Manager, R&D - Assay Feasibility

Werfen • San Diego, CA

1d • $130,000 - $165,000

About The Position

Werfen is hiring a Manager, R&D - Assay Feasibility to lead a team of research associates in its Autoimmunity business. The role advances autoimmune diagnostics through biomarker discovery, assay development, and clinical autoimmunity research. Reporting to the Director of R&D, the manager leads feasibility studies, evaluates novel biomarkers, supports assay development programs, and provides scientific leadership across cross-functional initiatives. The position calls for expertise in clinical autoimmunity, assay development, and biomarker evaluation, together with experience leading teams in a regulated diagnostics environment.

The manager is responsible for the performance and operations of assigned department(s), including team engagement, staffing and development, resource planning, budgets, department processes, metrics, and reporting. The role collaborates with other departments and Werfen entities, manages department and cross-functional projects, and promotes compliance with applicable quality, regulatory, ethics, human resources, and safety requirements.

R&D work includes identifying and developing products for autoimmune diseases and related conditions, collaborating with external organizations and Werfen teams, supporting technical investigations and product transfer, and keeping current on scientific and competitive developments. The position may oversee equipment specification, selection, installation, validation, documentation, and training. Travel is less than 5% of the time. The annual base salary range is $130,000 to $165,000. The role is eligible for medical, dental, and vision insurance, a 401(k) with employer match, paid vacation and sick leave, and a performance-based bonus.

Requirements

• Bachelor’s degree in biology or another life sciences-related field; management may substitute relevant work experience for a degree or make exceptions to experience requirements.
• At least 10 years of experience in a regulated medical device environment; IVD or autoimmunity experience is preferred.
• At least 5 years of experience managing and developing junior-level management staff.
• Proven track record of taking medical device products from inception through development and successful commercialization.
• Proven track record of building and managing successful business operations and high-performing teams.
• Deep understanding of design control procedures, quality system regulations, and applicable regulatory requirements for the design, development, and commercialization of diagnostic technologies and products.
• Strong understanding of life sciences compliance requirements, such as US Quality System Regulations, EU IVDR, ISO 13485, and ISO 14971.
• Ability to analyze and interpret scientific data, technical journals, financial reports, and government regulations.
• Ability to determine operational plans to achieve department and company goals.
• Understanding of business and employment laws, and experience monitoring compliance and preventing employee relations issues and business risks.
• Advanced ability to prevent and resolve conflicts constructively.
• Critical thinking and decision-making capability.
• Ability to work effectively with ambiguity in a rapidly changing environment.
• Strong influencing and negotiation skills, with the ability to build collaborative and positive working relationships.

Nice To Haves

• Master’s degree.
• Experience with diagnostic platforms such as ELISA, indirect immunofluorescence (IFA), and/or multi-analyte technologies.
• Experience in IVD or autoimmunity.

Responsibilities

• Lead research associates working on biomarker discovery, assay development, and clinical autoimmunity research.
• Drive feasibility studies, evaluate novel biomarkers, and support assay development programs.
• Manage the performance, engagement, training, development, assignments, workload priorities, and performance management of department staff.
• Collaborate on department strategies and goals, ensure staff understand expectations, and coordinate effectively with other departments and Werfen entities.
• Contribute to headcount and resource planning, including recruitment, selection, coaching, and development activities.
• Provide input into department budgets and monitor expenditures.
• Identify the need for new or improved processes and resources; maintain departmental procedures, work instructions, and templates.
• Manage department metrics and data collection, interpret results, and make recommendations to senior leadership; prepare and present reports and updates.
• Manage and influence department and cross-functional projects.
• Promote regular communication, employee development, accountability, and high-performing teams; proactively address employee relations issues in consultation with senior leadership and Human Resources as appropriate.
• Identify and mitigate business and employee risks through effective controls.
• Promote compliance with applicable Autoimmunity SOPs, ISO and FDA requirements, quality system regulations, Werfen’s Code of Ethics, and relevant administrative, environmental, health, and safety policies.
• Collaborate in identifying and developing products for autoimmune diseases and related conditions that meet quality, customer demand, and profitability goals.
• Collaborate with external organizations, including key opinion leaders and customers, and with other Werfen entities.
• Manage technical issues, root cause and corrective action analysis, customer complaint investigation support, design of experiments, new product technology transfer support, and supplier technical assistance.
• Oversee equipment specification, selection, vendor contacts, installation, documentation, validation, and training for new equipment.
• Participate in scientific meetings and exhibitions and report on trends in autoimmunity research.
• Investigate formulation changes and manufacturing procedures to improve product quality or optimize manufacturing processes.
• Maintain knowledge of academic and commercial technology trends and competitive developments, and serve as a scientific resource to other departments.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan with employer match
• Paid vacation
• Paid sick leave
• Performance-based bonus eligibility for management and select professional roles

What This Job Offers

• Job Type: Full-time
• Career Level: Manager