- Conduct laboratory experiments involving in vitro potency methods in support of release and stability testing of AAV based gene therapy products.
- Prepare, qualify, and release standards for the in vitro potency methods.
- Test new cell lines for use in new potency assays.
- Maintain cell banks in cryogenic storage.
- Create and maintain clear and concise lab records and documentation.
- Author test methods, development reports, study protocols, and validation reports.
- Independently define and execute experiments as well as suggest improvements and solutions to address new problems as they arise.
- Support the method development, transfer and qualification/validation activities associated with the release of viral vector products.
- Assist in writing and reviewing quality documents such as SOPs and technical reports.
- Author test methods, development reports, study protocols, and validation reports.
- Perform other related duties incidental to the work described.
- B.S. or M.S. degree in molecular biology, cell biology or virology with at least 2-5 years relevant experience.
- Working experience in a cGMP environment is preferred.
- A strong understanding of cell culture methods, capillary based immune-assays, and cell banking is necessary.
- Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.
- Experience in developing, validating, and deploying molecular biology test methods is useful.
- Experience with reading and synthesizing primary literature is useful.
- Must have effective written and verbal communication skills, including presentation 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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Research Associate II, Gene Therapy Analytical Development - Andover, United States - Sarepta Therapeutics
Description
This individual will support analytical development activities conducted at Sarepta Andover facility in the field of in vitro potency of AAV based Drug products. The individual will help in the development and validation of cell-based in vitro potency assays. The position requires a strong background in cell culture, sample preparation and protein analysis. The work involves performing assays in a BSL-2 environment. The individual will be responsible for conducting experiments, reviewing in vitro potency data, writing technical reports, supporting analytical method validation and qualification activities. The individual will also assist in managing the instrument validation and qualification. All aspects of this position would involve working in a GMP compliant manner.
Primary Responsibilities Include:
This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $68,000 - $85,000 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.
