Senior Scientist, Process Engineering & Packaging

Job content

Cambridge, United Kingdom

Competitive Salary & Benefits

Closing Date: Thursday 3rd November 2022

Make a more meaningful impact on patients’ lives around the globe

At AstraZeneca, you’ll have the chance to create a meaningful difference in patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes, and shaping the patient ecosystem.

Site Description

Welcome to Granta Park Cambridge, UK, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you… Granta Park has a newly built gym with swimming pool, nursery and central food hub accessible to staff as part of the science park facilities. We also have our own bistro and deli in the AstraZeneca buildings. There are regular ‘Lunch & Learn’ events and after-work socials with snacks and drinks on the last Friday of every month. This is our biggest and most spacious lab site in Cambridge…come and join us!

About The Business Group – Process Engineering And Packaging (PEP)

The Process Engineering and Packaging (PEP) group sits within the BioPharmaceutical Development (BPD) function at AstraZeneca. This department consists of scientists, engineers, mathematicians, and project managers whose ambition is to transform biological molecules into life-changing medicines. The PEP group has accountability for drug product process development, process characterization, combination product assembly development, and packaging science and technology across a broad range of biotech product types and technologies. We support the entire portfolio from Phase 1 clinical trial materials through to marketing application and product launch.

What You’ll Do

As Process Engineering & Packaging Senior Scientist, you will be responsible for the process development and packaging of late-stage clinical products; and the development of robust drug product and device assembly processes for commercial production (in collaboration with Operations). In addition, you will apply technology transfer to both internal and outsourced commercial manufacturing; and ensure the development and maturation of a sophisticated scale-down fill/finish development lab for technical support of clinical and commercial production.

You will help build the process development of a diverse group of biopharmaceutical dosage forms, including liquid and lyophilized formulations, various primary container formats, and novel drug delivery formulations (e.g., nanoparticles and high concentration formulations).

In this role, you must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces. These positions require effective collaborative interactions, particularly with the Global Biological Operations (Commercial Operations) organization and internal/external manufacturing sites within the manufacturing network.

Please note that this position may require up to 25% travel around the UK and EU

Main Duties And Responsibilities

• Developing drug product processes. This includes taking accountability for design for manufacturing, development and technical support of clinical processes and support of commercial packaging, technology transfer to Global Biological Operations, and ad-hoc technical support for commercial production as needed
• Applying scientific and engineering knowledge to tackle problems arising during manufacture or process development
• Drive a culture of innovation and high-quality science and engineering
• Challenge the status quo, yet build positive relationships with other team members and functional partners
  
  

Essential Requirements

• BSc, MSc or PhD in Biotechnology, Chemical Engineering, or another relevant engineering / scientific qualification
• Significant experience in drug process development and CMC aspects of BioPharmaceutical development
• Strong experience with technology transfer to external global partners
• Proven technical and scientific skills with confirmed experience in the development of drug manufacturing processes for biologics in primary containers and devices
  
  

Desirable Requirements

• Knowledge of QRM and Six Sigma principles and tools
• Knowledge of assembly, label and packing processes & equipment
• Knowledge of combination product and/or medical device development and associated design controls
• Effective non-conformance investigation and root analysis
• Experience working with formulation development
• Experience with lyophilization development, characterization and scale-up
• Experience with novel and new biotech modalities (mRNA, adenovirus delivery, CAR-T therapies, ATMP, antibody-drug conjugates, etc.)
  
  

Behavioural Requirements

• Strong collaborator with the ability to build and maintain effective working relationships and willing to challenge behaviours and actions
• Collaborative work ethic with the ability to work internally and externally across a wide range of partners.
• Ability to influence senior leaders and partners
• Ability to work independently under own initiative in an environment with high peer pressure, whilst maintaining high ethical standards and integrity
• Ability to work collaboratively with multiple technical functions. These include late-stage formulation development, device development, clinical operations, supply chain, quality and regulatory functions
  
  

So, what’s next?

This role is open from Thursday 20th October 2022, and we encourage your application no later than Thursday 3rd November 2022.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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