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Drug Substance Analytical Project lead

Cheshire East
Full time
Posted
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AstraZeneca UK
Healthcare & medical
10,001+ employees
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Role Name: Drug Substance Analytical Project lead

Region: Macclesfield, UK

Competitive Benefits & Salary

Introduction to Role:
Are you a passionate and experienced professional in drug substance development? Do you have the drive to make a significant impact in the field of analytical science? If so, AstraZeneca is the perfect place for you! We are a global, innovation-driven biopharmaceutical company that follows the science to turn ideas into life-changing medicines. We are committed to sustainability and minimizing our environmental impact. At AstraZeneca, we foster a culture of innovation and collaboration, empowering our colleagues to be their authentic selves and feel valued, respected, and rewarded for their ideas and creativity.

Pharmaceutical Technology & Development:

Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into medicines that help millions of people. We work across the entire value chain, crafting and delivering active pharmaceutical ingredients (API) 's, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Drug Substance Development:

In Chemical Development or equivalent experience, we believe that nothing is impossible, and we are determined to push the boundaries of science to deliver medicines to patients. Focussed on late stage (Phase 2/3) and commercial drug substance, we combine technical knowledge and understanding with individual talent to define the commercial control strategy, drive design, development, and optimisation of synthetic routes and analytical methodologies that deliver medicines in a balanced, commercially viable way. As a department delivering scientific excellence, we are focussed on innovation, continuous improvement, sustainability, automation, and lifelong learning.

The department and analytical area are growing, we are recruiting strong analytical scientists across our small molecule, sophisticated modalities, and commercial drug substance projects, defining, and ensuring the next generation of medicines. You will employ analytical knowledge and problem-solving skills to lead all or part of the analytical and regulatory control strategy during the development of late phase and commercial project delivery. You will work independently leading and driving interactions within multi-functional teams, including Project management, Process Chemists, Engineers, Right Particle, Contract Manufacturing Organisations (CMOs), Pharmaceutical Product Development, Regulatory CMC, Quality Assurance and Supply Chain.

As part of a global company with a focus on developing its people, you will have the opportunity to develop both personally and authoritatively while helping to deliver innovative medicines across the globe.

Accountabilities:
As an Analytical Project Lead, you will play a crucial role in drug substance development. You will collaborate with process chemists, engineers, project managers, and other scientists to ensure successful project progression from late clinical development to launch or marketed product. Your responsibilities will include leading key activities related to the control strategy for drug substance, advising other scientists, leading analytical activities across the route of manufacture to drug substance, developing analytical control strategies, identifying and solving potential analytical project issues, driving continuous improvement, planning and conducting lab-based experimental work, supporting the technical development of other scientists, collaborating with internal and external manufacturing partners, and authoring the CMC components of regulatory submissions.

Essential Skills/Experience:
- A degree (BSc, MSc or equivalent experience) in Chemistry or Analytical Chemistry with a proven record of analytical in a pharmaceutical environment, or a PhD including aspects of analytical measurement.
- Experience in pharmaceutical development with analytical project leadership accountability.
- Knowledge and practical experience across a range of analytical techniques including liquid and gas chromatography, mass spectrometry and Nuclear Magnetic Resonance (NMR).
- Scientific leadership skills and the ability to use knowledge and experience to assess options available and deliver robust scientific contributions to projects.
- Strong problem-solving skills, underpinned by strong practical laboratory experience.
- A detailed appreciation of the principles and management of Safety, Health, and Environment (SHE) and Good Manufacturing Practice (cGMP).

Desirable Skills/Experience:
- Experience of working collaboratively within a mixed skill technical team and ability to develop and utilise networks.
- Ability to optimally lead improvement projects.
- Strong influencing, planning and prioritisation skills to ensure project delivery to deadlines.
- Experience of leading technical teams, mentor, and people development.
- Dedication to improvement and innovation and knowledge of lean principles.

- Knowledge and practical experience of quality and regulatory requirements (GMP and ICH), as well as health and safety requirements

3-5 days working from site as it is Lab- Based

At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We are constantly evolving how we work with Lean, cutting-edge science, digitalisation and sustainable practices. We thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. We are part of an inclusive community that supports each other on our journeys. We are intellectually stimulated by constant learning. There's potential for multiple global careers and great rewards for those who embrace the diverse opportunities.

Date Posted

28-Mar-2024

Closing Date

07-Apr-2024Our 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.