USP Operator

About the role

The USP Operator perform the operations involved in the USP department in Gene Therapy in order to achieve the objectives of the organization ensuring proper compliance with Good Manufacturing Practices to achieve strategic objectives, promote the growth of people and facilitate communication and cooperation with other departments of the organization, in order to support customers from development to commercial manufacture of gene therapy drugs to obtain the best quality product at the right time and scale.

Key Tasks:

• Preparation of cultures, cell expansion, freezing/thawing, etc.
• Prepare media and reagents necessary for cell culture and viral vector production.
• Prepare materials needed for production batches.
• Internal maintenance of equipment and cleaning of equipment and associated documents.
• Collaborate in the elaboration of SOPs and specific records of the Production Area (Upstream).
• Fulfill the records associated with SOPs. Fulfillment of Methodical corresponding to the Upstream stages.
• Participate in production batches at the development laboratory and classified rooms level.
• Create working environment with the rest of the USP department based on company values.
• Receive the appropriate training for their work position in Health and Safety matters and ensure compliance within.
• Comply with the corporate legal framework (Compliance Policies).
• Collaborate in all those tasks required by the management.

Key Working Relation:

• USP department.