Development Engineer II

Client: Direct Client

Location: Lexington, MA

Job Title: Development Engineer II

Duration: 1 Year + (Possible Extension)

Qualifications:

As a member of the Manufacturing Science & Technology group in Process Development department, this individual will join a group of process scientist and engineers to support downstream processes of commercial productions and late stage clinical process development and productions. The scope of work will include designing studies under instruction, executing experiments and data analysis to support GMP investigations and manufacturing change controls and to reduce reoccurring deviations. The focus of the work will be downstream unit operations such as column chromatography, harvest clarification, TFF and normal flow filtration. This individual will interact with other PD groups and other departments including manufacturing, PTS, QC, QA and Engineering etc. 

Job Functions 

• Design studies under management instruction, execute experiments and perform data analysis, and to continuously improve the process and to reduce reoccurring deviations 

• Under supervision, support root cause analysis during GMP investigations, and provide technical assessments for deviations and Change Controls 

• Write study proposals, research and development reports, and various technical memos 

• Evaluate new technologies under instructions to improve the commercial production process 

• Provide technical and scientific training to manufacturing supervisors and technicians