Provide technical expertise in developing Bioanalytics testing solutions in support of clinical and commercial manufacturing’
Job Description: (Several Sentences, possibly bullets)
- Drive the assay technology innovations across different platforms and different phases of manufacturing processes.
- Design and execution of phase-appropriate analytical strategies including analytical method development, specifications setting up, reference standard characterization, TM validation, procedures developments.
- Establishment of test methods for MCB/WCB, vector and viral product characterization and process SQIPE QC to enable process QC and product batch release, formulation development, comparability assessments and stability programs for gene therapy products from the early development stage to commercialization.
- Doctoral (Ph.D.) degree in relevant Science with 4 or more years of industrial AD experience, or MS, BS with equivalent experience.
- Previous experience with gene/cell therapy products or viral product is highly recommended.
- Experience with analytical development of cell/gene therapy in various stages of development (preclinical to commercialization).
Phone: 860-278-5840 ext 245