Associate Director/Director, Analytical Sciences, Pharmaceutical Development

Eagle Pharmaceuticals Cambridge , MA 02138

Posted 2 months ago

Overview

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include RYANODEX, BENDEKA, BELRAPZO, and its oncology and critical care CNS/metabolic pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle's website at www.eagleus.com.

Responsibilities

  • Manage day-to-day analytical activities including timeline, budget management, objective setting and internal lab operations.

  • As the technical expert, design detailed and phase appropriate work plans and execute the plans through internal resources as well as partnership with our CDMOs.

  • Lead phase appropriate analytical method development and validation from preclinical through commercialization in compliance with ICH and related guidance.

  • Lead development activities such as stability studies, compatibility studies, establishment of phase-appropriate specifications and control strategies for starting materials, intermediates, drug substance, excipients and drug product in compliance with ICH and related guidance.

  • Lead the characterization of process- and product- related impurities as well as product structure.

  • Provide technical support for laboratory investigations, deviation investigation and review of investigation reports.

  • Author and review analytical documents including study protocols, reports, SOPs, and CMC sections/responses in regulatory submissions or questions.

  • Collaborate effectively with internal and external key stakeholders to deliver program goals.

Qualifications

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  • Requires an MS or PhD in analytical chemistry, organic chemistry, or related field with 10+ years' experience in analytical development in the pharmaceutical industry.

  • Demonstrate leadership skills, planning and organizational capabilities. Effectively implement work plans cross-functionally.

  • Proven ability to manage projects and work with cross-functional teams comprised of internal groups and external CMOs.

  • Hands-on experience as well as knowledge of analytical testing concepts and cGMPs including laboratory controls and good documentation practices across development stages from pre-IND to NDA.

  • Demonstrated ability to build and maintain positive and collaborative relationships with management, peers and CMOs.

  • Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.

  • Excellent oral and written communication skills.

  • Ability to work independently, or under minimal supervision to handle workflow in a multi-tasking environment.

  • Ability to work flexibly to accommodate program priorities, international activities, and travel as needed.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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Associate Director/Director, Analytical Sciences, Pharmaceutical Development

Eagle Pharmaceuticals