Assoc. Princ. Engineer Excipient & API Micronisation

Associate Principal Engineer Excipient & API Micronisation, conditioning & spray drying Inhalation

productsAstraZeneca is a global, innovation-driven bio-pharmaceutical business that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world's most serious diseases.

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.

Technical Operations Science & Innovation (TOSI) is part of PT&D and is a multi-skilled organisation with global footprint and provides the expert technical support for AstraZeneca commercial synthetic drug products (OSDs, parenteral and inhalation products). Our technical support and expertise spans from product formulation, manufacture, process engineering, statistics and modelling, to devices, packing and analytical sciences & technology. The areas in which we deploy our technical expertise are in the support of new product introduction, drug product, processes and methods improvements, changes, technology transfers, investigations, regulatory submissions and related interaction with authorities, product robustness, validation, risks evaluation and manufacturability.

PT&D TOSI Inhalation team is responsible for providing expert technical support to commercial products manufactured internally at AZ sites and externally at contractors. This team is also involved during the development phase of products and manufacturing processes.

This role is relevant for on market technical leaders whose subject matter expertise in Process Engineering & Technology for the manufacture of excipients and APIs, in development or in the commercial phase. This includes micronisation, conditioning and spray drying of current and future APIs and excipients used in AZ inhalation products.

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 has therefore a significant impact on both financial and reputational aspects of the business.

What you'll do

In your role as Associate Principal Engineer, you will develop a strategy and capability build for the creation and maintaining of all inhalation micronized, conditioned and spray dried APIs and excipients. You will be responsible for provision of technical expertise to aid in the resolution of manufacturing/method/formulation issues and complaints impacting supply or manufacturability. You will be responsible for the technical support in the event of product recall incidents and during the transfer of established products within sites and to external manufacturing partners including support for equivalency determination as applicable.

You could also be representing the manufacturing sites during the New Product Introduction phase, working with the development team and manufacturing sites.

Other responsibilities include:

* Developing, leading, and supporting a prioritized portfolio of project activities, with appropriate demand and supply oversight.
* Leading and assessing impact of complex technical improvements or change activities e.g. related to equipment and/or processes assuring product performance.
* Developing suitable corrective and preventive actions, e.g. in support of equipment related investigations.
* Regulatory file authoring, review, license renewals and response to questions.
* Leading global review of product performance via appropriate dashboards/CPV assessments to ensure product and process robustness.
* Supporting the development of the Manufacturing Technology Strategy within the area of expertise and cooperating with manufacturing sites to implement the strategy.
* Supporting for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeial standards).
* Providing technical leadership to Issue Management Team (IMT).
* Executing technical leadership and influencing in Pharmaceutical Teams and within TOSI.
* Provision of training in subject matter expertise areas including new equipment or processes
* Projecting resource estimations to support the budgeting process.

Essential requirements

* Likely to be educated to BSc, MSc, or PhD level in an appropriate subject area, with extensive years' experience relevant to the pharmaceutical industry and have professional credibility within the business and industry.
* In depth understanding of multiple disciplines, such as micronisation, spray drying, analytical, formulation, process engineering, modelling or validation.
* Excellent understanding of the overall drug development and commercialization process from development, launch and through life cycle management
* Experience in Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
* Excellent communicator with strong interpersonal skills.
* Detailed understanding of principles, applications and management of SHE and cGMP.
* Trained in assigned core capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity, change management and product security.



So, what's next?

We welcome your application no later than January 24th, 2023.