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Assistant/Associate Director, Downstream Process Development

Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies across a wide variety of indications.?? AGTC is seeking a highly motivated individual who will be responsible for developing robust, well-defined, downstream processing platforms for rAAV and rHSV vectors that are GMP ready.?? He/She will work closely with the Executive Director, Process Development to develop strategic objectives, both for internal projects and external collaborations, and to manage the resources required to meet those goals.?? Title will be commensurate with degree and experience.
Reporting Relationship
The Assistant/Associate Director, Downstream Process Development will report directly to the Executive Director, Process Development
The position will be located in Alachua FL.
Essential Duties and Responsibilities
Manage a team at the Alachua site, including hiring, training, career and goal development and assessment.
Lead comprehensive development activities for viral vector processing platforms, including dead-end filtration, chromatography and UF/DF unit operations.
Serve as the Downstream process development subject matter expert for technology transfer and collaborations.
Identify, test and implement, as appropriate, new technologies for process improvement and increased robustness of vector processing platforms.
Represent the company, report results at relevant meetings and submit manuscripts for publication.
Work closely with AGTC QA and Regulatory functions to develop and comply with internal standards and regulatory authority expectations in all aspects of GMP-focused processes.
Qualifications
MS with eight (or PhD with five) years of experience in Engineering, Biotechnology, Biology or similar discipline.
Experience, Knowledge, Skills and Abilities
Demonstrable track record at solving complex processing challenges in the context of biopharmaceutical drug development.?? Prior experience in viral process development and purification strongly preferred.
Working knowledge of QbD, DOE and/or PAT
Superlative communication and presentation skills.
Experience working within a regulated environment and a working knowledge of GMP regulations
Previous management or supervisory experience required
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity.?? AGTC is an EOE and maintains a drug free workplace.?? Please send CV or resume.
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