Director, Research and Development

Overview: Provide the development, scale-up, and technical support functions for new and existing products. Provide technical and scientific leadership in the areas of formulation, process development, and technical support for all products.Responsibilities:
Direct formulation and scale-up activities for all new products. Provide ideas & guidance to formulation scientists for formulation and process development. Demonstrates ability to understand the patent claims and recommend resolutions and new approaches to work with Legal Department for formulation and process design. Review and approve batch records for pilot and submission batches. Maintain and provide all formulation/manufacturing documentation for ANDA’s and answer any questions from regulatory authorities
Coordinate product development activities with analytical development, regulatory affairs, biopharmaceutics, process development, manufacturing, and marketing and provide expertise and recommendations where needed. Ensure that complete written reports are produced in support of new product development and that steps taken are in conformance with cGMPs and current FDA regulations and guidelines. Organize/make improvements to the formulation and pilot plant facilities and equipment including new equipment purchases. Organize/make improvements to the R&D warehouse area to maintain the product inventory. Consistently facilitate progress on project(s) through collaborations with the relevant functional areas in the corporation. Take on and execute any other specific assignments delegated by Andrx management.
Lead the operational performance of a department or project and develop plans to achieve corporate strategy via departmental operations. Formulate annual and long-term goals for the department or function, and allocate resources to reach goals. Have wide latitude in modifying practices and procedures to complete work assignments and/or projects. Develop and adhere to departmental budgets. Serve as a mentor and coach; develop managerial and technical expertise of direct reports
Responsible for all employment and performance actions. Maintain external relationships (vendors, customers, etc.)
Attend inter/intra department meetings and effectively represent Product Development in project team(s). Keep abreast of technical, political and regulatory developments relating to product development.Job Requirements
Qualifications:
Bachelor’s in Pharmacy, Engineering, or science related field with 20+ years of related experience or combined education & experience; or
Master’s in Pharmacy, Engineering, or science related field with 18+ years of related experience or combined education & experience; orOther experience/degree required: Ph.D with 15+ years of experience + years of management experience is required.
Proven managerial and administrative ability including experience in supervising and managing scientific staff.
Proven track record of successfully developing and commercializing modified release products.
Thorough knowledge of cGMPs.
Good technical writing skills.
Ability to communicate clearly on technical matters.
Good communication skills and team player