<p>Arrowhead is seeking a Director of Analytical Development to join the Process & Analytical Research and Development and Manufacturing team as the Director of Analytical Development. The successful candidate will be tasked with hands-on development of robust analytical methods for both large and small molecule drug candidates to support ongoing product and process development activities in addition to providing necessary guidance to other team members. S/He will be expected to: </p> <ul> <li>Work closely with drug substance and product development teams to determine analytical requirements and develop required analytical methods.</li> <li>Communicate and collaborate where necessary with Arrowhead preferred contract manufacturing organizations.</li> <li>Form strategy and draft analytical portions of regulatory documents</li> <li>Interact effectively with Arrowhead cross-functional teams to ensure timely delivery of robust methods.</li> <li>Track progress against project plans, generate regular status updates, and communicate progress and issues to management </li> <li>Supervise research of direct reports. </li> <li>Qualifications</li> </ul> <p>Required:</p> <ul> <li>PhD degree in analytical chemistry with at least 8 years of progressively responsible experience (MS degree with at least 15 years of experience) in pharmaceutical or biotech industry. </li> <li>Extensive HPLC and mass spec experience covering a range of separation and detection types is required. </li> <li>Previous experience in GMP manufacture and release is required.</li> <li>Experience in writing the analytical portion within the CMC section of worldwide regulatory documents is required. </li> </ul> <p>Preferred:</p> <ul> <li>Extensive experience in analytical development for both small molecule and large molecule drug candidates in the pharmaceutical industry. </li> <li>Demonstrated track record in problem solving. </li> <li>Experience with a wide range of analytical techniques. </li> <li>Deep understanding of the drug development process and governing regulations. </li> <li>Experience interacting with regulatory agencies on analytical issues within the CMC section of worldwide regulatory documents. </li> </ul>
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