Position Summary:

This position participates in the development of current and future Inova Diagnostic product lines by performing a variety of laboratory activities to assist in the development of new assays and/or the identification of potential new biomarkers.  As fully competent and experienced Research Associate, this position will use their judgement and expertise to work on a wide variety of research and development activities, including data analysis, evaluation and recommendations.  Demonstrates judgement in selecting methods and techniques for obtaining results.  Generally, receives little instructions on day-to-day work, and general instructions on new assignments.  Provides training to others, as needed.

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:

• Trains junior members of the team in tasks associated with routine department activities, such as making buffers, checking pH solutions, diluting samples, etc.
• Independently executes established protocols for the generation of sample results utilizing multiple technologies. (ex: ELISA, Chemiluminescence, Indirect Immunofluorescence), may assist in protocol design.
• Independently performs basic conjugation/coupling and other calculations such as dilution factors and material concentrations.
• May participate in the execution of external studies under minimal supervision.
• Stays current on related scientific literature that could be applied to assay development and/or the optimization of new biomarkers and routes key findings to department management.
• Maintains and/or calibrates process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration.
• Participates in the design of protocols for standard work and drafting of manufacturing records under supervision
• Participates in troubleshooting and technical discussions.
• Participates in assay development related meetings involving cross functional groups.
• Participates in certain aspects of the design control process, according to appropriate SOPs under supervision.
• Participates in the execution of quality documents and coordinate revision changes through the electronic change management (ECO) system, as needed.
• 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 including colleagues, collaborators and outside vendors.  
• Assists with successfully implementing changes in operational priorities.
• Accurately maintains lab records and scientific reports with attention to detail. Performs data collection and analysis.
• Follow Standard Operating Procedures (SOPs) and other documentation to perform job functions.
• Participates in generating and presenting data slides using group templates.
• 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.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Budget Managed:

• No budgetary responsibility.

Internal Networking/Key Relationships:

• Research & Development Teams
• Manufacturing Teams
• Quality Control Team
• Technical Support Team

Skills & Capabilities:

• Adaptability and Resilience
• Organizational and multi-tasking skills.
• Team Focus & Collaboration
• Initiative
• Detail Oriented
• Time Management
• Good Communication

Minimum Education, Experience, Skills and Knowledge:

Education:

• Bachelor's degree; Bachelor of Science degree in Biology, Microbiology, Cellular Biology, Biochemistry, or similar field of study required.

Experience:

• 5+ years’ experience working in a research lab or an equivalent combination of education and experience.

Special skills or knowledge:

• Knowledge of immunology, including relevant laboratory techniques for diagnostics.
• Knowledge and experience in general lab protocols.
• Knowledge of basic laboratory safety requirements and procedures.
• Knowledge and experience with basic laboratory equipment.
• Understanding of medical device regulatory requirements.

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

International Mobility:

• Not required

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 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 and 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 and 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 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The hourly range for this position is currently $34-$46. 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.