What are the responsibilities and job description for the Senior R&D Manager - On-market position at Werfen North America?
Werfen
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
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.
Responsibilities
Essential Functions and Responsibilities:
Minimum Knowledge & Experience Required for the Position:
Travel Requirements
Closing
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
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
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.
Responsibilities
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.
- 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
- 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
Travel Requirements
- Approximtely 10% of time
- Expected to travel internationally at least once or twice a year
Closing
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
Salary : $195,000 - $220,000