Werfen North America · 2 days ago
Research Associate IV
San Diego, CA
Full-time
Onsite
Senior Level
$86K/yr - $110K/yr
5+ years expWerfen North America is a family-owned, innovative company specializing in diagnostics. The Research Associate IV will contribute to the development and transfer of new assays, performing complex laboratory techniques and providing guidance to junior team members.
HealthcareManufacturingHealth Care
Responsibilities
Designs and executes complex experiments for assay development, transfer, and on-market sustaining support; performs data analysis and interpretation
Develops and executes protocols for the generation of results using multiple technologies (e.g. ELISA, Chemiluminescence, Indirect Immunofluorescence, Bead-based assays)
Establishes acceptance criteria by analyzing current data and generating additional data, taking into consideration regulatory guidance documents and technical literature
Independently plans and performs a variety of laboratory bench work
Leads or supports root cause investigation activities for R&D or on market assays using structured problem solving methodologies (e.g. DMAIC) and implements the associated corrective actions
Performs statistical analysis for the design of experiments (DOE), analysis of data, and process monitoring
Executes and designs process characterization studies (e.g. in process stability, mixing parameters) to support manufacturing specifications and the identification of critical to quality attributes
Ensures appropriate assay specifications are included in the manufacturing documentation to enable robust product manufacturing
Conducts guard banding and process characterization studies for assays in collaboration with R&D and manufacturing teams
Coordinates initial production of assays transferring from R&D into manufacturing
Stays current on related scientific literature and regulatory/quality documents
Understands and executes all relevant quality documents. Writes new manufacturing documents, Standard Operating Procedures, CAPAs, and other quality documents and processes documents through the company enterprise resource planning (ERP) system, SAP
Coordinates aspects of the design control process related to development and transfer by conducting meetings, drafting design control documents and design reviews according to appropriate SOPs independently
Generates or supports design control deliverables such trace matrices, manufacturing documents, and transfer deliverables
Coordinates and facilitates assay development and transfer related meetings involving cross-functional groups by preparing agendas, meeting minutes and action item tracking
Develops and maintains training materials and providing training to other staff
Coordinates tasks associated with assay development accountabilities for other team members. Includes the ability to prioritize workload and potential changes in required work, for self and for team, as required
Interprets and utilizes information from V&V reports
Coordinates maintenance and/or calibration process equipment and instrumentation, including tracking and traceability for GLP studies and preventive maintenance and calibration
Coordinates and facilitates the upkeep of laboratory equipment and other supplies required to avoid interruptions to workflow and maintain material availability
Accurately maintains lab records and scientific reports with attention to detail. Proficient in data collection and analysis independently
Provides support to department management on a variety of administrative activities, which may include schedule coordination, training, distribution of workflow through the team/department, serving as a subject matter expert, etc
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
Support for regulatory submissions, audits, and inspections
Interacts effectively, using tact and diplomacy, with diverse personalities including colleagues, collaborators and outside vendors, as needed
Qualification
Required
Bachelor's degree in related field (ex: Biology, Microbiology, Cellular Biology, Biochemistry) required plus at least 8+ years of experience working in a research and/or manufacturing lab required
Master's degree in related field (ex: Biology, Microbiology, Cellular Biology, Biochemistry) required plus at least 5 + years of experience working in a research and/or manufacturing lab required
Ph.D. degree in related field (ex: Biology, Microbiology, Cellular Biology, Biochemistry) required plus at least 2 + years of experience working in a research and/or manufacturing lab required
Experience working in the field of immunology diagnostic research and/or medical device development strongly preferred
Proficient using structured problem solving and basic statistical methods
Deep knowledge and experience following lab protocols, safety requirements and procedures
Demonstrated experience using a variety of laboratory equipment
Understanding of medical device regulatory requirements
Adaptability and Resilience
Organizational and multi-tasking skills
Team Focus & Collaboration
Initiative
Detail Oriented
Time Management
Good Communication
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation
Sick leave
Participation in a commission plan
Eligible for a performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase