Director of R&D, Reagents - Orangeburg

Position Summary

The Director of R&D, Reagents is a technical and functional leadership position responsible for accomplishing department/corporate goals in a timely, efficient, and resource-wise manner. This position is responsible for leading content development on our Hemostasis Diagnostics platforms. This individual will be responsible for R&D activities required for new product development and life cycle management from conception through launch. In alignment with the 3-year strategic business objectives, this individual will develop an annual R&D technical plan inclusive of resource- loaded schedules and budget. Promoting an innovative culture and collaborative partnerships within and outside the organization is essential for success in this role. This position reports directly to the VP of Reagent Development.

Responsibilities

Key Accountabilities:

• Utilizing DFSS tools and principles, provide technical leadership/oversight on new product development for automated coagulation/clotting assays on automated hemostasis analyzers.
• Lead scientists and team managers in life cycle management activities for on-market products inclusive of collaborating on risk assessments, regulatory strategy, and design change verification/validation activities.
• Develop and position team managers and technical specialists to ensure success in the achievement of departmental goals and objectives.
• Build and foster collaboration within and outside of the organization to bring awareness of emerging technologies and tools, thereby providing continuous learning opportunities for team members and the broader R&D organization.
• Identify opportunities for team development and growth through working with departments managers, other R&D Directors, and the VP of Reagent Development.
• Collaboratively work with Product Support and Operations on Design Transfer activities.
• Establish frequent and transparent department level communication to share important company, goal, and project updates.
• Communicate and coordinate with Marketing and Strategic Business Unit(s), affiliates, and distributors in the identification of new product opportunities and provide guidance as to their technical and economic feasibility and understanding any special requirements.
• Collaborate and communicate with associated groups within R&D, Quality Assurance, Operations, Marketing, and Sales to develop yearly strategy on products that meet regulatory and end-user requirements.
• Develop and recommend annual objectives, plans, and budgets for research and product development activities which address the immediate, short-term, and long-term departmental goals.
• Establish and maintain adequate records of technical information, formulas, process, methods, and standards.
• Appraise technical research accomplishments against objectives, assuring or directing the proper shifts in approach and emphasis when needed.
• Utilize the Patent Board to help maintain the company’s intellectual property portfolio.
• Collaborate with Project Management team to ensure cross-functional information sharing and resource allocation for immediate, short, and long-range projects.
• Performs other duties and responsibilities as assigned.
  
  

Reasonable accomidations may be made to enable individuals with disabilites to perform these essential functions.

Networking/Key Relationships

• Key process related stakeholders, Executive Management, Sales, Marketing, Customer Service, Corporate Supply Chain, Distribution, Finance, Logistics and Plant Operations.
  
  

Skills & Capabilities

• Deep technical knowledge on new product development
• Demonstrated strategic thinking, problem-solving and organizational leadership skills
• Strong collaboration and team-building skills
• Excellent oral and written communication skills
• Energetic, forward-thinking, and creative with the highest ethical standards
• Articulate with an ability to relate well with people at all levels of an organization
• Collaborative leader who is trustworthy and able to share information cross-functionally
• Excellent facilitator who is experienced in resolving conflicts
• Ability to balance strategic thinking and tactical implementation
• Ability to quickly adapt to situations and environment
• Leadership role model with capacity for coaching/developing colleagues as well as the team.
• Ability to drive change.
• Demonstrated passion for customer and patient focus.
  
  

Qualifications

Minimum Knowledge & Experience for the position:

• Education: Master’s or Ph.D. in Chemistry, Biochemistry, Biology, or Molecular Biology.
• Experience: A minimum of 15 years relevant experience and 10 years’ experience in managing scientists and/or engineers at various levels. Solid experience in IVD product development required. Business related experience in a medical device or pharmaceutical industry is strongly preferred. Firm understanding and recent application of design of experiments (DOE), Monte Carlo simulations, descriptive statistics, and statistical hypothesis testing is required. Firm understanding of robust product design and development is required. Demonstrated experience in QC Method development and method validation is required. Demonstrated experience in Reagent Design Transfer is required.
  
  

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

Travel Requirements

5% of the time

The annual salary range Werfen reasonably expects to pay for the position is $210,000 to $250,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.