Contribute as part of a team of scientists to guide the development of analytical methods/projects in early clinical development. Create and maintain effective partnerships with stakeholders from Research, Analytical Development, Process Development, and Pilot Manufacturing operations to allow for candidate molecule transition into development.
- Serving as the point of contact for a cross-functional team carrying out program transitions
- Responsible for strategic planning, coordinating, and execution of:
- Analytical studies supporting the selection of candidate sequence and lead clone for the production cell line
- Material generation work to support early reference material, characterization and preclinical studies
- Studies which support the sequence liability and developability assessment prior to lead selection of research assets
- Planning and design of the early analytical control strategies. Manage the early analytical development plan and provide technical justification of
early product quality targets
35% Owns the analytical development plan and analytical control strategy aligned with the Shire sourcing strategy for a product family. Collaborate with cross functional stakeholder to develop and optimize business process to ensure successful implementation of analytical control strategies
35% Lead cross functional teams to perform to developability assessment for lead selection and research to development transition for portfolio of products.
10% Single point of contact outside of Analytical Development (other PDTS departments, CMC team, Research, Regulatory, MFG, QC and Quality Management PQLs etc)
15 % Ensure a continuous information flow between the AD analytical method development, characterization, innovation & PAT, high-thru-put test center.
5 % Contribute to develop of an operating model and continuous improvement of platforms based analytical development plans for the complete product life cycle for product families as the company growsEducation and Experience Requirements
Recognized analytical development expert with extensive experiences on method development, characterization and CMC analytical strategy in biologics development, proven successful regulatory agency interaction experiences. PhD preferred. MS with extensive experience will also be considered. Key Skills, Abilities, and Competencies
- Analytical science, cGMP compliance, regulatory requirements for method development
- The following items are essential:
- Direct knowledge and experience in protein chemistry and developability assessment
- Direct knowledge and experience in development analytical control strategy based on target product profile and critical quality attributes for early phase development projects
- 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. Direct experience in mass spectrometry is a plus
- 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 and phase appropriate requirements ( may be less critical )
- 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 in US, European, Japanese, and Chinese 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
- Ability to create collaborative and trusting relationships internally and with external partners.
- Exceptional problem solving and troubleshooting skills related to analytical methodology
- Proven knowledge and experience with statistical applications for data evaluation
- Requires strong organisational skills and attention to detail for composing and proofing materials, scheduling, establishing priorities, and meeting deadlines