Molecular Diagnostics Development Leader
Overview of the position:
The Molecular Diagnostic Development Leader acts as the subject matter expert and process leader in the design, development and validation of molecular-based tests in a regulated, clinical environment. The position works collaboratively with various stakeholders and other functional leaders to ensure successful development, validation and technology transfer of assays to the Clinical Services Testing Laboratory and cGMP Production Facility.
This position will oversee individual project leaders to ensure that the execution and performance of scientific activities meet and follow established procedures within the company Quality Management System (ISO 13485:2016 and FDA 21 CFR Part 820) and per compliance with Federal, State and client defined requirements. The position ensures compliance with the company’s design control processes required for IVD medical device development and commercialization..
The role actively supports corporate growth and revenue initiatives by directly collaborating with Scientific Affairs and Business Development and participates in client interactions as needed. The position requires the ability to professionally communicate with clients and accurately convey appropriate design requirements that meet analytical and clinical performance needs.
This position works closely with senior management and provides leadership and cross-functional support to develop product and service strategies, implement corporate objectives and realize management directives. The Molecular Diagnostic Development Leader must be able to think strategically and creatively while contributing to multiple projects simultaneously and work productively in a collaborative, multi-disciplinary and diverse team setting.
This position may require flexible scheduling in order to meet departmental needs.
- Doctoral degree (Ph.D.) (or equivalent) in Molecular Biology or similar field
- More than 10 years of experience related to o oncology based laboratory developed tests and IVD molecular assay development
- At least 3 + years’ experience in the technology transfer for molecular based IVD’s
Essential duties and responsibilities:
The Molecular Diagnostic Development Leader is responsible for the following essential duties and responsibilities:
- Provides technical and process oversight of the molecular assay development laboratory and assigned personnel based in Portland, OR
- Oversees the design, development and validation of molecular assays according to product requirements
- Authors or reviews assay development plans, project reports, SOPs and other assay-related documentation as needed to ensure accuracy, clarity, compliance and completeness
- Independently executes experiments according to approved project development or assay validation plans, budgets and timelines as needed
- Provides critical review of assay development and performance data
- Analyzes and provides recommendations to the Pathologist/Laboratory Director in interpreting unusual or challenging results
- Works with Scientific Affairs and Business Development as needed to support and secure new business to help meet corporate objectives, including drafting and reviewing of proposals and associated budgets.
- Provides input on costing and timelines for test development, validation and tech transfer
If you are interested in joining our team and would like to be considered for a future job opening, please email your resume to: firstname.lastname@example.org