Manager, R&D - Assay Feasibility

Werfen; San Diego (CA); On-site; USD 130,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with employer match

Paid vacation and sick leave

Job summary

Werfen is seeking a Manager, R&D - Assay Feasibility in the Autoimmunity division to lead a team of researchers focused on biomarker discovery, assay development, and clinical autoimmunity studies. Reporting to the Director of R&D, you will drive feasibility studies, evaluate novel biomarkers, and guide cross-functional initiatives in a regulated diagnostics environment.

The ideal candidate has deep expertise in clinical autoimmunity, assay development, and biomarker evaluation, with a proven

Qualifications

• Bachelor's degree in biology or life sciences required.
• Minimum 10 years of experience in a regulated medical device environment (IVD/autoimmunity) preferred.
• Experience leading junior management staff for high performing teams.
• Strong understanding of design controls, quality systems, and regulatory requirements.

Responsibilities

• Lead feasibility studies and biomarker discovery in autoimmune diagnostics.
• Provide scientific leadership across cross-functional autoimmunity programs.
• Mentor and develop a team of research associates and managers.
• Collaborate with Quality, Regulatory, Marketing, and Manufacturing teams to ensure product success.

Skills

Leadership

People management

Regulated environment

Biology knowledge

Education

Bachelor's degree in biology or related life sciences

Tools

ELISA

IFA

Multi-analyte technologies

Job description

Would you like to visit the Werfen website for North America?

Country

United States

Shift

1st

About the Position

Introduction

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

Job Summary

Join Werfen's Autoimmunity business as a Manager, R&D - Assay Feasibility where you will lead a team of research associates focused on advancing innovation in autoimmune diagnostics through biomarker discovery, assay development, and clinical autoimmunity research. Reporting to the Director of R&D, this role is responsible for driving feasibility studies, evaluating novel biomarkers, supporting assay development programs, and providing scientific leadership across cross-functional initiatives. The ideal candidate brings deep expertise in clinical autoimmunity, assay development, and biomarker evaluation, along with a proven track record of leading high-performing teams within a regulated diagnostics environment. Success in this role requires a collaborative, communicative, and innovative leader who can foster team engagement, build strong cross-functional partnerships, and introduce new approaches to identifying and screening novel biomarkers that support the development of industry-leading autoimmune diagnostic solutions.

Responsibilities

Key Accountabilities

Management Accountabilities

• Responsible for the overall performance of assigned department(s), including a welltrained and high performing, engaged workforce.
• Management and leadership to people managers and individual contributors within assigned span of control.
• Collaborates in deciding strategies and department goals to achieve company objectives
• Ensures staff understand objectives and expectations related to them.
• Responsible for effective collaboration between assigned department and other departments and Werfen entities.
• Collaborates in managing department headcount to ensure effective resource planning, including approval of all recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management.
• Determines the need for new or improved processes or resources. Delegates responsibility, or may directly author, implement, to ensure maintenance of departmental procedures, work instructions, and templates associated with the department activities.
• Responsible for department metrics and data collection methodologies, including interpreting data to make recommendations to Department Senior Leadership. Prepares and presents reports and other presentations.
• Manages and influences department and cross-functional projects.
• ensures effective use of company's performance management, program including setting expectations, providing timely and meaningful feedback, ensuring understanding, holding staff accountable, while supporting employees' development goals.
• Ensures regular and meaningful communication throughout the department, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication.
• Develops and delivers effective updates to Department Senior Leadership in formats appropriate for the topic and situation.
• Manages and leads lower-level management staff to ensure high performing teams and department operations. Includes accountability to Werfen's People Manager Competencies and Expectations.
• Monitors department personnel and operations to prevent employee issues. Proactively manages employee relations issues; uses professional judgement in consulting with Department Senior Leadership and Human Resources.
• Ensure risks to the business and employees are identified and mitigated through effective controls.
• Promotes a culture that supports and ensures team/department compliance with applicable Autoimmunity SOPs, ISO, FDA and other Quality System Regulations, as well as Werfen's Code of Ethics, Human Resources, Environmental, Helath & Safety, and other regulatory and administrative laws and policies.
• Represents the AID management team and reflects Werfen Values as a role model to employees, suppliers, and customers.

Research & Development Accountabilities may include:

• Collaborates in research & development operations to identify and develop best in class products, for autoimmune diseases and related conditions, that meet quality requirements, customer demand and profitability goals. Includes all activities related to identification of new biomarkers and development of products within assigned area(s).
• Participates in successful collaboration with external organizations (KOLs, customers, etc.) and other Werfen entities.
• Manages technical issues, root cause corrective action analysis, customer complaint investigation support, design of experiments, new product technology transfer support, and supplier technical assistance.
• For new equipment, oversees the specification, selection, vendor contacts, installation, documentation, validation and training.
• Participates in scientific meetings and exhibitions and reports on new trends in autoimmunity research fields.
• Facilitates the improvement of products by investigating formulation changes or manufacturing procedures to improve product quality and/or optimize manufacturing processes.
• Maintains knowledge of academic and commercial technology trends and competitive developments as input into strategic plans; acts as a key scientific resource to other departments.

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

Networking/Key relationships

• Research & Development teams
• Quality, Regulatory and Product Complaints teams
• Marketing & Service teams
• Manufacturing teams
• Autoimmunity Senior Leadership
• Human Resources, Finance, Facilities, IT, EH&S

Qualifications

Minimum Knowledge & Experience for the position:

• Education: Bachelor's degree in biology or other life sciences related field required. Masters degree preferred.
• Experience: A minimum of 10 years of experience within a regulated medical device environment required, preferably in IVD or autoimmunity.
• Experience in different diagnostic platforms, such as ELISA, indirect immunofluorescence (IFA), and/or multi-analyte technologies preferred.
• Proven track record of taking medical device products from inception through development and successful commercialization.
• At least 5 years of experience managing and developing junior level management staff required.
• Proven track record of building and managing successful business operations and high performing teams required.

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

Skills & Capabilities:

• Deep understanding of design control procedure, quality system regulations and relevant regulatory requirements for the design, development and commercialization of diagnostic technologies and products.
• Strong understanding of life sciences related compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, or other regulations and standards).
• Ability to analyze and interpret scientific data, technical journals, financial reports, and government regulations required.
• Ability to decide operational plans to successfully achieve department and company goals.
• Understanding of business and employment laws and experience monitoring for compliance and prevention of employee relations issues and business risks.
• Advanced ability to constructively prevent and resolve conflicts.
• Critical thinking capability and decision making.
• Strong ability to function effectively with ambiguity in a rapidly changing environment.
• Strong influencing and negotiation skills, while building collaborative relationships and maintaining strong, positive working relationships.

Compensation

The annual base salary range for this role is currently $130k to $165k. 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.

Less than 5% of the time

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.