication skills.
- Highly organized and detail oriented.
Sysmex’s COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual’s ability to provide proof of current vaccination status. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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