Our client, a biotech manufacturer is seeking a hands-on Biologist/Scientist for the daily supervision of GMP manufacturing operations in the Cell Culture and Bioreactor groups of Manufacturing.  Assist or implement new manufacturing and documentation.  Assure adequate training of all employees in compliance with GLP, GMP, and safety regulations in each lab.

§       Coordinate the operation of the bioreactors and propagation of inoculum trains

§       Coordinate required testing on all cultures to ensure consistent morphology and sufficient production levels will be maintained.

§       Coordinate all in-process testing and characterization requirements (ELISA, Growth Curves, Mycoplasma, Sterility, etc.). 

§       Perform all process scale-up and optimization to improved product yield and reduced costs within GMP compliance.

§       Prepare technical reports, validation protocols, production plans and monthly reports, Create/modify SOPs and documentation in accordance with cGMP

§       Ensure that routine equipment maintenance, cleaning & calibration

§       Ensure that personnel are operating under cGMPs, cGLPs, adhering to SOPs, Safety Procedures and Hazardous and Medical Waste Procedures.

§       Provide support and represent department during FDA/Client audits.

Requirements:

R    BA/BS in Biological Science or Related Field.

R    5+ pharmaceutical/diagnostic product cGMP manufacturing experience including at least a year of management

R    Detailed operating knowledge of pharmaceutical process engineering, cell culture, and bioreactor operation

Interested? Email your resume to Jennifer@mriweston.com