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Senior Director, Analytical Qualification & Technical Transfer (Gene Therapy Program)
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Posted Job Title
Senior Director, Analytical Qualification & Technical Transfer (Gene Therapy Program)
Job Profile Title
Director D
Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the “go-to” organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Continuation of all GTP positions is contingent upon funding.
Job Description
Our Vector Operations group, comprised of Manufacturing Sciences and Technology (MS&T), Analytical Sciences and Technology (AS&T) and External Manufacturing (EM) teams, provides manufacturing and analytical support of basic, translational and clinical research. The MS&T team is composed of teams that conduct platform development, process development and optimization, vector manufacturing and process technical transfer. The AS&T team conducts analytical development and qualification, testing, and assay technical transfer. The AS&T organization includes a molecular team, biochemical team, bioassay team and physical/chemical team as well as a Quality Control (QC) team. The analytical development teams (molecular, biochemical, bioassay and physical/chemical teams) develop, quality and conduct testing (research or GxP). The QC team currently oversees QC operations team including scheduling, stability programs, sample management and out-sourced testing and will expand to include QC testing for assays internally tech transferred from the analytical development teams.
Due to the continued growth of the Gene Therapy Program , we are seeking a Senior Director of Assay Qualification and Technical Transfer. The role of the Senior Director will be to establish a new team to support analytical testing and technical transfer both within and external to the organization. As Senior Director, you will oversee the establishment of method qualification procedures and the authoring of standard operating procedures applicable across the analytics organization. You will oversee the establishment of training policies and procedures and work closely with analytical leaders and QA on implementation. You will also oversee the technical transfer of analytics from assay development to internal QC teams as well as from GTP to external partners and CDMOs. You will work closely with Regulatory and Reg CMC to incorporate regulatory feedback into the analytics organization.
You will be expected to demonstrate a thorough understanding GxP including good documentation practices (GDP), good laboratory practices (GLP) and good manufacturing practices (GMP) as well as an understanding of regulatory guidances and requirements.
You will work both independently and as part of a team to accomplish project goals within specified timelines, workplans and budgets. Successful candidates will have experience building a QC unit, managing staff and managing multiple projects simultaneously. Importantly, successful candidates will have a strong understanding of GxP and regulatory guidelines as well as excellent written and oral communication skills.
Qualifications:
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