Molecule Steward – Senior Director, Inhalation Products

Role Overview

• Responsible for defining and owning the technical strategy through a product’s lifecycle including (non-exhaustive list): product transfers R&D to GSK sites/ External manufacturing sites & Site to Site (both GSK sites and external manufacturing sites)
• Product Performance Qualification and Ongoing Continuous Process Verification
• Leading Product Technical Lifecycle Team (PTLT) and yearly Manufacturing Robustness Review Board meetings (MRRB) to ensure risks are identified, escalated, mitigated and resolved ensuring alignment and consistency across supply nodes
• Accountable for developing and delivering the Technical Lifecycle Plan (TLCP) including major geographical expansion requiring additional CMC activities on top of wave 1, new technologies and second-generation programs impacting the manufacturing process, analytical process, pack, device, and associated specifications
• Ensures that product history and knowledge from development through the product’s lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the GSC network
• Molecule steward is contributing as key inputter for process history file (PHF) reviewer and approver (if applicable)
• Providing technical leadership and subject matter expertise where required for multi-site investigations and/or critical deviations, troubleshooting, and major change programmes across supply nodes
• Stays current and maintains solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices
• Responsible for co-ordinating the technical review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SME’s and sites (if required)
• Representing MSAT, providing an MSAT single point accountable decision maker for GSC strategic team, CMC team, for established and new products, ensuring that a product control strategy is defined and maintained

Requirements

• Advanced degree in life sciences, pharmaceutical sciences, biochemical engineering or a related field
• PhD preferred
• Extensive years of experience in small molecules inhaled product development, analytical development or related area
• Proven experience in molecule stewardship, quality or formulation support across preclinical and clinical stages
• Track record of leading cross-functional teams and driving technical decisions
• Comprehensive knowledge of external regulatory requirements (FDA, EMA, MHRA, PMDA, etc.), and internal/external quality and safety requirements
• Experienced in technology transfer, with an understanding of the product development process
• Knowledge of current and emerging Regulatory Strategies (e.g. Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management
• Project management and prioritization skills gained within a complex matrix
• Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
• Excellent problem solver and ability to think and work creatively
• Demonstrated experience leading technical aspects of investigations
• Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management
• Demonstrated knowledge of Quality by Design and risk management approaches
• Strong technical acumen and communication, influencing skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and suppliers.
• Exceptional stakeholder management skills
• Able to lead and operate in an environment with high degree of change and uncertainty

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave