The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
Ortho Clinical Diagnostics is seeking a Head of R&D, Clinical Lab Menu located in Rochester, NY. This person will provide strategic vision, operational strategy and leadership to a significant segment of our client's business and is accountable for managing the development and performance of an R&D organization. Within this role this leader and subject matter expert will be a change agent, driving a sense of urgency and executing strategy. He/she will direct R&D activities to drive Pipeline opportunities, New Product development, co-development with external partners and Lifecycle improvements of existing products within performance, cost and on-time objectives. Likewise, this person will be expected to pursue opportunities to improve R&D processes to drive a nimble and fast paced business environment. In this role, She/he is accountable for working within designated R&D project budget, allocating resources, and estimating needs for pipeline projects.
Primary Responsibilities The successful candidate will have overall worldwide responsibility for all aspects of Assay Research & Development and Technology Assessment functions (inclusive of development and improvement) as well as being a key member of the Leadership team. She/he will have frequent interactions with the Executive Leadership, other members within the organization, key associations as well as foster relationships with key opinion leaders and institutions around the world. More specifically, she/he will:
Lead Assay R & D activities to ensure high productivity, efficacy, consistent and on-time and in budget delivery of new products and product enhancements.
Lead development and implementation of recruitment, coaching and mentoring strategies for key high potential candidates in the organization to establish and maintain organizational continuity with a clear succession pool for all critical technical and leadership positions.
Partner with Systems/Platform Business Field R & D leader to ensure operations excellence in Assay Menu + Platforms.
Lead appropriate starring and locations of matrix staff to support cross Business Field functions.
Lead continuous technical competency development and mapping to ensure organizational readiness to support business field critical projects.
Active leader on Platform Business Field Lifecycle Team to provide technical and competency insights to aid is forming and guiding BF strategic direction and projects for future.
Pursue opportunities to improve processes and workflow to drive a nimble, fast paced business environment.
Partner with Project Leaders and Product Management Leader to ensure clarity of Strategy and focus on projects.
Enable technologic assessment of potential M&A/L&A targets
B.S. with strong preference for Science, Engineering or Biomedical concentration. Advanced technical degrees strong preferred.
15+ years of development-related experience with regulated in-vitro clinical lab diagnostics inclusive of 5+ yrs assay development including at least 3 years as senior executive in charge of overall assays or systems development programs in an in-vitro clinical lab diagnostics company.
IVD commercial assay development to FDA validation to commercial launch experience.
Business Acumen and Leadership responsibilities in R & D assay development, project management and program management. Critical nature of position requires business, scientific & technical capabilities with business leadership that results in competitive advantage and sustainable commercial success.
Must have in-vitro Assay diagnostics experience with strong preference for Clinical Chemistry and Immunoassay assay/technology formats.
Must have 5+ yrs of managing an R & D organization inclusive of PhD level staff, managers/engineers and contractors.
Must have experience and demonstrated excellence in supporting Regulatory Affairs (thru all aspects of the regulatory and clinical process), Quality Assurance, Manufacturing, Marketing and Customer Service.
Demonstrable track record of bringing new diagnostic Assays from product development through successful market launches, including post-launch product improvements.
Must have experience and proven performance in building 'best in class' R & D corps, loyalty organizations in the IVD industry; Desire large and entrepreneurial experience and performance excellence.
Must have Portfolio Planning and Lifecycle Management experience in IVD markets with assays/reagents and systems - middleware/IT (preferred).
Must have track record of monitoring and improving R & D productivity; must be able to develop metrics that are clear, specific, attainable and foster teamwork and cooperation to a common set of objectives.
Documented experience in obtaining patents and managing an IP portfolio.
Successful track record of compliance with all relevant FDA, ISO, OSHA, EEO, etc. and other international regulations.
Strong mechanical and process skills. An understanding of automation, methods improvement, in-process controls, etc. and how to design for manufacturability
Personable but strong leader who can put together R&D organizations and get the most out of his/her people. A person who engenders a culture of productivity, esprit d' corp and commitment throughout his/her organization.
Ability to flourish in a fast-paced and dynamic environment.
Strong results orientation and change agent. Must be fair, balanced, resilient, decisive and of high authenticity and integrity.
Strong written and oral communication skills as well as the ability to give presentations to a wide spectrum of audiences, both internally and externally.
Ability to build strong relationships across a wide spectrum of internal and external parties including executive leadership, partners, Key Opinion Leaders, Associations/Society's for Clinical Recommendations, etc..
Ability to interact effectively as a member of the senior executive team, contributing to Company issues beyond operations. Ability to work at both strategic levels and day-to-day levels with sales, marketing, operations, QA/QC, and finance.
Strong leadership and team development skills: Ability to resolve issues related to staffing, performance, and discipline.
Work visa sponsorship is not available for this position
For this position we will not sponsor applicants for work visas.
Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at email@example.com
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