Research Associate IV

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

Job Summary

The Research Associate IV contributes to the current and future Inova Diagnostic product lines by designing and performing a wide variety of laboratory techniques to assist in the development and transfer of new assays and/or improve on market assays. The individual in this role will be instrumental in driving robustness in assays being transferred from R&D into manufacturing. He/she is responsible for working independently to complete complex laboratory activities, where analysis of situations or data requires an in-depth evaluation of a variety of factors. The individual will exercise judgment in selecting methods and evaluation criteria for obtaining results. He/she will serve as a technical lead and provides training and guidance to junior members of the team and provides administrative support to department management, as needed. The person in this role will follow good laboratory documentation practices and in accordance with Standard Operating Procedures and other Research and Quality System requirements.

Key Accountabilities

• 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.

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

Networking/Key relationships

• Research & Development Teams
• Manufacturing Teams
• Quality Teams
• Sales and Marketing Teams
• Project Management Teams

Minimum Knowledge & Experience for the position:

Education:

• 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.

Special skills or knowledge:

• 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.

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

Skills & Capabilities:

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

Travel requirements:

Less than 5%

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 annual base salary range for this role is currently $86,000 range to $110,000 range. 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.

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

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.

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

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

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.

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