Manager, Research & Development, Drug & Delivery Systems
Nice Pak Products
: $177,070.00 - $177,070.00 /year *
: Non-Executive Management
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Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 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 Manager, Research & Development is as technical leader in all aspects of product development of drugs and delivery systems within PDIS Interventional Care (FDA regulated) business. He/she will be a key member of a cross functional Core Team charged and be responsible for managing multiple, interrelated work-streams, to ensure all critical milestones are met and deliverables completed on time and budget. The Manager, Research & Development will interact with the other cross-functional team members as well as extended team members from across the organization, ensuring strong connectivity, provide leadership and technical guidance. Finally the Manager, Research & Development will foster and develop a team of direct reports to exceed the expectations on core competencies and customer connectivity. 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 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 PDIs mission. She/he 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 PDIs 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, engineers, 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 OTC 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 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 departments direct interface with alliance partners, with responsibility for risk assessment, financial and strategic planning, and project guidance responsibilities to protect the Companys 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 PDIs 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 1. Meet key PDI business targets for Interventional Care Product Development and other initiatives projected to contribute revenue and profit growth. 2. Support, recruit, develop and retain an effective team; act as a model for the R&D organization. Requirements QUALIFICATIONS EDUCATION/CERTIFICATION: Minimum MS degree in Chemistry, Engineering, or related scientific discipline required. PhD degree preferred. REQUIRED KNOWLEDGE: FDA OTC drug product development and process awareness. EXPERIENCE REQUIRED: 10 years of relevant experience in product development and R&D support, with a demonstrated track record of successful product launches and scientific and leadership responsibilities. 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 NONE: About 20% Lab and 80% office environment LI-PDI LI-SC2 INTENT AND FUNCTION OF JOB DESCRIPTIONS Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system. All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate. In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization. Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law. Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. Please view Equal Employment Opportunity Posters provided by OFCCP here . The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Please refer to the Companys Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.