Scientist - QC Biologics
Edison-New Brunswick Metro Area, NJ
Education and Experience
Bachelor s Degree required, preferably in Science.
2+ years of relevant work experience, in FDA / GMP regulated environment
Ability to follow and apply Global Regulatory and cGMP requirements.
Ability to author technical documents using QC templates.
Knowledge of analytical techniques such as HPLC, GC, FTIR, Osmolarity and pH
- Responsible for supporting the testing and release of incoming materials used in CAR-T manufacturing during clinical and commercial phases.
- Additionally, when needed, provide support with the authoring of technical documentation for QC Incoming.
- Assist document revision, project, CAPA, and investigation/deviation tasks.
- Assist in drafting technical documents, such as SOPs and protocols/reports.