Development Engineer II

Development Engineer / Associate (Contract) – Clinical Drug Product Manufacturing Sciences (CDPMS) 

The Development Engineer / Associate – CDPMS will assist drug product tech transfer teams with project management support. Project management support will include scheduling, resource planning, and project task tracking. A candidate with the right experience would have the opportunity to lead a drug product tech transfer team. The primary responsibility of the candidate will be to perform project management activities to manage the external manufacture of clinical trial materials. In addition, the candidate will coordinate external research projects such as compatibility and filter validation studies. Additional responsibilities will include performing drug product process development studies in collaboration with drug product manufacturing and formulation development teams. The Development Engineer / Associate will also analyze experimental data, document results and conclusions in technical reports, and assist Senior Staff with drug product tech transfer management projects. 

This will be a visible and hands on role with opportunities to contribute to multiple clinical stage programs. In this role, the Development Engineer / Associate must be able to work independently and be self-motivated. The candidate must manage time efficiently to balance multiple projects and priorities. Excellent organization and communication (oral and written) skills are required. 

Qualifications 

• BS/MS in degree in chemical, biochemical, biomedical engineering, chemistry or related field 

• 3-6 years industry experience in formulation and/or drug product process development 

• Experience in supporting tech transfer projects to contract research and/or manufacturing organizations 

• Project management experience including time and resource scheduling 

• Experience in a GMP environment or GLP laboratory is preferred 

• Experience with Microsoft Project, Vizio, and advanced Excel spreadsheets is preferred 

• Experience managing outsourced research projects is a plus 

• Knowledge of statistical design of experiments is a plus