- Exhibit strong interpersonal and technical skills working in a team that is engaged in novel method development in AAV Gene Therapy.
- Manage the development and transfer of methods to the quality control group or external testing labs.
- Interact with AD, QC, and QA to assess the competency of the current assays and the need for continuous improvement of methods.
- Collaborate with CMC teams to develop the timelines for validation of assays and transfer to QC.
- Manage the process to set up suppliers for specialized reagents.
- Assist in 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.
- Author development reports, qualification protocols and qualification reports
- Ph.D. degree in Virology, Molecular Biology or related field with 8+ years relevant industry experience or a Master's degree in Virology, Molecular Biology or related field with 10+ 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, qPCR, ddPCR, ELISA, SDS-PAGE, in-vitro 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 will be additional qualification.
- 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. #LI-Onsite
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Associate Director, Gene Therapy Analytical Development - Andover, United States - Sarepta Therapeutics
Description
This individual will join the Analytical Development team involved in the development of novel AAV Gene Therapy analytical methods. The individual will have an in-depth knowledge of AAV gene therapy analytical methods that include qPCR, ddPCR, TCID50, rcAAV, SDS-PAGE, CE, ELISA, AUC, FACS and potency (in vivo and in vitro). The Associate Director should have demonstrable skills of managing milestone based AAV gene Therapy product development leading into method validation and transfer to QC for performing routine analysis. They will manage the steps from conception, reduction to practice, development and planning for the qualification/validation of the assay methods. They will work collaboratively with the Quality Control department to transfer the assays to QC or to a laboratory that would validate the method. The individual will assist in troubleshooting assays both internally and external sites, improving existing assays to be more reproducible and robust.Primary Responsibilities Include:
Desired Education and Skills:
This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
