The Analytical Product Owner Manager will supervise other APOs in the Biologics Global Product Support group.
- Ensure an aligned strategy for the APOs in the group.
- Ensure APOs are fulfilling their job responsibilities and act as support when APOs have questions.
- Ensure commercial APO strategies are aligned with process development APO strategies.
The Analytical Product Owner Manager is accountable for the technical continuum of analytical methods and strategies for several late phase and commercial products.
- Act as an expert in analytical development of biologics, serving as the point of contact of the TOPT PDTS subteam for analytical methods life cycle management and analytical support of commercial biotherapeutics
- Contributes as part of a team of SMEs to define, prioritize and execute the analytical methods development projects throughout the product’s lifecycle.
- Manages product specific analytical development plans and provide technical justification of product specification
- Overview of analytical comparability studies for the products and coordination of the involved groups
- Authoring/reviewing regulatory filing CMC analytical sections and responses to health authority questions.
- Provide/coordinate SME support for PV strategies and major process and methods investigations.
- Accountable for external lab management
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
Supervise APOs within Biologics Global Product Support Team
Prepare justification of specifications section review and approve several analytical chapters in BLA/MAA
Overview of analytical comparability studies for the products and coordination of the involved groups
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
Support analytical method transfer plans and timelines, and PV strategy
Represents Shire Process development biologics and analytical
Education and Experience Requirements
- Analytical development expert with extensive experiences on method development, characterization and CMC analytical strategy in biologics development, regulatory agency interaction experiences.
- Experience leading a team
- MS with 13 yrs relevant experience or BS with 15 yrs relevant experience will also be considered
- PhD with 10 yrs relevant experience preferred.
Key Skills, Abilities, and Competencies
The following items are essential:
- Direct experience with the analytical support of biologics process development and formulation development, in-process testing and characterization
- 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.
- Knowledge of ICH and other regulatory guidelines
- Knowledge and experience with product development and clinical supplies processes
- Experience in authoring analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions
- Experience working with Contract Research Laboratories
- Experience in support product life cycle and application of process analytical technology improvements
The following items are preferred:
- Knowledge and experience with statistical applications for data evaluation
- Knowledge in European, Japanese, Chinese and US CMC regulatory requirements for Biologics
- Strong project management skills with ability to deliver results with effective communication with cross-functional stakeholders
- Strong verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues to non-technical audience
Location/Region: Lexington, MA