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Director, QC Analytical
Full Time
Philadelphia, Pennsylvania, United States (This job is on-site)
Job description
Scismic is supporting the growth of a Contract Development and Manufacturing Organization (CDMO) specializing in the innovative and rapidly evolving field of cell and gene therapy.
Responsibilities:
Responsibilities:
- Supporting and building out a team of scientists conducting analytical development, quality control and assay technical transfer (molecular team, biochemical team, bioassay team, physical/chemical team and quality control (QC) team.
- Authoring and reviewing development and technical reports, SOPs and test records, study reports, qualification reports, relevant sections of regulatory submissions and participate in the establishment of electronic information systems.
- Overseeing QC functions, including QC testing, analytical testing, and stability programs.
- Oversee the development, conduct and qualification as necessary of assays to evaluate viral vector drug substance and drug product concentration purity, identity and infectivity.
- Oversee the conduct of analytical studies such as biodistribution and shedding and testing for stability studies. Analytical testing may be conducted as research testing or as GLP/GMP testing with Quality Assurance oversight.
Requirements:
- BS/MS/PhD.
- 10+ years of experience.
- Working knowledge of methods and assays such as ddPCR, qPCR, ELISA, TCID50, and RCAAV in order to oversee development and testing activities as well as ensure appropriate training and documentation (technical reports, test records).
- Fundamental understanding of GMP and GDP, and analytical.
- Strong technical writing skills.
- Must have expertise in molecular and/or biochemical and/or cell-based assays for the characterization of biological products.
- Must have a thorough understanding of GxP and of CMC regulatory guidances for the manufacturing and testing of gene therapy products.