Technical Manager - Analytical Chemistry

Are you an experienced scientist looking for a role where your expertise can make an outstanding impact? Can you envision joining a dynamic and enthusiastic environment, delivering critical support to drug development projects? Then this is the place for you!

AstraZeneca is a global, innovative BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease.

We have two exciting opportunities to join as Technical Manager - Analytical Chemistry - one permanent role and one 12 month fixed term role. You'll be part of Manufacturing Science and Technology (MS&T), On-market technical function.

We're part of the Pharmaceutical Technology & Development (PT&D) organisation, responsible for drug product design, development and technical support for drug substance and products throughout the life cycle.

MS&T is a multi-skilled organisation based in 7 locations in 5 countries, and we provide the expert technical support for AstraZeneca commercial oral solid dosage (OSD) products. Our technical support and expertise spans from product formulation, manufacture, process engineering, statistics, modelling to devices and testing. The areas in which we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk and manufacturability.

What you'll do
As Technical Manager - Analytical Chemistry, you will be the responsible specialist for a major commercial product or group of products related to the Analytical Methods subject matter area. Using your knowledge in analytical methods, you will provide expertise and leadership to aid in the resolution of analytical method issues and complaints impacting supply and proactively find opportunities for analytical method improvements. We will also rely on you to train and mentor colleagues and partners in methods used in your expert field.

Furthermore, you'll be responsible for the technical support during the transfer of established product analytical methods within sites as well as to external manufacturing partners.

Your main accountabilities will include:

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Development of suitable corrective and preventive actions in support of investigations
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Lead, assess impact and support complex technical improvements or change activities, assuring product and methods performance
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Responsible for analytical method lifecycle activities to ensure performance and compliance across sites
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Provide support for regulatory file authoring, review, license renewals and response to questions
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Design and execute experimental laboratory work when needed to support issues investigations, process/method changes and improvements



Essential for the role

You have a MSc or PhD degree, complemented with considerable experience in an appropriate subject area such as Chemistry, Pharmacy, Pharmaceutical Sciences or similar. Your knowledge spans all the commercial product requirements in the areas of analytical methods establishment and optimisation, including control of drug products, biopharmaceutics, stability, trace analysis (e.g. elemental impurities, extractables & leachables).

You have phenomenal interpersonal skills and proven track record to lead and collaborate across functions and locations.

You also have:

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Proven knowledge of a broad range of Analytical techniques (standard and non-standard)
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Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance.
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Significant experience on issue investigation and change assessment from analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc.)
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A detailed understanding of principles, applications and management of SHE and cGMP
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Experience in Operations or R&D with a track record of successful project delivery
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Understanding of a broad range of Analytical techniques (standard and non-standard) and good direct experience with standard techniques for OSD testing, including capability to run experimental lab work when needed



Desired for the role

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Experience in or exposure to multiple subject areas in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
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Previous experience and training in Lean, problem solving tools and have experience in data analysis and interpretation
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Strong leadership skills and behaviors with demonstration of being able to work across different functions





So, what's next!

If you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be.

We look forward to find out more about you - make sure you apply before September 5th, 2021.



Where can I find out more?

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