Associate Principal Scientist - Analytical Oligonucleotides
AstraZeneca AB / Kemistjobb / Göteborg
2024-10-30
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hela Sverige Are you looking for an opportunity where you can apply your technical expertise and leadership skills? Do you want to make a meaningful impact on people's lives with life-changing medicines? Join us in this exciting new opportunity at AstraZeneca Sweden!
We are currently looking for an experienced Associate Principal Scientist - Analytical Oligonucleotides to play a key role in our Technical Operations Science and Innovation (TOSI) organization.
As a leading player in the biopharmaceutical industry, AstraZeneca is at the forefront of delivering high-quality oligonucleotide products to market. TOSI provides technical support and expertise to on-market products, manufacturing, analytical, process engineering, statistics, modeling, devices, and testing. The areas in which we deploy our technical expertise include drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk, and manufacturability. We work closely with many technical functions across Global Operations, providing the ability to drive science and build capability within our organization and our ways of working.
Accountabilities
* Responsible expert for an Oligonucleotide commercial product or group of products related to the Analytical subject area.
* Provide strong technical expertise & leadership in complex Oligonucleotide analytical methodology and control strategy.
* Leadership and support for regulatory file authoring, review, license renewals, and response to questions, including coaching colleagues with these activities.
* Responsible for the transfer of established product analytical methods within sites and to external manufacturing partners, including support for equivalency determination and the ability to troubleshoot the complex Mass spectrometry methods.
* Lead, assess impact & support complex technical improvements, change activities, and analytical method lifecycle activities to ensure product and method performance.
* Stay current with industry trends, advances in analytical technology, and updated regulatory guidelines for oligonucleotide-based therapies.
Essential Skills/Experience
* BSc, MSc degree or PhD or equivalent experience level with considerable experience post degree in an appropriate subject area such as Chemistry, Pharmacy, Pharmaceutical Sciences or similar discipline.
* Excellent understanding of Oligonucleotide products' life-cycle and control strategies, from launch and through life cycle management until discontinuation.
* Understanding of commercial product requirements in the areas of Oligonucleotide analytical methods establishment and optimization (e.g. complex LC-MS methodology).
* Significant experience of preparing regulatory submission and responses to regulatory questions.
* Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance.
* Evidence of excellent communication skills and build excellent relationships with customers.
Desirable Skills/Experience
* Experience in or exposure to multiple subject areas in CMC and related functions (e.g., Product Development, Operations, Global Supply, Marketing Companies).
* Previous experience and training in Lean, problem-solving tools and have experience in data analysis and interpretation.
* Strong leadership skills and behaviors with demonstration of being able to work across different functions.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.
Ready to make a difference? Apply with your CV and cover letter no later than November 15th, 2024.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2024-11-09
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-211136".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 8985364