Thousand Oaks, California | Contract
- Provide technical support for commercial drug product manufacturing at contract manufacturing sites.
- Perform characterization, monitoring, optimization, and troubleshooting of formulation, filling, and finishing processes for protein based parenteral products.
- Perform entry, verification, and analysis of process data.
- Generate technical reports and assessments.
- Provide support for non-conformances and other investigations, as well as CAPA and change control assessments.
- Support projects to advance technical maturity in contract manufacturing drug product unit operations (formulation, fill/finish, terminal sterilization, lyophilization, inspection, labeling/packaging).
Qualifications and Skills:
- Bachelor's or Master's in Engineering, Biology, Chemistry, or related discipline.
- Manufacturing, pilot plant, and/or laboratory experience with drug product processes and equipment.