OverviewPosition 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.
ResponsibilitiesEssential 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
QualificationsMinimum 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:- Approximtely 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.
