Overview In this role you will provide expert analytical support for commercial inhalation products, resolving method and formulation issues to safeguard supply. You will contribute to product supply strategy, business continuity, and lifecycle quality risk management, while representing QC during New Product Introduction. You'll collaborate with sites, CMOs, and regulatory teams to ensure compliance and robust analytical methods. The role offers leadership in technical projects, aiming to improve performance, sustainability, and control strategies within Ops 2030 and PT&D 2030.
Compensation / Benefits- Short-term incentive bonuses
- Equity-based awards for salaried roles
- Commissions for sales roles
- Qualified retirement programs
- Paid time off (vacation, holiday, leaves)
- Health, dental, and vision coverage
Responsibilities- Provide expert analytical support for commercial inhalation products across AZ sites and contract facilities
- Resolve method/manufacturing/formulation issues and complaints impacting supply or manufacturability
- Support product supply strategy projects and business continuity through drug product control and quality risk management activities
- Represent QC during New Product Introduction and collaborate with development and manufacturing teams
- Support manufacturing sites, CMOs, and import labs to ensure performance and regulatory compliance of analytical methods
- Lead issue investigations (OOS/OOT) and lifecycle management of analytical methods
- Coordinate analytical technology transfers of commercial products to multiple locations and support regulatory dossiers
- Define technical standards related to regulatory expectations and pharmacopeial standards
- Provide technical leadership within Pharmaceutical Teams and the TOSI group
- Drive analytical methods improvements and innovation projects, including automation, sustainability, and lead time reduction
- Align improvements with Ops 2030 and PT&D 2030 targets
Key requirements- Bachelor of Science in Chemistry, Pharmacy, Analytical or Pharmaceutical Sciences (MS or PhD desirable)
- 5+ years of experience in multiple pharmaceutical development areas (analytical, formulation, process engineering, stability, modelling, validation)
- Understanding of drug development and commercialization lifecycle
- Experience in Operations or R&D with proven project leadership in a matrix organization
- Strong knowledge of SHE and cGMP principles
- Problem-solving orientation
- Cross-functional collaboration
- Technical leadership and influence
- Analytical methods development and lifecycle management
- Regulatory dossier preparation support
- Analytical technology transfers
