Scientist II Process Development
3 weeks ago
We are seeking a highly skilled Scientist II Process Development to join our team at Iovance Biotherapeutics Inc. This individual will be responsible for in-house lentiviral process development, evaluation of lentiviral vectors, and collaboration with the analytical department to develop new lentiviral-related assays/methods.
Key Responsibilities- Function as the team's lentiviral subject matter expert, supporting lentiviral manufacturing and TIL transduction development, interfacing with external lentiviral manufacturing partners, and contributing to regulatory filings.
- Lead in-house lentiviral development activities, including production and evaluation of in-house produced lentiviral, evaluation of externally produced lentiviral, development of new methods, and cell line development.
- Design and execute development and characterization studies with a high degree of autonomy, writing protocols, analyzing data, authoring reports, and presenting findings.
- Assist teammates in managing external lentiviral manufacturing, guiding external development and manufacturing activities, and partnering with the analytical department on assay/method development.
- Support manufacturing investigations and ongoing process development activities as needed.
- A minimum of a bachelor's degree in chemical engineering, immunology, biology, microbiology, or a related scientific field, and 14+ years of industry experience, or a master's degree with 12+ years of industry experience, or a Ph.D. with 6-8 years of industry experience.
- Excellent working knowledge of lentivirus biology and production, with a deep understanding of factors affecting lentivirus quality, titer, and ability to transduce.
- Experience with flow cytometry to evaluate gene expression and other expression and/or titration methods.
- Strong technical writing and oral communication skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of autonomy.
- Experience with cell therapy products, especially CAR-T, is a plus.
- Experience with large-scale lentiviral manufacturing, either hands-on or managing external partners.
- Authoring sections of regulatory filings (IND/IMPD, amendments, BLA/MAA, IRs).
This position will work in both an office and a laboratory setting, with a risk of exposure to hazardous or biological waste within the environment.
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