Develop the future of biologics
Imagine following the science and changing lives for the better – every single day. Join us and help us develop the future of biologics.
Our BioPharmaceutical Development team is a fully integrated global organization, with facilities in Gaithersburg (US), San Francisco (US), Cambridge (UK) and Liverpool (UK). Passionate and proud of what we do, we’re developing our deep pipeline of new therapeutics by delivering projects from early research to late stage development – for example, we’re currently working alongside AZ Biologics Operations in the annual virus strain development for our commercial influenza vaccine. We combine a bold ambition with huge potential. Contribute to our growth at this exciting time and you’ll be immersing yourself in cutting-edge science you won’t find everywhere, in a way you won’t find anywhere.
Breaking new ground to improve patient outcomes
We’re hands-on, take ownership and run with our ideas. We have an open and collaborative culture. And we combine the agility of a bio-tech with the scale and support you’d expect from a large, global pharmaceutical company.
BioPharmaceutical Development at AstraZeneca brings together diverse minds united in breaking new ground to improve patient outcomes. You’ll have the opportunity to work with a variety of molecular formats across multiple therapeutic areas. You’ll also take an adaptable, science-driven approach and apply cutting-edge technologies to develop industry-leading cell lines, production processes, analytical methods, formulations, and drug delivery and devices.
Our innovative team develops high-yielding, efficient production processes for even the most challenging and novel molecules. We’re providing clinical products with stable formulations and developing a range of drug delivery options. In combination with advanced device development, we’re creating medicines that patients want to use.
Our team
Our team members share a bold ambition of constantly pushing the boundaries of science and creating innovative ways to make and deliver life-changing medicines to patients. They have a passion for discovery and a pipeline to show for it. Here, you’ll have the opportunity to make a difference in people’s lives every day. There are many functional areas within BPD with many opportunities to showcase your scientific knowledge and passion:
CMC Team Management
CMC Team Management encompasses BPD Team Leads (TL) and CMC Project Managers (PM). BPD TL and CMC PM together lead the CMC Team that is responsible for development and manufacture of biological products from Lead Optimization to Product Launch. BPD TLs employ their technical expertise to formulate CMC Development strategy, working with the Functional Leads. CMC PMs lead the translation of strategy into project plans and deliverables for CMC Teams to implement. CMC PMs also ensure project deliverables are in line with time, cost, and quality requirements. BPD TL and CMC PM represent BPD at various governance bodies, while ensuring CMC Development strategy aligns with Product Development Plan developed by cross-functional project team. Both CMC PM and BPD TL partner with Global Technical Operations (GTO) for commercial process development, transfer, and manufacture. BPD TL and CMC PM form this unique partnership which results in successful development and manufacture of pre-clinical to commercial biopharmaceutical products.
Science Submission Management (SSM)
The Biopharmaceutical Development (BPD) Science Submission Management (SSM) team manages the authoring and review of documents that are submitted globally to regulatory agencies to support clinical development from First-in-Man trials through marketing applications. The team delivers well written, scientifically sound, and regulatory-compliant documents for all biologics in the AstraZeneca pipeline, thereby helping to deliver promising new medicines to patients. The SSM team includes Document Specialists who assist with formatting and quality control of regulatory submissions, manage the BPD technical report system (eHive), and support BioPharmaceutical Development and Regulatory CMC in the use of the AZ global regulatory document management and information system (ANGEL).
Data Science and Modelling
The group helps other BPD functions understand and get real value from their data, activities and processes, through all stages of a product's life cycle. They provide support across all aspects of data science from acquisition and laboratory automation through to experimental design, analysis and modelling. The team actively collaborates with scientists and engineers working in technical process development fields. And they also provide support with drug specification setting tasks, BLA submissions, interactions with regulatory agencies and post-approval activities.
BioProcess Technologies and Engineering
BioProcess Technologies and Engineering is enabling facility fit of off-platform and new modality processes as well as defining the future of bioprocess operations by leveraging strategic partnerships and facilitating advanced modelling methods in conjunction with sound engineering principles to survey, evaluate, and implement transformative solutions and technologies. We enable rapid delivery of cost-effective cures to patients by implementing state-of-the-art manufacturing and scale-up of bioprocesses through continuous innovation and engineering solutions.
Cell Culture Fermentation Sciences (CCFS)
CCFS designs, develops, optimises and validates cell culture and fermentation processes for a wide range of biological products. The team generates optimal cell lines and is also responsible for technology transfers into manufacturing. High throughput scale-down models are employed to develop media and processes to support production. The team has occupied a leadership position in industry in terms of antibody productivity and incorporates the latest developments in automation and analytics into its work.
Purification Process Sciences (PPS)
PPS designs, develops, optimises and validates purification processes for a wide range of biological products including monoclonal antibodies, therapeutic proteins, therapeutic oligonucleotides, viral and cellular therapies. They utilise current state-of-the-art capabilities, enabling cost effective and streamlined manufacturing. Their work makes sure that products are high quality and safe for patients to use. Innovating and bringing in external developments, they’re at the forefront of separation technologies.
Dosage Form Design and Development (DFDD)
The Dosage Form Design and Development organization develops pharmaceutically stable, competitive, patient-centric biopharmaceutical dosage forms, including formulations, drug delivery systems, and delivery devices for clinical and commercial use. Formulation Sciences assesses molecule developability, and develops stable, robust clinical and commercial formulations for the diverse molecular modalities in the biologics portfolio. Device Development develops drug/device combination products, including syringes, pens, auto-injectors, on-body injectors, inhalation devices, smart devices and more. Drug Delivery develops innovative drug delivery systems for targeted drug delivery and controlled release. Process Engineering and Packaging assesses dosage form manufacturability, and develops robust packaging, fill/finish and device assembly manufacturing process for all of our drug products, devices and delivery systems. We execute our work based through scientific excellence, a deep understanding of the needs of patients and clinicians, smart development strategies, collaboration within and across functions, and actively analyzing the evolving external landscape. Our organization develops our people by providing opportunities to learn across the diverse scientific and engineering disciplines that are employed for the design and technical development of patient centric dosage forms.
Quantitative Sciences
The group helps other BPD functions understand and get real value from their data, activities and processes, through all stages of a product's life cycle. They do everything from experimental design and analysis for specific studies, simulation of clinical manufacturing processes through to modelling the entire BPD project portfolio. The team actively collaborates with scientists and engineers working in technical process development fields. And they also provide support with drug specification setting tasks, BLA submissions, interactions with regulatory agencies and post-approval activities.
Flu-MSAT
The Flu Manufacturing Science and Technology group handles all R&D associated activities linked to the supply of AstraZeneca’s commercially available, live attenuated influenza vaccine (LAIV) that’s used every year to vaccinate children. They’re multi-disciplinary and experts in Virology, Upstream and Downstream Process Development and Analytical Development.
Analytical Sciences Group
The team develops state-of-the-art physicochemical analytical methods and uses the full range of analytical techniques and imaging analyses to detect, characterize, and quantify product variants ranging from single atomic modifications to visible particles. Structural properties are assessed for their potential to impact to patient safety and product efficacy. They work with a range of molecules including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and other novel products such as parenteral and oral dosage synthetic peptides, therapeutic viruses, and nucleic acid products. The team supports product and process development from emergence out of basic research, throughout clinical trials, and then supports commercial operations. For instance, they help to create appropriate manufacturing monitoring and control strategies and present analytical knowledge to health authorities in regulatory submissions.
Logistics and Clinical Supply (LCS)
The (LCS) team is responsible for drug supply strategy, meaning that they manage and assure the labelling, packaging and distribution of investigational medicinal product to clinical studies around the world. Because they work collaboratively, they make sure BPD is agile enough to respond to portfolio demand. They look to supply high quality clinical products that meet patient needs, every time.
Bioassay Group
Working collaboratively and with outstanding people, this highly technical group focuses on developing, optimizing and validating functional and impurity methods to support the characterization, GMP lot release, stability and in-process testing of biotherapeutic products to address unmet medical needs. They work with a range of molecules including peptides, monoclonal antibodies, antibody-drug-conjugates, bispecifics, as well as novel biotherapeutic modalities. They collaborate with basic research colleagues to understand the post-translational modifications in drugs that impact function. The in vitro assays they develop detect and measure the levels of impurities which are important safety and immunogenicity concerns. The group generates data which provides assurance that our biotherapeutic products perform as intended.
Manufacturing Sciences
This team is key to bringing amazing science to patients. They provide flexible, fully-integrated process scale-up and bio-manufacturing functionality, using a range of technologies to produce the pre-clinical and early through late stage clinical drug products that advance our pipeline. The team also actively collaborates with its counterparts in technical process development; provides cGMP manufacturing of cell banks; manages and assures the supply of raw materials; performs non-conformance identification and resolution activities; and provides integrated engineering, technical service, and process automation functions.
Rotational Associates Programme
The Rotational Associates Programme is a two-year programme that enables recent graduates to join us in making a difference to people’s lives every day. The programme comprises three eight-month rotational assignments across various functions within BPD. Participants work on challenging technical projects supporting the development of protein therapeutics in the areas of cell culture and fermentation, purification, analytics and protein characterization, formulation, delivery devices, clinical logistics and manufacturing.
Who we look for
In our highly energized environment, the potential for growth is immense. Opportunities for professional development and learning are far-reaching. Challenge and professional satisfaction are constants.
We look for entrepreneurial individuals who have the the confidence to take brave decisions, learn from their mistakes and are bold in pioneering new approaches to improve patients’ lives. In our collaborative community, you’ll enjoy liaising with specialists from different spheres, supporting and learning from colleagues, and applying different perspectives to your work.
You'll thrive in an atmosphere that encourages you to think on your feet, and adapt your approach to develop ground-breaking solutions to uniquely complex problems. A critical thinker, you’ll have a natural scientific curiosity for solving problems and making continuous improvements. You’ll embrace change and the new challenges it brings every day, and you’ll welcome the scope we’ll give you to apply your judgement and drive our operations forward for the benefits of patients.
Why join BioPharmaceutical Development at AstraZeneca
If you’re inspired by the possibilities of science and the prospect of meeting patients’ needs around the world, join us in BioPharmaceutical Development at AstraZeneca.
Taking your place among a team of innovators and collaborators, you’ll work on projects across the whole life cycle of a molecule and get to see your science turned into medicines that transform patients’ lives. You’ll have the scope to work in areas beyond your job description, experiment with new technologies, collaborate with our partners on joint projects and challenge the norm – we value people who think differently and constantly push the science. Outstanding resources and an investment in training and development will help you to realise your full potential and we’ll also help you to get your work published.
If you believe you could contribute to our growth at this exciting time, review our latest opportunities below.
