Research and Development Associate jobs in Paramus, NJ

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

POSITION PURPOSE

 The primary role of the Research & Development Manager is to actively lead a team in support of our product development process and pipeline focused on interventional and patient care (FDA regulated).  You will work closely with PDI colleagues to lead and be responsible for individuals and R&D projects related to formulation feasibility and development as well as technology transfer and commercialization.  As a leader in R&D you will be expected to work in partnership with cross functional team members to ensure critical milestones are completed and deliverables met in support of product identification and implementation.  In addition, you will be developing new capabilities that enhance PDI’s scientific acumen to provide a competitive edge in the healthcare and food service marketplace.

 ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Responsibilities include leading the design, development and execution of R&D programs supporting product development and functional support of the existing Interventional and Patient Care portfolio.
• This includes providing leadership to direct reports and cross functional team members to ensure product development programs are executed timely, compliant and to meet the high standards aligned with PDI’s mission.
• This role will also assist in the leadership and implementation of an organizational structure that supports successful delivery of innovation, both internal and external in the scope and timing defined by PDI’s strategy and business needs and collaborates with all critical cross functions produce high quality products that satisfy customer needs.

 Responsibilities will include, but are not limited to, the following:
 

• Leads and develops high performing technical team of scientists and technicians.
• Provides oversight and direction for individuals and teams responsible for: creating and executing R&D programs and initiatives
• Provides leadership and oversight on technical support as well as direction to activities for R&D initiatives.
• Expert knowledge and strong experience in FDA regulated environment, specifically OTC drugs (NDA and Monographed) as well as Medical Devices product development and life-cycle management.
• Strong knowledge and background in GMP, GLP and GDP requirements and their application in regulated product development areas.
• 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.
• Develops and provides input to program strategies, budgets, timelines, and project/product development plans. Ensures that both, technical and business requirements are managed and met.
• Acts as subject matter expert for Interventional and Patient Care in regulatory, quality, and customer support. Acts as a subject matter expert during Health Authority interactions.
• Participates and supports in due diligence assessments and may serve as the department’s direct interface with alliance partners, with responsibility for risk assessment, financial and strategic planning, and project guidance responsibilities to protect the Company’s interests and resource investments.
• 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 team in successful and efficient execution of department/area goals, and continued strategic capability development/improvement.

Leadership and Management

• Reinforces PDI’s culture and values, and drives change where needed to increase alignment with those goals.
• Identifies departmental needs and assist with recruits/hires/promotes personnel as appropriate.
• Develops staff through coaching, training, and other relevant experiences. Builds high performance teams.

Project Management

• Operates effectively in a multi-tasking, cross-functional environment, including managing network external collaborators and experts
• Analyzes and provides clear direction in areas of ambiguity or uncertainty, maintaining momentum and achieve alignment with cross-functional partners in these areas.
• Demonstrates intellectual agility to work effectively and efficiently in a highly regulated space, exhibiting the ability to identify and assess opportunities for prudent risk taking.
• Develops appropriately proactive resource plans and utilizes staff and other resources effectively to meet area/partners’ needs. Uses appropriate tools to regularly review, measure, modify, and adjust plans and to monitor the efficiency, effectiveness and balance of resources according to evolving business needs and environment.
• Guides internal/external debate and discussions at high levels and focuses constituents towards resolution around strategic and tactical decision making.
• Models good decision making practices and assesses and rewards behaviors consistent with good decision making practices.
• Displays strong analytical and strategic thinking.

People Management

• Provides constructive and timely feedback and coaching to enhance personnel performance.
• Coaches employees on long term career development and leadership capabilities.
• Guides the reallocation of roles and responsibilities across team members to facilitate both goal achievement and personal development.
• Guides and coaches others in managing through change and uncertainty

PERFORMANCE MEASUREMENTS

• Meet key PDI business targets and strategy supporting projects, products and initiatives projected to contribute revenue and profit growth.
• Support, recruit, develop and retain an effective team; act as a role model and change agent for the R&D organization

EDUCATION / CERTIFICATION

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

REQUIRED KNOWLEDGE

• FDA drug product development and process awareness.

SKILLS / ABILITIES

• Excellent communication, interpersonal and project management skills to collaborate on and direct the work of others on assigned projects (including both internal teams and external collaborators).
  • 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, applies and furthers those concepts and techniques to efficiently and effectively resolve scientific/technical issues.
  • Excellent written and verbal communication skills. Capable of influencing opinion and sharing technical information and best practices through effective presentations to internal and external audiences.

WORKING CONDITIONS

• 20% Lab and 80% office environment.

SALARY RANGE

• $110,000 - $130,000

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for the physical and mental well-being of our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. 

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including:  sick & safe leave, vacation, company & floating holidays, paid parental leave as well as summer hours and flex place/flex time options.

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