As the Manager, Research & Development Laboratory, you will be responsible for managing laboratory personnel (e.g. Lab Associates, Scientists...) who are responsible for leadership and the execution of various laboratory activities. In addition, you will provide scientific and technical expertise within a cross-functional team to research and develop novel IVD products and services in the area of cancer biology. This position reports to the Director, Genomic Sciences within Research & Development.
You will participate, interact with and support various cross-functional teams and may act as a liaison between these teams and the Product & Services R&D group.
You will also participate in improving current commercial assays and developing future products through technical/scientific groups providing scientific and technologic support to Product Teams. Additionally, you will facilitate and may lead the execution of clinical and analytical lab studies.
RESPONSIBILITIES / DUTIES:
· Management of Lab Associates and Scientists who are involved in the development of IVD and LDT products
· Work with Human Resources staff to recruit, interview, select and hire new employees
· Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning
· Provide oversight and direction to the employees in Genomic Sciences in accordance with the organization's policies and procedures
· Lead and participate in efforts to support the development of IVD products under design control in conformance with ISO 13485. Partner with Product Sciences, Biostatistics, and
other functions in the development and use of appropriate test methods for the development and launch of new products.
· Create required documents such as standard operating procedures, protocols, and reports for studies required to develop and transfer assays into production.
· Provide scientific expertise in the areas of cancer biology, molecular genetics, and tissue- and non-tissue-based methods for evaluating tumor-associated biology.
· Maintain up-to-date knowledge in the above areas, and proactively propose and implement the application of new ideas and concepts in GHI programs
· Maybe a member of Development Subteam(s) or Working Group with the following accountabilities:
o Execute projects related to the product development plan, intellectual property, system design, readiness and transition from Development to Commercial Operations
o Participate in assay development from investigation through validation
· Collaborate closely with peers to address product-related biological and technology development issues and escalate project prioritization conflicts impacting resource availability.
· On teams, provide subject area expertise (biology, technology, process, genomics, etc.) directly or identify a subject matter expert within the R&D group to consult with the team
· Participate in research and development protocols for a wide range of studies, including feasibility, exploratory, clinical and analytical validation, and post-marketing studies, to be
executed within R&D under Design Control
· Provide scientific input for product and process improvements
· May participate in the authorship of abstracts and publications; may be responsible for some final reports
· May provide internal education about our products and technology to new and existing employees at the varied experience and technical knowledge levels
· Apply the best principles of design controls, CLIA and GCP to product development as appropriate
· Bachelor's degree in molecular biology, biochemistry, chemistry, or an associated relevant field with 10+ years of relevant industrial experience. Advanced degree preferred.
· Strong background in biochemistry and molecular biology methods with experience in assay development, nucleic acid isolation, purification, and quantitation, qPCR and next
generation sequencing assays
· IVD and Design Control experience highly desirable
· Knowledge of tissue-based and non-tissue-based methods for evaluating tumor-associated biology.
· Experience in cancer-focused research through publication or successfully development of products
· Scientific acumen leading to data-driven decisions
· Demonstrated strong oral, written and presentation-based communication and influencing skills
· Ability to execute dynamic projects and to prioritize and drive to results with a high emphasis on quality
· Able to integrate and apply feedback in a professional manner
· Strong team player