A global biotechnology company on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short.
This Jobot Job is hosted by: Avery Warwick
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Salary: $200,000 - $260,000 per year
A bit about us:
A global biotechnology company on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.
Why join us?
This individual manages a AAV Gene Therapy analytical method development group engaged in the development of cutting-edge analytical methods. The individual will have an in-depth knowledge of AAV gene therapy analytical methods that include qPCR, ddPCR, TCID-50, rcAAV, NGS and Sanger sequencing, SDS-PAGE, CE, ELISA, AUC and potency (in vivo and in vitro). The individual should have demonstrable management skills of managing 20-30 personnel engaged in developing methods for release and characterization of AAV gene Therapy products or other viral therapies for clinical use. The individual will manage the development of the assays and qualification of the assay methods.
Primary Responsibilities Include
Exhibit strong leadership and managerial skills, supervise a group of up to 30 Gene Therapy AD Analysts
Interact with the Quality Departments (QA and QC) to assess the need for improved methods and new methods.
Develop, qualify, and transfer methods to the quality control group or external testing labs.
When constrained by instrumentation or lack of personnel, develop novel methods with collaboration at contract laboratories.
Set up suppliers for specialized reagents.
Serves as subject matter expert on the stage appropriate validation of test methods for clinical products intended for early to late stage clinical trials
Draft early stage methods and convert them to SOP for easy transfer to QC.
Improve the level of assay automation in the laboratories to meet the throughput needs.
Author development reports, qualification protocols and qualification reports
Desired Skills And Education
Ph.D. degree in Virology, Molecular Biology or related field with 12+ years relevant industry experience or a Master's degree in Virology, Molecular Biology or related field with 15+ years relevant industry experience.
A strong understanding of contemporary molecular biology methods with hands on experience in managing a high-performance laboratory operation.
A demonstrable grasp of a wide range of technologies TCID50 test methods, qPCR, ddPCR, ELISA, SDS-PAGE, in-vivo potency as applied to gene therapy products is required.
Working in a cGMP environment engaged in release of a biologic and experience in writing regulatory documents required
Must have effective written and verbal communication skills
Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.
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