Associate Principal Scientist –Analytical, Inhalation products

AstraZeneca•Durham, NC

3d•Hybrid

About The Position

Join us at AstraZeneca, where we put patients first and strive to meet their unmet needs worldwide. We have an exciting opportunity to join our Technical Operations Science & Innovation (TOSI) team which is part of the Pharmaceutical Technology & Development (PT&D) organisation. This is your chance to make a meaningful impact on people's lives with life-changing medicines. This is an Associate Principal Scientist role. The Pharmaceutical Technology & Development (PT&D) organisation, part of Operations, is responsible for drug product design, development and technical support for drug substance and products throughout the life cycle. This role will have a significant impact on the overall success of Operations as well as ensuring the commercial viability of current products. The activities of the group help to ensure availability of all AstraZeneca products to the commercial organisation. The role therefore has a substantial impact on both financial and reputational aspects of the business. This role is based at AstraZeneca’s Durham, US site.

Requirements

Bachelor of Science in an appropriate subject area (e.g. Chemistry, Pharmacy, Analytical and Pharmaceutical Sciences) with proven experience relevant to the pharmaceutical industry, ideally on inhalation medicines.
5+ years of experience in multiple pharmaceutical development subject areas, such as, analytical, formulation, process engineering, stability, modelling and validation.
An understanding of the overall drug development and commercialisation process from development, launch and life cycle management.
Experience in Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
Detailed understanding of principles, applications and management of SHE and cGMP.

Nice To Haves

MS or PhD desirable.

Responsibilities

Provide expert technical analytical support to commercial Inhalation Products manufactured internally at AZ sites and externally at contract facilities.
Responsible for the provision of technical expertise to aid in the resolution of method/manufacturing/formulation issues and complaints impacting supply or manufacturability.
Deliver technical expertise to support product supply strategy projects and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
Represent the QC units during the New Product Introduction phase, working with the development team and manufacturing sites.
Support AZ manufacturing and QC testing sites, CMOs, and import labs to ensure performance, robustness and compliance of AZ commercial drug products and related analytical methods.
Execute practical problem-solving activities in support of issue investigations (OOS/OOT) and analytical methods lifecycle management.
Support major changes, business continuity plans and market access projects in collaboration with multiple functions (e.g., Global External Sourcing, Quality Assurance, Quality Control, Regulatory Affairs, and Manufacturing).
Execute analytical technology transfers of commercial products to multiple locations as well as support to local registrations and regulatory variations, including preparation of analytical parts of regulatory dossiers.
Assist in defining technical standards impacting commercial products specific to regulatory expectations and analytical standards (including pharmacopeial standards).
Execute Technical leadership and influencing in Pharmaceutical Teams and within TOSI.
Lead analytical methods improvements and analytical innovation projects for commercial products, in collaboration with other technical teams and Expert Working Groups.
Drive performance improvements, sustainability improvements, lead time reduction, enhanced control strategy, automation etc. in alignment with Ops 2030 and PT&D 2030 targets.