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System One R&D Manager in Montvale, New Jersey

Title: R&D Manager

Location: Park Ridge, / Montvale NJ area

Schedule: M-F Full Time

Type: Direct Hire

Responsibilities:

  • Manage the design, development and execution of R&D programs supporting product development and functional support of the an interventional and patient care product portfolio.

  • Provide leadership to direct reports and cross functional team members to ensure product development programs are executed in a timely manner.

  • Assist in the leadership and implementation of an organizational structure that supports successful delivery of innovation, both both internally and externally.

  • Lead and develop a high performing technical team of scientists and technicians.

  • Provide oversight and direction for individuals and teams responsible for: creating and executing R&D programs and initiatives

  • Expert knowledge and strong experience in FDA regulated environment, specifically OTC drugs (NDA and Monographed) as well as Medical Device product development and life-cycle management.

  • Strong knowledge and background in GMP, GLP and GDP requirements

  • Strong knowledgeable and versed in formulation development, process development; developing and documenting the data needed for drug related regulatory filings; and managing projects/products post commercialization.

  • Develop and providesinput to program strategies, budgets, timelines, and project/product development plans.

  • Acts as subject matter expert for Interventional and Patient Care in regulatory, quality, and customer support.

  • Participates and supports in due diligence assessments

  • Builds and maintains strong working relationships with relevant internal and external partner groups (including Microbiology, Analytical Chemistry, Marketing, Manufacturing Operations, Regulatory, Clinical Affairs, and Quality, as well as external testing partners), ensuring that activities are managed collaboratively, efficiently, and effectively.

  • With direction from senior management, guides R&D team

  • Leadership and Management

  • Project Management

  • People Management

    Requirements:

  • Minimum MS degree in Chemistry, Engineering, or related scientific discipline required. PhD degree preferred.

  • FDA drug product development and process awareness.

  • 10+ years of relevant experience in product development and R&D support.

  • Sound knowledge of related aspects of Infection Prevention and Interventional Care research, development, and commercialization processes.

  • Established knowledge of applicable global Interventional Care regulatory standards (FDA, Notified Body, etc.).

  • Experience preparing technical and scientific sections of regulatory submissions and interacting with regulatory authorities on technical matters.

  • Mastery of the scientific/technical concepts and techniques.

  • Excellent written and verbal communication skills.

    Nasal decolonization, interventional care, skin, antiseptics, hand sanitizer, FDA, OTC

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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