GSK

Molecule Steward – Senior Director, Inhalation Products

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Ware • California • Massachusetts • United States

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Salary

💰 $220,275 - $367,125 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
molecule stewardshipanalytical developmenttechnology transferproject managementQuality by DesignGMPICH Q7ICH Q8ICH Q9ICH Q10
Soft Skills
problem solvingcreative thinkingstakeholder managementcommunicationinfluencingcross-functional collaborationleadershipprioritizationtechnical decision makingadaptability
Certifications
PhD in life sciencesPhD in pharmaceutical sciencesPhD in biochemical engineering