Process Development Scientist (Chemical Development) - Pharma API Development and Manufacturing –Raleigh Pharma/ Will Relo

Job Type: 
Life Sciences
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, an Raleigh area pharmaceutical company in high growth mode, is actively recruiting for a very sharp and capable Chemical Engineer to join its Manufacturing team.

This company has multiple products in development.  These are combination products and this Engineer will be providing chemical development support for all API development and manufacturing activities. 

This is a key role and company will relocate to attract a star.

Selected Responsibilities:

ü  Design and conduct chemical experiments for the development of robust manufacturing processes. 

ü  Experimental approaches may include:

o   reaction profiling

o   statistical analysis

o   process and impurity fate mapping with spiking & purging

o   process robustness studies

o   generation of solubility curves

o   development of controlled crystallization, isolation and drying processes. 

ü  Evaluate synthetic routes to support commercial route selection, including feasibility studies (scouting) and reaction screening/profiling.

ü  Demonstrate manufacturing processes using equipment that mimics larger-scale manufacture.

ü  Write manufacturing process instructions and provide manufacturing process development data to support regulatory submissions.

ü  Assist with technology transfers, process development, risk assessments (e.g. FMEAs), optimization, qualification and validation of API manufacturing operations.

ü  Provide support for chemical process activities at contract research and manufacturing vendors involved in the manufacture of starting materials, key raw materials and APIs. 

ü  Execute laboratory IQ/OQ activities where needed.

ü  Maintain high quality laboratory records.  Summarize results in well-written reports and presentations.

Targeted candidate will offer a BA/BS in chemical engineering (or related) and 2+ years of directly-related experience in industry.  Strong bkgd working in the lab will be important.

Other priorities include:

ü  Experience in small molecule chemical process development and crystallization

ü  Familiarity with design of experiments (DoE) and statistical analysis

ü  Demonstrated knowledge of the expectations in a cGMP-regulated setting

ü  Strong documentation skills

ü  Meticulous work habits

ü  Longevity and growth in previous roles 

Finally, we seek an industrious and self-directed team player who will work well within a collaborative setting, stay focused on the goal despite disruption and/or change and will enjoy the high-paced, dynamic work culture.

This is an immediate need.  Please forward Word resume for prompt consideration.