* Implementation and operation of purification unit operations into the Protein Production
Laboratory (PPL) in a cGMP environment.
* Oversee a team of 5-6 personnel performing all aspects of purification processing in a cGMP
* Oversee a team of 2-3 personnel performing the buffer preparation for all PPL user groups in
a cGMP environment.
* Interact with research and development groups to insure effective technology transfer.
* Schedule all purification processing and buffer prep activities and apply resources to
insure completion of company goals.
* Develop staffing, budgeting, and training for purification and buffer preparation
* Develop the infrastructure necessary for all aspects of purification processing.
* Lead the execution of validation activities in the purification and buffer preparation
* Function as a technical resource for the development and operation of purification
* Develop and review cGMP documentation for all purification processing and buffer preparation
* Define and maintain spare parts inventory for purification and buffer prep related
* Participate in interdisciplinary and multinational project teams as the drug substance
representative representing manufacturing, process development and analytical testing.
* Write and review the relevant sections of the dossier for the filing of the investigational