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Job #03037

About our client Our client is the research and development division of a world-leading technology company that has developed a reputation for successfully bringing innovative drug delivery products to market. The company has an experienced management team, a stable history and a strong track record with the FDA. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Director, Analytical Research and Development Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist with the daily operations of the AR&D Department 2) Manage a major project or program within the department 3) Direct functional group(s) including method development/validation/transfer, support formulation 4) Develop product, operate commitments (release of API and product), investigate aberrant data, improve projects on a continuous basis, work on compliance initiatives and hire within the group 5) Lead the analytical activities related to API sourcing, pre-formulation/formulation, products development, stability evaluation, etc. for both NDA and ANDA 6) Evaluate capacity of the functional group and make commitments for completing specific projects and/or sample analysis 7) Lead, supervise, coordinate method development, method validation and method transfer to quality control and contract laboratories 8) Provide information cross functionally to other departments 9) Involve in hiring, training and evaluating performance 10) Ensure productivity of all direct reports 11) Prepare, review and approve STPs, SOPs, protocols and technical reports as needed 12) Provide directions and mentorship for direct reports 13) Follow cGMP, SOPs and safety regulations all the time 14) Prepare, submit and manage the annual budget for the AR&D Department Requirements 1) MS with 15+ years of related experience in ARD or research environment or Ph. D. with 10+ years of related experience in ARD or research environment with first authored publication(s) 2) Minimum of 8 years of progressive experience with at least 5 years at a management level 3) Knowledge of SOPs, USP/FDA/ICH regulations, analytical testing techniques, cGMP, and OSHA regulations/procedures for disposal of organic waste and procedures for the safe handling of chemicals 4) Good interpersonal, organizational, communication, time-management and multi-tasking skills 5) Superb computer skills – Microsoft Word, Excel, PowerPoint and Lotus Notes 6) Ability to build and maintain trust with staff and other management