Associate Director, Assay Development - San Diego, CA | Biospace
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Associate Director, Assay Development

Biological Dynamics

Location:
San Diego, CA
Posted Date:
6/19/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Assay Development, Biochemistry, Cell Culture, Oncology,

Job Description

Based in San Diego, CA, Biological Dynamics, Inc. (BioDyn) is a privately held molecular diagnostics company and a pioneer in the field of Alternating Current Electrokinetics (ACE)-based diagnostics.  At BioDyn, we are developing novel diagnostic solutions to screen, diagnose and manage high burden conditions, such as cancer. Our diverse team shares a passion for improving patient care, a focus on cutting-edge technology, and a deep commitment to innovation, which shapes the future of our company and drives our innovative culture. To learn more about BioDyn, please visit our website, www.BiologicalDynamics.com, or feel free to view a TEDx Talk given by BioDyn’s Co-founder and CEO, Dr. Raj Krishnan, at https://www.youtube.com/watch?v=wMsOYqJ4ShA.

Of immediate need to BioDyn is a full-time Associate Director, Assay Development to help lead the design, development and validation of assays on our proprietary technology platform.    This position will also have responsibility for the refinement, implementation, and use of industry-standard molecular and biochemical assays, with a focus on quantitative PCR.  We expect that the ideal candidate will have had proven experience in developing assays, working with novel technology platforms, and interfacing across disciplines, including biochemistry, molecular biology, engineering, and software development.  In addition, the ideal candidate will be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.

Key Responsibilities:

•   Plans, executes, and analyzes experiments for assay development activities throughout feasibility, design and development stages of the product development cycle;

•   Understands the engineering of novel instrumentation and its implications for assay development;

•   Investigates the application of a wide variety of scientific principles and concepts to potential inventions and development activities;

•   Uses various statistical data analysis methodologies for data analysis;

•   Provides direction and guidance to other members of the Assay Development group;

•   Partners effectively with Engineering, Quality, Marketing, and all other groups in support of Product Development objectives;

•   Contributes to Design Reviews, Stage Gate meetings, and other processes required to advance through Design Control in support of IVD product development;

•   Identifies opportunities for process improvements and contributes to their implementation;

•   Works as a productive member of a team while showing the appropriate level of autonomy in designing, performing and analyzing experiments;

•   Communicates, presents, and writes documents in a variety of formats and for different audiences, including internal and external meetings, patents and publications;

•   Understands and applies risk management concepts in areas of direct responsibility; and

•   Other duties as assigned.

Requirements

•   Ph.D. in Biochemistry, Molecular Biology, Bioengineering or a related field, with at least 4 to 6 years of postdoctoral experience in industry.  Candidates with a Master’s degree in a scientific discipline and 10+ years of experience, including highly relevant expertise in industry, may be considered;

•   Broad expertise in the development of assays, preferably of a diverse nature;

•   Experience in biochemistry, preferably with applications to molecular biology/nucleic acid analysis.  Direct experience in quantitative PCR assays and nucleic acid detection techniques preferred.  Expertise in immunoassay development useful;

•   Knowledge of a variety of detection technologies, especially fluorescence-based assays and their use for nucleic acid quantification;

•   Experience in sample preparation and in the processing of clinical specimens for the recovery of nucleic acids preferred;

•   Experience in the commercialization of molecular diagnostic products (US FDA 510k/PMA and CE mark) preferred;

•   Knowledge of cell biology and experience in cell culture is a plus;

•   Experience leading, guiding and mentoring junior scientific staff; direct, formal supervision in a company environment preferred;

•   Excellent verbal and written communication skills;

•   Awareness and application of scientific literature and industry standards and regulations such as ISO, CLIA, etc. and how they relate to internal policies and procedures; and

•   Experience with oncology IVD assays desired.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the individual may be required to sit; use hands to touch, handle, or feel and reach with hands and arms. As well, s/he may occasionally be required to stand and/or move about the office. Specific vision abilities may be required by this job including close vision and ability to adjust focus.

The successful candidate will join a dynamic, innovative team focused on developing cutting edge technologies in a fast-paced, collaborative environment. We offer a positive, diverse and exciting work environment with competitive compensation and benefits.  Biological Dynamics is an equal opportunity employer. To apply please submit your cover letter and resume.