Molecule Steward (Senior Director) - Inhalation Products

GSK

7d•Hybrid

About The Position

The Molecule Steward (Sr Director) is the single point of end-to-end technical accountability for a portfolio of inhalation products, including DS, DP, inspection, assembly, packing and related support activities, providing strategic technical leadership to ensure successful new product introduction, and improvements across the lifecycle (e.g. quality, robustness and productivity). The Molecule Steward (Sr Director) is aligned to a new asset at Commit to Commercial Design with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward co-ordinates Drug Substance, Drug Product, Analytical Strategy and Device Lead to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control through product lifecycle. The Molecule Steward (Sr Director) is responsible for developing and delivering the technical elements of the GSC strategy for inhalation products with the GSC Strategic Lead. The Molecule Steward (Sr Director) will be the recognised expert in inhalation products and in addition to strategic technical leadership, the role will be expected to provide deep technical expertise where required to ensure highest levels of quality and robustness.

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

Nice To Haves

Strong communication skills in English and experience presenting technical information to diverse audiences.
Experience using risk-based approaches and project management tools.
Knowledge of global regulatory pathways for clinical development.
Comfort working in matrixed and cross-cultural teams.

Responsibilities

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 main
Must develop and manage strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D and maintain and develop technical talent through mentoring across network, with effective and clear communication on highly technical topics.
Must be able to manage stakeholders effectively.
Demonstrated knowledge of risk management approaches.