Staff Scientist - Molecular IVD Product Development

Organization: 
GenMark Diagnostics
Job Location: 
Carlsbad, CA
Job Description: 

Lead and reach out throughout the organization to engage others, align, and deliver results in product development in GenMark's R&D team. Take on an active lead role and be responsible for developing numerous IVD products through FDA and CE mark approvals to commercialization.

Plan, direct and analyze the results from scientific experiments leading to the design, development and transfer to manufacturing of DNA array-based products for the detection, identification and quantification of nucleic acids and the diagnosis of diseases. Develop technical solutions to product design and performance issues.

• Take leadership, build trust, and serve as a key technical or project lead on one or multiple products while managing the development and commercialization of a new sample-to-answer platform and associated assay menu. Manage project plans according to timelines and deliverables, provide project cross functional review of project status.
• Design, perform and analyze experiments to design and characterize the performance of products relative to product performance and customer requirements.
• Align with Regulatory and Clinical departments to conduct and document the studies necessary for Class II and III IVD, i.e., 510(k) and PMA, worldwide regulatory submissions.
• Collaborate with Assay Development, Quality, Operations and other functions to demonstrate assay feasibility and product concepts; conduct assay development optimization on the automated platform; assay and system verification & validation; development of manufacturing processes, procedures, test methods and specifications; as well as transfer to sustaining organizations.
• Identify, invent, develop and implement effective solutions to technical issues based on scientific knowledge, evaluation of the scientific literature, and laboratory research.
• Perform internal verification and validation of product performance.
• Design, characterize and validate test methods.
• Design and perform stability testing protocols.

Requirements: 

• B.S., M.S., or Ph.D.in Biochemistry, Microbiology, Molecular Biology or a related field.
• Minimum of 7 years in experience in Molecular Diagnostics, Diagnostics, IVD Product Development, or related field in an industrial setting.
• In depth knowledge of product development process – demonstrated success in leading multiple product development projects from feasibility to launch in GMP environment.
• Demonstrated expertise in Design Control methodologies
• Experience as a core team leader or technical lead on product development project. Demonstrated project management experience leveraging classic tools such as program timelines, phase gate reviews, dashboards, etc.
• Highly Desired: Experience in IVD regulated environment writing protocols for 510(k), PMA submissions to the FDA
• In-depth knowledge of molecular biology, including searching and analysis of genetic databases, principles of nucleic acid hybridization, probe and primer design, molecular cloning and enzymatic amplification of specific gene sequences.
• 5+ years experience in development of multiplex PCR and/or reverse-transcriptase-PCR assays. Experience with asymmetric PCR systems desired.
• Experience with product design and development of nucleic acid-based assays for disease detection and diagnosis of disease or development of pharmaceutical products in a regulated environment is highly desirable.
• Organizational, planning and detail follow-up skills required.
• Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
• Ability to handle and resolve conflicts and work under stressful conditions
• Demonstrated ability to be flexible and resourceful. Excellent communication and diplomacy skills required.
• Knowledge of safety precautions required for working with blood borne pathogens at Biosafety Level 1 and 2

Travel:
Up to 10% intermittent travel may be required

Contact Information: 

To Apply:

Please email your resume to careers@genmarkdx.com and include the Job Title in the subject line of your email.

AN EQUAL OPPORTUNITY EMPLOYER
All employment decisions are made without regard to race, color, religion, sex, sexual orientation, national origin, age, creed, ancestry, marital status, non-job-related handicap or disability, veteran status, or any other legally protected status.

About Our Organization: 

GenMark Dx’s mission is to become the market leader in providing high value, simple to perform, clinically relevant multiplexed molecular tests to aid in the diagnosis of disease and the selection and dosing of therapies. GenMark Dx’s proprietary eSensor® technology is based on the principles of competitive DNA hybridization and electrochemical detection. Our eSensor® technology is highly specific for the target biomarker and is not based on fluorescent or optical detection. As a result, our diagnostic tests are less prone to sample contamination risk and do not require many of the time-consuming washing and preparation steps required by competing multiplexing technologies.