Location	Cork
Salary	Competitive
Ref. No.	PTLBFy
Duration	Permanent
Division	Executive Management

Description

Purification Lead - Technical Services

 

Pfizer plans to set up a new Bio Facility at our Shanbally site in Cork, Ireland. The investment will be in a small scale facility (SSF) with capability to support phase III clinical programs and small scale commercial products. This facility will employ over 100 people initially.

 

Reporting to the Technical Services Leader, the primary role of the Purification Lead is to lead 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 16 months followed by training in St. Louis for a further 2 months.

 

Main areas of responsibility:

•         Lead the Tech Services team in laboratory process robustness studies on purification processes utilized in the manufacture of monoclonal antibodies. 

•         Lead efforts to develop scale-down models for monoclonal antibody purification processes;

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

•         Generation of formal documentation for LPQ studies;

•         Co-lead downstream tech transfer activities to clinical manufacturing and other Pfizer manufacturing sites;

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

•         Lead technical troubleshooting efforts for clinical manufacturing

•         Work closely with PGRD, QC and Manufacturing personnel to ensure timely tech transfers into Manufacturing

 

Knowledge or Experience Required:

•         Bachelor degree in biotechnology, biochemistry or biosystems engineering or related field or equivalent experience.

•         Laboratory experience working with purification processes in production development including hands on experience in chromatography, centrifugation and filtration.

•         Good communications and ability to interact across divisional boundaries.

•         Ability to train members of Tech Services group.

The following would be advantageous:

•         Excellent knowledge of cGMP's/FDA requirements.

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

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

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

•         Advanced skills in solving complex problems and the ability to bring issues to resolution.

•         Theoretical and practical knowledge in a wide variety of technologies for the recovery of therapeutic proteins.

•         Familiarity with protein characterization analytical techniques.

•         Familiarity with statistical experimental design methods.

•         Experience developing commercially relevant downstream processes to produce pharmacologically active proteins.

 

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