Research Associate I

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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.

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.