Sep 8, 2022
This role will provide non-testing support to the QC Analytical department for product life cycle management and technology transfer activities. This scope includes coordination of generating validation and transfer documents to support monoclonal antibody product life cycle and transfer between Pfizer sites. The technical skills within the scope will require an understanding of the scientific principles of test methods, data analysis, and cGMP requirements. The candidate will be responsible for facilitating lifecycle management and tech transfer through collaboration with laboratory subject matter experts (SMEs) and analysts.
Authoring method validation and transfer documents using Pfizer document workflow, through collaboration with SMEs
Supporting lab testing by reviewing data and documents for accuracy and compliance.
Supporting assay improvement activities and generating supporting documents.
Participating in across site meeting and tracking the project timeline
Supporting critical reagent, reference material and change control activities
Communicating with receiving laboratory, SME and supporting gap assessment, sample request and queries for technical transfer
Knowledge of the method validation and transfer regulatory guidelines
Scientific background in analytical methods, including HPLC, iCE, CGE, ELISA and bioassay.
Knowledge of QC analytical support and technical writing
Strong interpersonal and written communication skills
A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation
A degree in science, preferably in biochemistry, analytical chemistry or related technical discipline
Past experience supporting GMP writing in the biopharmaceutical field is preferred but not required