Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

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:

• Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred.
• Regulatory Affairs Certification preferred.
• Ten (10) years of work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which five (7) should be Regulatory.
• Experience in regulatory submissions including 510(k) and notified body technical documentation required.
• Experience in international registrations required.
• Project management experience preferred.

Skills & Capabilities:

• Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
• Advanced knowledge knowledge of regulatory intelligence tools and methods, with ability to interpret and apply regulations. Knowledge of electronic publishing/file management system.
• Advanced verbal and written communication skills including proofreading, scientific writing, presenting positive presusive arguments, and presentation to various organizational levels.
• Advanced skills in leadership, influence, and negotiation with the ability to build collaborative relationships.
• Advanced ability to organize and complete multiple assignments in a fast-paced environment in a timely, accurate manner as a team member and/or as an individual contributor.
• Advanced analytical skills with ability to develop proactive and creative approaches to problem-solving including creating regulatory strategies that balance short and long-term objectives.
• Advanced ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.

Travel Requirements:

Limited travel required.

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.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

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