| Job Description | The Associate Director of Product Development is responsible for directing projects to develop and commercialize molecular diagnostic assay products on the next generation sample to answer platform utilizing the Company's eSensor® Detection technology. In this role, s/he will also have assay development functional responsibility to build and develop core competency in scientific excellence in molecular diagnostics, design control, clinical study and submission support. The Associate Director of Programs & Assay Development will report to the Head of R&D and lead a team of employees ranging from scientists, research associates and/or assay development managers in Assay Development. This position will be located at the company's headquarters, in beautiful Carlsbad, CA (north county San Diego).
Accountabilities:
••Directs and manages multiple programs to develop assays for future eSensor® products. Drives cross-functional teams to deliver new products to specifications, on time and on budget.
•Leads a team of scientists and research associates in technology assessments and development for automation of DNA/RNA extraction, PCR and assay integration of existing assays onto new sample to answer platforms.
•Effectively utilizes external resources to meet project objectives.
•Maintains organizational focus and expertise on innovation best practices and scientific excellence.
•Works closely with the Clinical, Regulatory and Quality departments for successful clinical studies, regulatory submissions and design control processes.
•Cooperates with manufacturing and supply chain to facilitate effective transfer of assays to manufacturing.
•Aligns with Marketing and Sales on new product requirements and commercialization activities.
•Builds and provides leadership for an effective team in a high growth environment including hiring, on-boarding, developing, goal setting, performance improvement and disciplinary actions.
•Provides an open environment and promotes teamwork across the organization.
Key Qualifications & Experience 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.
•Hands on with a strong sense of urgency, discipline, commitment and organization with regard to commercializing new products and achieving Company objectives.
•Proven and effective interpersonal communication skills with a demonstrated ability to interact with customers and sales team in a positive, friendly, and professional manner.
•Excellent presentation skills and writing communication.
•Adept at influencing, gaining consensus, and capable of overcoming resistance by presenting a powerful case for implementing new initiatives or ideas.
•Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.
•Strong team player and team leader with excellent interpersonal skills.
•Ability to thrive in a challenging and fast paced environment.
•Results oriented, entrepreneurial and self-motivating. |
| | Company | | GenMark Dx | Job Code | | State or Province | | California | | |
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