We are seeking an experienced and motivated Scientist to join Drug Product and Analytical Development team with focus on cell therapy. The person will work closely with Contract Manufacturing and Testing Organizations to support the advancement of neo-antigen based personalized vaccines as well as T-cell therapy.
- Support activities such as analytical method development and related improvements by performing experiments whenever necessary.
- Product development, tech transfer and CMC activities
- Participate in technical and scientific interactions with Contract Testing and Manufacturing Organizations.
- Review and analyze analytical data to help in making key decisions regarding lot release or stability while closely working with Quality.
- Perform data trending of stability data and process monitoring of lots produced under GMP.
- Work with QA to facilitate resolution of CMO quality issues (e.g. Deviations, Change Controls etc.)
- Support qualification of drug substance and drug product test methods, QC release and stability testing.
- Collaborate efficiently and effectively across other Pharm Sci & Manfacturing groups as well as research team to advance CMC activities.
- Author regulatory documents (e.g. IND) and support in discussions with regulatory agencies.
Education and Experience Required:
- D. in Life Sciences with relevant industry experience or MS with 4+ years of experience in analytical development
- Knowledge of cGMPs.
- Hands on experience with various cell-based assays, flow cytometry and ELISA.
- Experience with compendial methods for biologics or cell and gene therapy.
- Mass spectrometry experience especially in LC-MS/MS for biologics is good to have but not must.
- Knowledge of Immunology (T cell biology)
- Characterization of cell therapy-based products
- Vaccines development