Senior Scientist - Analytical (TOSI)

We are seeking an experienced Senior Scientist - Analytical to join our global Technical Operations Science and Innovation (TOSI) organization. TOSI provides technical support and expertise in areas such as products, manufacturing, analytical processes, engineering, statistics, modeling, devices, and testing. Our technical expertise is deployed in drug product improvement projects, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk management, and manufacturability. Collaborating closely with various technical functions across Global Operations, we drive scientific advancement and build capability within our organization.

Your accountabilities will include:
- Serve as the responsible expert for major commercial products related to the Analytical subject matter area, such as Oral Solid Dosage formulations and parenterals formulations.
- Lead and support regulatory file authoring, review, license renewals, and response to questions.
- Provide strong technical expertise and leadership to resolve analytical method issues and complaints impacting supply.
- Develop suitable corrective and preventive actions in support of investigations.
- Offer technical support during the transfer of established product analytical methods within sites and to external manufacturing partners, including support for equivalency determination as applicable.
- Lead, assess impact, and support complex technical improvements or change activities ensuring product and methods performance.
- Manage analytical method lifecycle activities to ensure performance and compliance across sites.
- Identify opportunities for analytical method improvements.
- Provide analytical subject matter expertise and training.

Essential Skills/Experience:
- BSc or Master’s degree with a minimum of 5 years post-degree experience in Chemistry, Pharmacy, Pharmaceutical Sciences, or a similar discipline.
- Significant experience in preparing regulatory submissions and responses to regulatory questions.
- Excellent understanding of OSD products lifecycle management from launch to discontinuation.
- Knowledge of commercial product requirements around analytical methods establishment and optimization, control of drug products, biopharmaceutics, stability, trace analysis (e.g., elemental impurities, extractables & leachables).
- Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance.
- Experience in issue investigation and change assessment from an analytical perspective. Familiarity with standard tools for root cause analysis (5 whys, PPS, Level 0, etc.).
- Detailed understanding of principles, applications, and management of SHE and cGMP.
- Evidence of excellent communication skills and ability to build positive relationships with customers.

Desirable Skills/Experience:
- Experience or exposure to multiple disciplines in CMC and related functions (e.g., Product Development, Operations, Global Supply, Marketing Companies).
- Previous experience and training in Lean methodologies, problem-solving tools, and data analysis and interpretation.
- Strong leadership skills with the ability to work across functions.

AstraZeneca offers an environment where innovation abounds. With continuing new products and launches, there's never been a better time to join us. We embrace challenges as intellectually stimulating opportunities to learn more. Our resilience drives us forward as we continuously seek new ways to deliver life-changing medicines. Here you'll find a safe space where ideas are encouraged and rewarded. We work together as a team to push the boundaries of science and manufacturing perfection.

Ready to make an impact? Apply now to join our dynamic team at AstraZeneca!

External scientific community

Date Posted

11-Jul-2025

Closing Date

24-Jul-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.