The Analytical Product Owner is accountable for the technical continuum of analytical methods and strategies for several late phase and commercial products.
Accountable for the analytical development plan for one or several commercial biologics
Point of contact for the TOPT PDTS subteam for analytical support of commercial bio therapeutics ensuring a seamless information flow between other functions (e.g. AD, local TS, CMC team, Regulatory, MFG, QC and Quality Management PQLs etc).
Support the analytical control strategy, change controls and risks assessments (including RACT / CQA assessments) for one or several commercial biologics
Provide/coordinate analytical SME support of major process and methods investigations
Contribute to the continuous improvement of methods based on analytical development plans, and regular review of methods robustness and IPC/CQA capabilities throughout the product life cycle of commercial biologics
Prepare justification of specifications section review and approve several analytical chapters in BLA/MAA
Support analytical method transfer plans and timelines, and PV strategy
Overview of analytical comparability studies for the products and coordination of the involved groups
Represents Shire Process development biologics and analytical development group at authority meetings and telecom for analytical questions
Education and Experience Requirements
Job Description Template
Shire’s Brave culture offers employees with diverse backgrounds the opportunity
to enable those with life altering conditions to lead better lives.
Key Skills, Abilities, and Competencies
The following items are essential:
o Direct experience with the analytical support of biologics process development and formulation development, in process testing and characterization
o Knowledge of complex and state-of-the-art methodology for biologics characterization and development of biologic products, including but not limited to, HPLC/UPLC, mass spectrometry, immunological methods, cell based assay, particulates characterization etc.
o Knowledge of ICH and other regulatory guidelines
o Knowledge and experience with product development and clinical supplies processes
o Experience in authoring analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions
o Experience working with Contract Research Laboratories
o Experience in support product life cycle and application of process analytical technology improvements
The following items are preferred:
Complexity and Problem Solving
Req ID: R0018803