Senior Scientist - Oligonucleotide
4 days left
- Experience Level
- Experienced (non-manager)
Senior Scientist - Oligonucleotide
Salary & Benefits Competitive
Make a more meaningful impact to patients' lives around the globe
Here you'll have the opportunity to make a meaningful difference to 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.
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.
In Pharmaceutical Technology and Development (PT&D), we are the bridge between forward-thinking science and innovative medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, 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.
We are currently recruiting for a Senior Scientist with experience in the areas of oligonucleotide or peptide analysis to join our analytical group within New Modalities and Parenteral development (NMPD) who are dedicated to the CMC development and manufacture of new drug products.
You will join a vibrant team that is working on the next generation of medicines and playing a key role in the analytical development of new medicinal products. Bring your experience in the areas of oligonucleotide or peptide analysis and your strong analytical perspective to the team and be a leader in the late stage development of drug products.
You will deliver analytical knowledge that encompasses understanding of manufacturing processes, control strategy and robustness. You will also work cross functionally with multiple internal and external interfaces, supporting drug projects from the early clinical phase through to commercial filings.
This is your opportunity to deliver medicines that have a direct impact on patients' lives!
Main Duties and Responsibilities:
- Lead drug product analytical activities to support project progression during clinical development phases through to commercialisation
- Plan and execute experimental work in accordance with project timelines
- Shape analytical oligonucleotide and peptide strategy in collaboration with key partners within and external to the function.
- Develop analytical control strategies for new medicinal products within the New Modalities portfolio, leading to the registration of new medicines.
- Demonstrate scientific leadership to facilitate strategic development of drug projects
- Coach and develop junior colleagues, supporting them in reaching their full potential;
- Understand the external regulatory environment and support the development of AstraZeneca's regulatory strategy
- Deliver CMC content or contributions to regulatory filings and preparation of successful query responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements.
- Identify and solve analytical project issues.
Qualifications, Skills, Knowledge and Experience;
- BSc, MSc or equivalent in a relevant subject area with a proven track record in the pharmaceutical environment or a PhD with significant experience of working with oligonucleotide and/or peptide modalities.
- A strong understanding of key analytical techniques for the analysis and characterisation of large molecules (ideally oligonucleotide or peptide modalities), especially chromatography and mass spectrometry.
- Experience of characterising and developing analytical methods for large molecules.
- An understanding of the principles and management of Safety, Health & Environment (SHE) and cGMP.
- Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.
- Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of utilising risk based approaches for successful delivery.
- Ability to think and operate across boundaries, challenge the status quo and seek opportunities for business improvement.
- Effective influencing and prioritisation skills to ensure project delivery
- Good communication and partner skills, able to discuss complex ideas in a simple, easy to understand manner.
- Collaborative work ethic with the ability to work internally and externally across a wide range of partners.
- Excellent problem solving skills.
- Expertise in the use of High Resolution Mass Spectrometry in analysis of oligonucleotide or peptide modalities.
- Expertise in complex data analysis and digital science.
- Knowledge of and practical experience of implementing control strategies (quality by design or equivalent) to define the requirements for ensuring the quality of drug products.
- Knowledge of and practical experience of quality and regulatory requirements (e.g. GMP and ICH), technology transfers and method validation.
- Experience of supporting clinical manufacture and working with contract manufacturing organisations.
- Experience of authoring CMC content for the analytical aspects of drug product regulatory filings throughout the clinical development phase.
- Experience of delivering the analytical contribution to parenteral products
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
So, what's next?
Complete your application before the below closing date.
This role is open from 04/05/2021 and we welcome your application no later than 18/05/2021.
Please note applications must include your CV and a covering letter which presents your areas of strength / development and why you should be considered for the role.
Where can I find out more?
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