Peer Reviewer for TR 74 (Revision): Reprocessing and Reworking of Biologicals

TR 74 provides guidance in the design, development, controls, procedures, validation, regulatory submission, and implementation of reprocessing procedures for recombinant biopharmaceutical manufacturing. The information presented focuses on recombinant biopharmaceutical products including proteins and polypeptides produced via recombinant and non-recombinant cell-culture expression systems. The revision has been expanded to include a section on Reworking.

PDA technical documents rely on the contributions of subject matter experts from the industry. Peer Reviewers from all levels of experience and geographies are encouraged to participate to ensure the documents are accessible and relevant to a wide audience.

This is a virtual position.

Please note this opportunity is available to members and non-members.

If you are interested in joining this team, please submit your application by completing the survey.