Location	Cork
Salary	Competitive
Ref. No.	TSPBFAy
Duration	Permanent
Division	Quality & Laboratory

Description

Reporting to the Technical Services Leader the primary role of the Technical Services Professional is to conduct laboratory pre-qualification (LPQ) experiments to test process robustness for monoclonal antibody production processes.  The successful candidate for this role will be required to complete training in Sandwich for a period of months.

 

Main areas of responsibility:

•         Complete laboratory process robustness studies on downstream processes utilized in the manufacture of monoclonal antibodies.. 

•         Generation and demonstration of scale-down model for monoclonal antibody downstream processes;

•         Conducting laboratory robustness experiments for a monoclonal antibody downstream process,

•         Generation of formal documentation for LPQ studies;

•         Production of intermediate process samples for use in LPQ studies, if required;

•         Participation in DSP tech transfer activities to clinical manufacturing and other Pfizer manufacturing sites;

•         Conducting development experiments for second-generation monoclonal antibody production processes;

•         Participate in technical troubleshooting for clinical manufacturing

•         Maintenance and oversight of technical services laboratory.

 

Knowledge or Experience Required:

 

•         Bachelor degree in chemistry, biotechnology, biochemistry or chemical or bio-systems engineering or related sciences or equivalent experience.

•         A demonstrated commitment to safety.

•         Strong verbal, written and interpersonal communication skills.

•         The ability to work effectively in a team environment and to interact successfully across divisional boundaries.

 

The following would be advantageous but are not required:

•         Laboratory experience working with chromatography and filtration processes in production development.

•         Excellent knowledge of cGMP's/FDA requirements.

•         Knowledge and experience with process validation and process scale-down.

•         Familiarity with protein characterization analytical techniques.

•         Familiarity with statistical experimental design methods.

•         Experience in supporting the scale-up and technology transfer to pilot/commercial scale.

•         Previous experience with the execution and documentation of laboratory pre-qualification studies.

 

Contact Brian Flynn at 021 4509200 or e-mail brian@fastnetrecruitment.com