As part of our company’s commitment to developing and delivering to the market a suite of high-performance products, we are growing the Assay Development team. One of our key open positions is for a Scientist I, Protein Biochemistry. The individual in this hands-on role will be responsible for assays, experiments, and studies that support the development of the company’s protein detection-based products. In addition, the individual will be involved in the design of highly robust assays and will perform analytical studies that support the registration of IVD products. Good interactions across disciplines, particularly with engineers, chemists, and molecular biologists, are critical in this role.
Responsibilities and Duties:
Determines approaches for assay development, in the context of the company’s product development needs and in close collaboration with other key personnel in product development and engineering;
Independently designs, performs, and analyzes experiments for assay development activities throughout feasibility, design, and development stages of the product development cycle;
Designs and, where needed, re-designs assay conditions, buffer compositions, experimental parameters, and any other factors required for assay robustness;
Identifies and provides creative and novel alternative approaches to meeting the challenges intrinsic to the development of the company’s products; Contributes to the identification, verification, and implementation of new assays and assay formats;
Partners effectively with other members of the Assay Development team as well as Engineering, Quality, Marketing, and all other groups in support of Product Development objectives;
Contributes on an as-needed basis to Design Reviews, Stage Gate meetings, and other processes required to advance through Design Control in support of IVD product development;
Effectively communicates experimental findings in written format and in internal company meetings and;
Other duties as assigned
Ph.D. in Biochemistry or a closely related field, with postdoctoral experience highly preferred. Candidates with a master’s degree and 3+ years of experience or a bachelor’s degree with 6+ years of experience may be considered, especially if the candidate’s background includes relevant industry experience;
Expertise in protein assay development, with a strong preference for biochemical assays; immunoassay experience also useful and relevant;
Experience in applying biochemical knowledge and approaches to develop and optimize protein-based assays preferred;
Experience in the development of diagnostic products (US FDA 510k/PMA and CE mark) preferred;
Knowledge of a variety of detection technologies, especially fluorescence-based assays;
Well versed in the use of standard statistical packages (i.e. JMP) for data analysis is desirable;
Able to understand and apply risk management concepts in areas of direct responsibility desirable;
Strong verbal and written communication skills;
Ability to exercise independent judgment to determine methods and procedures on new assignments; and
Detail oriented with strong troubleshooting capabilities.
Biological Dynamics is an equal opportunity employer.