Associate Principal Scientist

Introduction to role

Pharmaceutical Technology & Development (PT&D) is a critical function within AstraZeneca's R&D organisation, responsible for developing robust chemical processes and analytical methods for new medicines. We are currently looking for an Associate Principal Scientist - Analytical to play a key role in our Technical Operations Science and Innovation (TOSI) organization which is part of PT&D.

TOSI provides technical support and expertise related to products, manufacturing, analytical, process engineering, statistics, modelling, 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. 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 a major commercial product or group of products related to the Analytical subject matter area e.g. Oral Solid Dosage formulations, parenterals formulations, Oligonucleotides etc.

• Leadership and support for regulatory file authoring, review, license renewals and response to questions

• Provision of strong technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply.

• Development of suitable corrective and preventive actions in support of investigations.

• Responsible for the 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 & support complex technical improvements or change activities assuring product and methods performance.

• Responsible for analytical method lifecycle activities to ensure performance and compliance across sites.

• Find opportunities for analytical method improvements.

• Provision of training in subject matter expertise areas.

Essential Skills/Experience

• Bachelors degree or equivalent experience with professional working experience in a relevant field such as pharmaceuticals, chemistry, biotechnology, or life sciences

• Experience of preparing regulatory submission and responses to regulatory questions

• Excellent understanding of OSD products life-cycle, from launch and through life cycle management until discontinuation.

• Understanding of commercial product requirements in the areas of 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.

• Significant experience on issue investigation and change assessment from an analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc…)

• A detailed understanding of principles, applications and management of SHE and cGMP.

• Evidence of excellent communication skills and build excellent relationships with customers.

Desirable Skills/Experience

• Master's Degree with relevant work experience or PhD with demonstrated ability in a relevant industry such as pharmaceuticals

• Experience in or exposure to multiple subject areas in CMC and related functions (eg 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 behaviours 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.

Make a meaningful impact on people's lives with life-changing medicines. Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It's inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people's lives better from patients and their families to all of us in society.

Ready to make a difference? Apply now!

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 authorization and employment eligibility verification requirements.