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Purpose of the Position: Design, development and validation of DNA array-based products for the detection, identification and quantification of nucleic acids and the diagnosis of human and animal diseases. Translate product requirements into test performance specifications, develop technical solutions to product design and performance issues.

Essential Duties and Responsibilities (other duties may be assigned):

• Design and test genomic targets and probe sequences to allow the specific detection of candidate genes, mutations and/or expressed gene transcripts.
• Design and evaluate prototype products
• Perform the optimization and characterization of product design and manufacturing processes.
• Plan, coordinate and document internal verification and external validation of product performance.
• Plan, coordinate and document method validation studies.
• Document all aspects of product design and development to meet ISO standards and FDA QSR requirements.
• Work with internal project management to obtain appropriate resources and coordination with other departments and projects to assure timely completion of project tasks.

Supervisory Responsibilities: May direct the work of Research Associates

Qualifications:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.
• Experience with product design and development of nucleic acid-based assays for disease detection and diagnosis or development of pharmaceutical products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor’s office market.
• Organizational, planning and detail follow-up skills required.
•  Experience in planning, coordinating and documenting controlled studies, including protocol.
• Training and experience in basic statistical analysis and Design of Experiment methodology preferred.
• Ability to work in a  team environment.
• Ability to handle and resolve conflicts and work under stressful conditions
• Demonstrated ability or track record of successful results.
• Ability to understand complex scientific concepts.
• Demonstrated ability to be flexible and resourceful.  Good communication and diplomacy skills required.
• Knowledge of safety precautions required for working with blood borne pathogens at Biosafety Level 1 and 2.

Education and Experience: M.S. degree and 5 or more years of relevant experience, or a Ph.D. in molecular biology,biochemistry or a related field.  In rare occasions, a highly qualified and experienced individual with a B.S. degree and 10 or more years of relevant experience will qualify as a Senior Scientist.

Language Skills:  Must be proficient in writing, and communicating in the English language. 

Mathematical Skills:  Must be consistent with graduate level education. Knowledge of basic statistics relevant to interpretation and analysis of scientific data, including characterization of assay performance is required; knowledge of statistical-based Design of Experiments methodologies is desirable.

Reasoning Ability:  Good problem solving, judgment and decision making skills are required.

Certifications, Licenses, Registrations:

Physical Demands:  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance.  Work entails occasional lifting and/or moving up to 25 pounds.  Work occasionally requires travel between buildings.  This is typically completed by foot or by car.

The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.

Work Environment:  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration.  The noise level in the work environment is usually moderate.