Raleigh, NC, inhalation company. The Analytical Director will have responsibility for the strategic oversight of analytical operations including method development, validation and implementation, as well as analytical method transfers, and the support of regulatory submissions including INDs and NDAs. The Analytical Director will also manage contract analytical services.
Responsibilities
• Supervise and establish work assignments for a group of scientists as well as Project Leaders and Analysts
• Lead all analytical laboratory group activities (e.g. analytical method development and validation as well as managing routine testing) for assigned projects, including:
• Develop timelines, work plans, and milestones for the team
• Plan and schedule analytical method development, validation and transfers
• Support formulation development and manufacturing activities
• Author and/or review technical documents, including validation protocols and reports, analytical test procedures, technical reports and change controls
• Work with the database manager to assure the compilation of data and reports necessary to support decision making for product development and to support regulatory submissions
• Manage the transfer of analytical methods to CRO and CMO partners
• Provide training, technical expertise and support to staff
• Ensure GMP compliance where necessary
• Identify opportunities for quality enhancement and improvements to operational efficiencies and develop efficient methodologies to track progress.
Requirements
• PhD in analytical chemistry with 10+ years experience (or MS with 15+ years)
• Extensive experience in development and validation of HPLC methods
• Extensive knowledge of diverse analytical methods is desirable, especially aerosol testing
• Willingness to work with multiple teams at multiple sites
• Significant experience and comprehensive understanding of cGMP laboratory practices
• Familiarity with ICH and FDA guidances
• Ability to communicate effectively, make presentations and write concise reports for senior management and all levels of employees
• Travel of ~35% between the California and North Carolina research sites and contract facilities as necessary.
Physical Demands & Work Environment
Must be able to operate a PC and sit for extended periods of time. Some lifting required (not more than 50 lbs.). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. The order in which duties and responsibilities are listed is not significant.
For more information, contact Pam Gowda at pamgowda@kineticsearch.com
