Process Engineer III, Manufacturing Sciences & Technology

to generate, manage, evaluate, and maintain critical data in a highly organized manner

Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)

3-6 (BS) or 1-4 (MS) years of relevant experience in gene therapy or other biotechnology industry

Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing preferable in the area of viral vaccines or gene therapy

Experience with technology transfer and GMP manufacturing technical support is preferred

Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems

The annual salary range for this position is $105,000-$130,000.

GENEZEN'S

CURES

VALUE-BASED COMPETENCIES

C

ommitted to Science

The MSAT group plays a critical role in successful manufacturing of clinical and commercial products.

The person in this role assists in the transfer of technologies, process validation and cGMP manufacturing of products.

This individual will contribute as a core member of various cross-functional teams, and interacts extensively with other departments within Genezen, including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affair etc..

Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time troubleshooting (i.e.

chromatography, filtration, TFF, buffer generation, drug product filling)

Assist technology transfer to GMP manufacturing by reviewing process description documents, technology transfer reports, reviewing master batch records, and providing on-floor support for transfer operations