Process Development Engineer II/III

This individual will develop early phase drug substance manufacturing processes, transfer unit operations and processes from research and development to cGMP clinical production, and assist in the production of Clinical Trail Materials.

In this role the individual will study development processes; specify, qualify, maintain and improve process equipment; write or approve SOPs, Batch Records, development protocols, and technical reports; and plan and order materials for clinical manufacturing campaigns.

This individual will also maintain a database of development experiments and investigate unexpected experimental or process outcomes.

 

Minimum Education & Experience Requirements:

Bachelor?s degree in Chemical Engineering with 2+ years experience in pharmaceutical, fine chemical or medical device development or manufacturing.

 

Knowledge/Skills Needed:

The ideal candidate will have demonstrated proficiency in: Experimental design and interpretation of results, experimental and industrial statistics, excellent verbal and written communication skills, able to derive process development objectives with from product profile and overall project plan requirements.

It is preferred that the candidate will have the following additional skills: Experience in spray drying, continuous processing, or statistical process control, experience in pharmaceutical industry or knowledge of GLP and GMP requirements, Project Management experience (e.g. capital or development project), experience in root cause analysis.

 

Personal Attributes Needed:

Mechanically inclined and hands-on, Able to work independently and as part of an intra- and inter-departmental team and detail oriented.