R&D Manager, In Vitro Diagnostic (IVD) Molecular Biology

Carlsbad, CA
October 03 2017
Position Type
Full Time
Job Description

Develop and validate an automated next generation IVD sequencing system based on Ion Torrent technology with the objective of meeting FDA regulatory requirements for commercialization.
Apply management and laboratory skills and experience working in the regulatory environment for IVD product development, Verification and Validation, manufacturing and transfer, and commercialization.
The ability to communicate with stakeholders, manage projects, meticulously document and communicate results to diverse audiences is important aspects of this role.
Design experimental plans, write experiment protocols, lead study execution, analyze experimental data, and write technical reports, quantitative analyses, and product summaries.
Troubleshoot and solve problems in the design and execution of development projects.
Investigate, create and incorporate new methods and technologies to improve effectiveness of development workflows.
Present data at scientific conferences and prepare relevant publications.


Ph.D in Molecular Biology, Biochemistry, Chemistry or related field of study plus 2 years of commercial assay development setting or related experience.

Must have experience or knowledge of:

IVD assay development including: reagent development and optimization, assay protocol optimization, verification study development and report production, proven experience with IVD design control regulations, requirement setting, specification development;
Development of quality control methods and specification setting;
IVD software testing and bug finding;
Experience with direct reports and with managing a technical team;
Nucleic acid analysis including PCR amplification and purification, NGS sequencing, nucleic acid extraction from clinical samples; and
Experience with GLP and GMP quality management expectations and compliance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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