Research Associate III

Werfen; San Diego (CA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k with employer match

Paid vacation and sick leave

Commission plan (sales roles)

Job summary

Werfen is seeking a Research Associate III in San Diego to join a collaborative R&D team focused on advancing diagnostic assay development through verification and validation. You will own complex development projects, contribute to design controls, and serve as a technical resource across R&D, Manufacturing, Quality, and Operations.

The role emphasizes independent work with strong cross-functional collaboration, adherence to SOPs, and engagement in data generation and presentation for

Qualifications

• Bachelor's degree in Biology, Microbiology, Cellular Biology, Biochemistry, or related field.
• 5+ years of experience in a research lab or equivalent.
• Knowledge of immunology and diagnostic lab techniques.
• Understanding of medical device regulatory requirements.

Responsibilities

• Trains junior team members in routine department activities (buffers, pH checks, sample prep).
• Executes established protocols for sample results using ELISA, chemiluminescence, IF techniques.
• Maintains and calibrates lab equipment and tracks GLP studies.
• Supports design of standard work and manufacturing records under supervision.

Skills

Adaptability

Organizational skills

Team collaboration

Initiative

Detail oriented

Time management

Communication

Education

Bachelor of Science in Biology / Microbiology / Cellular Biology / Biochemistry

Job description

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.

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.

Overview

Position Summary:

Join a collaborative and highly visible R&D team where you will play a key role in advancing diagnostic assay development through verification and validation. As a Research Associate III, you'll take ownership of complex development projects, contribute to design control and process improvement activities, and serve as a technical resource for both your team and cross-functional partners. This is an opportunity for an experienced research associate who enjoys working independently while collaborating closely with colleagues across R&D, Manufacturing, Quality, and Operations.

Assay Development:

Focus on 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.

Responsibilities

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

Qualifications

Skills & Capabilities:

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

Education

Minimum Education, Experience, Skills and Knowledge:

• 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.

The annual base salary range for this role is currently $70k to $95k. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

International Mobility

• Not required

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 [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com