Director of Analytical Development
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Job Profile Title
Director, Senior Research Support
Job Description Summary
The Director of Analytical Development will provide leadership for both internal and external efforts to develop and execute complex analytical methods for viral vector product release. Lead the technology transfer to facilitate method qualification and validation.
Lead biological development and lead both internal and external efforts to develop and execute complex analytical methods at contract Research/Development Organizations (CRO’s) for viral vector product release including potency, safety and product quality. Lead the technology transfer and of complex analytical methods to CROs and partner with QC to facilitate method qualification and validation. Manage efforts to internalize or outsource analytical capabilities as a key strategic component to drive vector production and development strategy into action by either internalize or outsource analytical methods to support client’s clinical and commercial development. Manage and direct internal analytical development efforts to refine, qualify, and implement basic viral vector analytical characterization and/or QC in-process and lot release methods.
Partner with Manufacturing and Quality functions (internal manufacturing QA/QC, Qualified Persons, and CRO Quality Organizations) to ensure effective SME support of technology transfer activities and CROs. Direct Analytical Development on documentation of external analytical method development efforts in CMC regulatory activities. The director will provide leadership and represent Pharmaceutical Development at cross functional CMC teams and/or Program Core Teams. Provide strategic CMC leadership and represent pharmaceutical development at cross-functional program team and CMC strategy meetings.
This position is contingent on funding.
Ph.D. or equivalent doctoral degree and 5 years of experience required.
Job Location - City, State
Department / School
Perelman School of Medicine
$32,000.00 - $204,000.00
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