Associate Director, Analytical Development (Sterile Products, Small Molecul Not right for you? We've got others

Irvine, CA
December 7th 2018
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Position Overview
Provide analytical expertise and leadership in the development of drug substances and pharmaceutical products from early development through commercialization.  Plan analytical research and development activities, devise strategies for achieving project goals and independently manage CMC timelines.  Make pivotal contributions to drug product development strategy at project team level.  Independently manage multiple projects and ensure timely delivery of all deliverables to meet project milestones and goals.  Originate novel approaches to solve experimental problems and generate novel experimental protocols.  Design, manage, lead, and implement analytical development activities to support all stages of drug development, including drug substance and drug product development.  Supervise, mentor and direct the work of assigned staff.  Oversee and coordinate analytical development activities in-house and at contract labs and ensure quality and timeliness of work.  Provide leadership, direction and analytical support for investigations and troubleshooting analytical issues.  Design stability studies to support shelf life and storage statements for drug substance and drug products.  Propose and justify specifications for drug substance and drug product.  Review and approve analytical data, technical protocols/reports and analytical methods in support of regulatory CMC filings.  Author and review relevant sections of IND's and NDA's and prepare responses to CMC questions from regulatory agencies.  Identify, evaluate, recommend, and purchase new equipment to meet project needs.  Develop, review, and approve standard operating procedures to satisfy cGMP and corporate requirements.  Collaborate with cross-functional groups to meet drug development milestones.  Lead CMC Teams as required.  Lead and/or contribute to various departmental and cross-functional teams as assigned.  Keep current in analytical research including literature and technology advancement.  Investigate new technology and research opportunities.  Publish and give presentations at both internal and external meetings.  Provide training and coaching to staff for their career development.  Contribute to department and lab management strategies and activities.
Main Areas of Responsibilities 
The following listed requirements need to be met at a minimum level to be considered for the job:Preferred Skills
The below skills are attributes that may not be mandatory but are strongly desired in the ideal candidate: Education


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