Associate Principal Scientist

8 months ago

Macclesfield, United Kingdom AstraZeneca Full time

**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 the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better.

**Technical Operations, Science and Innovation (TOSI) Function**:
The function provides the expert technical support for AstraZeneca commercial products. It is a multi-skilled, cross-functional organisation that provides technical support and expertise related to drug product formulation, manufacture, process engineering, statistics, modelling, devices and testing. The key activities where 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.

**The role**

As an Associate Principal Scientist, you will be responsible for our microbiology contribution to the maintenance and optimisation of supply for products, meeting cost and quality targets for our customers.

This includes the following responsibilities:

- Responsible expert for microbiological and aseptic manufacturing matters for commercial products
- Identifying, risk assessing and solving potential issues and acting as an interface between departments.
- Lead, assess impact and support complex technical improvements or change activities, assuring microbiological product quality.
- Responsible for lifecycle activities to ensure equivalence across sites e.g., specifications, methods, processes.
- Maintain a technical support model with outstanding customer service for AZ manufacturing sites and external manufacturing/testing partners.
- Improving manufacturing and wider microbiology control strategies to ensure appropriate quality and robustness of commercial products according to current regulatory guidance.
- Maintain technical knowledge in new manufacturing technologies, including up-to-date advances in new technologies to aid in the improvement of microbiological testing and control.
- Provide support for regulatory file authoring, review, license renewals, response to questions and development of suitable corrective and preventive actions in investigations.
- Executing technical leadership and influencing in Pharmaceutical Teams, within TOSI and wider.
- Build effective networks across the Global Operations organisation.

**Essential Requirements**:

- A BSc in Microbiology or closely related Biological Science with significant and relevant post degree experience in microbiology in the pharmaceutical industry or the equivalent in experience.
- Experience of supporting the microbiological aspects of pharmaceutical manufacture and working with external contract manufacturing organisations.
- Understanding of a broad range of GMP aspects of microbiological controls and regulations with experience of GMP inspections or audits.
- Evidence of excellent communication skills and the ability to build excellent relationships with customers.

**Preferred Requirements**:

- Experience in sterile manufacturing with an understanding of the full suite of microbiological test methods.
- Strong leadership skills and behaviours that will enable you to work across different functions and challenge the status quo to seek opportunities for business improvement.
- Experience in the authoring of regulatory submissions and responses to regulatory authorities.

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