Senior R&D Manager - On-market

Werfen North America; Orangeburg (NY); On-site; USD 195,000 - 220,000; Full time

Job summary

Werfen North America is seeking an experienced R&D Leader to manage on-market assays, algorithms, reagents, and controls, ensuring compliance with design controls and regulations. You will plan, organize and implement programs, communicate objectives, and supervise a technical staff to achieve budgets and timelines.

Ideal candidates have a Master’s or Ph.D. with 7+ years of management experience in R&D or product development, with international travel and cross-functional collaboration across

Qualifications

• Master’s or Ph.D. degree required.
• Seven years managing scientists or engineers at various levels; or advanced substitutions allowed.

Responsibilities

• Manages R&D personnel responsible for investigations on released products due to complaints, CAPA, or continuous improvement efforts.
• Supports transfer of technology from R&D to manufacturing within US and outside US sites.
• Interacts cross-functionally to meet country regulatory requirements and ensure GMP documentation.

Skills

Technical leadership

Communication

Scientific principles

CAPA procedures

Higher duties experience

Education

Master’s degree

Ph.D. degree

Job description

Werfen is a global family‑owned diagnostics company, founded in 1966 in Barcelona, Spain. We lead worldwide in specialized diagnostics in Hemostasis, Acute Care, Transfusion, Autoimmunity, and Transplant. Our OEM line develops and manufactures custom assays and biomaterials across 30 countries and over 100 territories.

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 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.

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.
• 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, from initial feasibility to consideration for development.
• Ensures appropriate and adequate equipment and material resources are available to advance the projects and achieve goals and objectives.
• Fosters a creative, professional climate that maximizes 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 the position requires.

Networking / Key Relationships

• 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, and cross‑functional relationship building.
• Strong oral and written communication skills.
• Ability to apply scientific principles, theories, and concepts in the field of expertise.
• Familiarity with complaint and CAPA procedures.
• Demonstrated ability to perform duties and responsibilities higher than an R&D Manager level.

Qualifications

• Education: Master’s or Ph.D. degree.
• Experience: Seven years managing scientists or engineers at various levels; or
  • Master’s plus 15 years of relevant experience;
  • Ph.D. plus 10 years of relevant experience;
  • Product or Project specific experience may substitute for higher degree.
• Management has discretion to substitute relevant work experience for a degree and/or make exceptions to the years of experience requirement.

Travel Requirements

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

Compensation

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

Equal Opportunity Employer

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based on 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.