Manufacturing Associate

As part of a team working to develop mammalian cell culture processes, the Manufacturing Associate will be responsible for cell culture production in 50 L and 250 L scale disposable bioreactors of pre-clinical and clinical products for recombinant proteins and monoclonal antibodies utilizing CHO cells in a GMP Manufacturing pilot plant facility.

 

Responsibilities include:

Assist or perform and document routine procedures following written instructions (SOP’s, batch records, solution documents, protocols, etc.) in support of manufacturing pre clinical and clinical material in compliance with regulatory guidelines

Maintain, prepare and clean manufacturing areas, equipment, lab-ware and materials

Prepare solutions, media and other process related items in support of manufacturing processes

Collect in-process samples for pH, conductivity and temperature, etc. in support of manufacturing processes

Operate manual, semi-automated and automated equipment used for the production of biopharmaceuticals in cell culture and harvesting

Support in the commissioning/start-up and validation of process equipment and Engineering runs

Troubleshoot equipment and manufacturing processes

Assist in the investigation of environmental excursions and deviations

Coordinate product changeover

Write and revise SOPs, Master Batch Records and other manufacturing documentation

May assist in review of GMP documentation

Assist in training others in routine procedures

 

Qualifications:

Candidate will have a B.S. in Biology or related field and at least 3 years of experience working in a cGMP environment

Availability to work a 24/7 schedule when operation is implemented

Solid experience in mammalian cell culture and aseptic technique

Working knowledge of using wave bags

Knowledge of purification would be a plus

The position is full-time at AVANT’s Fall River pilot plant facility