Senior R&D Manager - On-market

Werfen; Orangeburg (SC); On-site; USD 195,000 - 220,000; Full time

Job summary

Werfen is seeking an R&D Manager in Orangeburg, SC to manage on-market assays and support technology transfer to manufacturing. This role requires a Master's or Ph.D. degree with at least seven years of management experience, offering a salary between $195,000 and $220,000.

The successful candidate will lead a team, ensure compliance with regulations, and drive innovation in diagnostic solutions.

Qualifications

• Seven years managing scientists or engineers at various levels.
• Experience with complaint and CAPA procedures.
• Ability to perform duties above R&D Manager level.

Responsibilities

• Manages R&D personnel for product investigations.
• Supports technology transfer from R&D to Manufacturing.
• Ensures compliance with documentation and testing procedures.

Skills

Technical leadership

Problem-solving skills

Effective communication

Education

Master's or Ph.D. Degree

Job description

Job Information

Number: ICIMS-2026-10409

Job function: R&D

Job type: Full-time

Location: Werfen - Orangeburg - 526 Route 303 Orangeburg, New York 10962 United States

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.

Position Summary

Manages and has direct responsibility for all on-market assays, algorithms, reagents, solutions, controls, and calibrators. May assist in new product development assays in accordance with departmental goals. Plans, organizes, and implements assigned programs in accordance with departmental objectives and in full compliance with design controls and applicable regulations. Responsible for detailing and communicating program objectives to assigned personnel, planning, budgeting, and controlling assigned programs to ensure completion in accordance with established procedures, timelines, and budgets.

Essential Functions and Responsibilities

• Manages R&D personnel responsible for investigations on released products due to complaints, CAPA, or continuous improvement efforts.
• Supports R&D and Product Support/Manufacturing personnel in the transfer of technology from R&D to Manufacturing within US and outside of US sites (i.e., internationally).
• Interacts cross functionally (including QA/RA) to ensure country regulatory requirements are met.
• Ensures consistent and compliant documentation, standardized testing procedures, and good manufacturing practice of products.
• Works to provide robust manufacturing methods for routine production.
• Participates in management reviews in long-range company planning concerning new or projected areas of research and advancements.
• Originates major new ideas for company projects and programs, through initial feasibility to consideration for development.
• Ensures appropriate and adequate equipment and material resources are available to advance the projects(s) and achieve goals and objectives.
• Fosters a creative, professional climate that will maximize the contributions of the technical staff.
• Supervises a staff of technical professionals.
• Exercises responsibility to hire, transfer, discharge, or discipline employees in accordance with company policy.
• Conducts performance appraisals and recommends salary actions; implements policies, procedures, and work standards to meet established company goals and objectives.
• Conducts technical meetings with direct reports and top management covering project progress and issues and other matters of major significance to the company.
• Represents the organization as primary contact.
• Conducts briefings and technical meetings for managers of cross functional teams on project progress and issues, other matters important to the company.
• Performs other duties as position requires.
  • Provide updates to senior management as required.

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

Networking/Key Relationships

• Conducts briefings and technical meetings for top management and inter‑organizational managers concerning matters of significance to the company.
• Product Support
• Production Managers
• Quality Assurance
• Regulatory Affairs

Skills and Capabilities

• Technical leadership, problem solving skills including troubleshooting and root cause investigation, effective time management, team management, effective in building cross‑functional relationships and effective communication.
• Strong oral and written communication skills.
• Duties require broad use and application of scientific principles, theories, and concepts in field of expertise.
• Must be familiar with complaint and CAPA procedures.
• Must demonstrate the ability to perform all duties and responsibilities higher than R&D Manager level.

Minimum Knowledge & Experience Required for the Position

• Education: Knowledge acquired through a Master's or Ph.D. Degree.
• Experience: Seven years managing scientists or engineers at various levels and,
  • Master's plus 15 years of relevant experience; or
  • PH.D. plus 10 years of relevant experience.
  • Product or Project specific experience may be a substitute for higher degree.

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

Travel Requirements

• Approximately 10% of time.
• Expected to travel internationally at least once or twice a year.

The annual salary range Werfen reasonably expects to pay for the position is $195,000 to $220,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.

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.