Our Immuno-Oncology client just north of Boston, MA is looking to add an Analytical Development Specialist to their team! Analytical Development Specialist is responsible for supporting the analytical method development and coordinating analytical vendors for the company’s gene therapy programs. Other responsibilities include but not limited to:
- Manage and organize CTL/CDMO activities and schedules associated with gene therapy analytical development and testing.
- Review analytical plans, method design and test method data generated by CTL/CMOs and where applicable write summary reports.
- Perform data analysis and trending for analytical test methods.
- Design and plan analytical technical and operational details with CTL/CMOs to support analytical development and technology transfer for vector gene therapy programs.
- Inform and support execution of CMC analytical methods and testing decisions, including component and raw material specifications, drug substance and drug product specifications, DS and DP in-process specifications, virus and cell bank testing, analytical methods, product characterizations, comparability studies, stability programs, release testing procedures, SOPs and other controls for each of the Company’s products.
- Facilitate and coordinate operational logistics associated with analytical samples, analytical raw materials, and shipping as applicable.
- Assist in reviewing analytical content of Quality Systems documents ( testing data, batch records, SOPs, deviations, validation reports, etc.).
- Assist in reviewing and organizing proposals quotes, contracts, and invoice from vendors.
- Participate in CTL/CMO selection for analytical method development and testing.
- Contribute to CMC analytical sections for submission to regulatory agencies.
- MS/BS in a biology or biochemistry field 3+ years of biotechnology industry experience (gene/cell therapy preferred). Experience in working with CTL/ CMOs preferred.
- Knowledge of analytical development and analytical testing, cell and immune based assays, product characterization, cGMP, drug development.
- Knowledge of viral based biologics.
- Knowledge of statistics.
- Trouble shooting and problem-solving skills.