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Hydrogen Group - San Diego, CA
posted 2 months ago
Full-time
San Diego, CA
Administrative and Support Services
About the position
The Assay Tech Transfer Scientist will be responsible for designing, optimizing, validating, and initiating tech transfer documentation for critical assays required for regulatory approval in the pharmaceutical industry. This role emphasizes the application of assay development expertise and compliance with GLP and cGMP standards to create advanced quantification methods for product release.
Responsibilities
- Design and optimize assays for identity, purity, and potency necessary for regulatory approval.
- Validate and initiate tech transfer documentation for critical assays.
- Apply assay development experience to generate state-of-the-art quantification methods.
- Support pipeline product development and generate new intellectual property.
- Optimize processes for scaled-up manufacturing of 2-D and 3-D cell culture methods.
Requirements
- Years of experience in assay development in a pharmaceutical setting.
- Familiarity with GLP and cGMP compliant methods and documentation practices.
- Experience with quantification methods such as Nanoparticle Tracking Analysis and quantitative PCR.
Nice-to-haves
- Experience with proteomics and miRNA-omics techniques.
- Knowledge of D-storm microscopy.
