Job Summary

This position assists in the development of current and future Inova Diagnostic product lines by performing laboratory activities to assist in the development of new assays and/or the identification of potential new biomarkers.  This position works under the supervision of the R&D management team and performs lab activities of limited scope, following good laboratory documentation practices and in accordance with Standard Operating Procedures and other Research and Quality System requirements. 

Clinical Affairs/Novel Biomarker Discovery:  Focus on early feasibility and novel biomarker discovery.  This includes collaboration with external organizations and key opinion leaders for study design and identification of new opportunities for the organization.

Assay Development:  Focus on feasibility, verification and validation of new assays for commercialization.  This includes execution of defined analytical and clinical studies to support registration and submission to regulatory bodies.

Manufacturing Technical Support:  Focus on technical support to manufacturing and other cross functional teams within the organization.  This includes execution of defined analytical and clinical studies to support design changes and if needed, registration and submission to regulatory bodies.

Key Accountabilities

Essential Functions:

•  Under supervision, uses standard laboratory equipment such as centrifuges,micro-pipettes, balances, pH meters, and other instrumentation to execute a variety of pre-planned lab activities in the development of assays and/or the identification of new biomarkers. 
• Follows standard practices and procedures to execute established protocols for the generation of sample results utilizing at least one technology, under close supervision. (Example: ELISA, Chemiluminescence, Indirect Immunofluorescence).
• Performs lab techniques such as making common buffers and stock solutions, checking pH solutions and diluting samples, as directed.
• Performs standard conjugation/coupling and other calculations such as dilution factors and material concentrations, under direction.
• Maintains and/or calibrates process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration.
• Maintains accurate lab records and scientific reports with attention to detail and ability to gather and organize data under supervision.
• May participate in assay development related meetings.
• Participates in certain aspects of the design control process according to appropriate SOPs under supervision.
• Works safely with hazardous materials under supervision. Informs department management of laboratory equipment needs and other supplies required to avoid interruptions to workflow and maintain material availability. 
• Interacts effectively, using tact and diplomacy, with diverse personalities.
• Adjusts to periodic changes in operational priorities.
• Follows Standard Operating Procedures (SOPs) and other documentation to perform job functions.
• Understands the safety, technical, recordkeeping and Quality Systems Regulations (QSR) aspects of their position.
• Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies. 
• Reflects the values of Werfen and Inova in the quality of work and in working relationships. 

Networking/Key Relationships:

• Quality Teams
• R&D Teams
• Affiliates
• Other Werfen Manufacturer’s Regulatory Teams
• Regulatory Agencies (Domestic and International)
• Professional and Technical Organizations

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree in biology, microbiology, cellular biology, biochemistry, or related field required.

Experience:

• 1-2 years of experience working in a research laboratory experience required, preferably in autoimmunity and/or medical devices.

Special skills or knowledge:

• Knowledge and experience in general lab protocols.
• Knowledge of basic laboratory safety requirements and procedures.
• Knowledge and experience with basic laboratory equipment.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Work Environment:

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. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific and product data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone, pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk, hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 50 pounds. The noise level in the work environment will vary but is usually moderate.

Travel requirements:

None

The salary range for this position is currently $20- $27/hr. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.