Description
Essential Functions:- Work under the direct supervision of R&D management to achieve technical and business objectives within the scope of the overall projects.
- Identify, test, and implement solutions to defined technical and project issues based on scientific knowledge, evaluation of the scientific literature, and laboratory research.
- Develop and validate new genomic assays based on proprietary technologies.
- Perform laboratory studies to establish the design of multiplex molecular assays in order to meet project schedules.
- Design protocols and perform and lead experimental studies to evaluate and document the performance of prototype products relative to product performance and customer requirements.
- Analyze data, evaluate results, form conclusions, and provide and/or implement product, process, or documentation improvements.
- Design and direct experiments to be performed by Research Associate-level employees; analyze and communicate data resulting from these experiments.
- Document experimental protocols, results of studies and product design/development history in the form of laboratory notebook entries, written reports and/or company presentations. Documentation must meet ISO standards, FDA QSR (SOPs, WI, etc.) requirements and/or protection of company intellectual property requirements.
- Prepare product development deliverables per design control policy.
- Work closely with cross-functional team members in a collaborative environment.
- Develop project and work plans.
- Adjust work schedule to meet time-sensitive project milestones.
Nature and Scope:
Participates with team members to design, develop and test molecular diagnostic assays. Works in the lab and coordinates activities with team members and collaborators. Develops an efficient work plan for the achievement of goals and able to develop novel solutions to overcome obstacles. Maintains a high quality notebook and carefully documents work results.
Education:
A Ph.D. in Biochemistry, Microbiology, Molecular Biology, or a related field and 3-5 years relevant experience, preferably in the clinical diagnostic products industry. Alternatively, an M.S. degree in one of these fields and 5+ years of relevant industrial experience will be considered.
Experience:
- Previous experience working in a commercial IVD product development setting is highly preferred.
- Demonstrated ability to solve technical problems in an assay development and test validation environment.
- Prior experience working in a QSR-compliant environment required.
- Prior experience in all aspects of developing and commercializing new clinical molecular diagnostic products a plus.
- Experience in developing and using new laboratory automation, and molecular biology methods desirable.
Key knowledge includes:
- Broad knowledge of molecular biology and genomic analysis methods.
- In depth knowledge of RNA analysis methods.
- Advanced technical writing skills to produce reports and QSR documents.
Key skills/abilities include:
- Must have excellent technical and communication skills with experience in successful execution of scientific experiments and completion of projects.
- Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
- Excellent verbal and written communication skills and the ability to interpret and summarize scientific results in a clear, concise, accurate manner.
- Demonstrated ability to identify, evaluate, and solve problems.
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.
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.
Working Conditions:
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-borne pathogens, automated equipment, and moderate levels of noise and vibration. The noise level in the work environment is usually moderate. Limited travel is required.