AstraZeneca Pharmaceuticals LP Senior Scientists – Analytical in Macclesfield, United Kingdom
We are currently looking for Senior Scientists – Analytical in Global Product Development with scientific project based expertise.
You will join our Global Product Development (GPD) team in Pharmaceutical Technology and Development (PT&D), Macclesfield, UK.
We will rely on you to bring a strong analytical perspective to the team, leading our analytical strategy in a diverse, multi-skilled area, and supporting late stage development of formulated drug products. You will be responsible for delivering analytical knowledge that encompasses understanding of pharmaceutics, product performance, manufacturing processes, control strategy and robustness. You will join a vibrant team that is working on the next generation of medicines, including complex formulations making use of advanced drug delivery technology, and lead analytical development of new medicinal products, primarily parenteral and oral solid dosage forms.
With a global company that believes in helping its people both personally and professionally, this is your opportunity to play a key role in delivering medicines that have a direct impact on patients’ lives. You will be working cross functionally with multiple internal and external interfaces including: Regulatory Agencies, Contract Manufacturing Organisations (CMOs), Formulation Development, Biopharmaceutics, Chemical Development, Commercial Stability, Regulatory CMC, Quality Assurance, Development and Commercial Manufacture and Supply Chain. You will act as a key technical leader helping to deliver, from the early clinical phase through to commercial filings, to global markets in a highly regulated environment.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energised and rewarded for their ideas and creativity.
The Macclesfield Campus, located on the edge of the Peak District in the North West of England, is home to a number of AstraZeneca teams focussed on commercial manufacturing and development. It is the largest AstraZeneca PT&D site globally and you will be joining a vibrant community of scientists and engineers with diverse skills and backgrounds.
As a Senior Scientist - Analytical, your main responsibilities will involve:
Leading analytical activities to support project progression during the clinical and commercial development phases, leading to the registration of new medicines
Keeping a strong focus on quality for our patients
Identifying and solving potential analytical project issues.
Working on either a single key project, or a range of smaller projects
The development of analytical control strategies for new medicinal products
Authoring the CMC components of regulatory submissions and preparation of successful query responses.
The analytical development of other scientists
As a Senior Scientist - Analytical, it’s essential that you have:
Experience of delivering CMC content or contributions to regulatory filings throughout the clinical development phase, including commercial filings, for process analytical aspects of drug product in the pharmaceutical industry
Demonstrated scientific leadership through an understanding of key analytical techniques.
Used knowledge to assess options available and delivered robust scientific contributions to projects.
Knowledge and experience of implementing control strategies (quality by design or equivalent) to define the long-term requirements for ensuring the quality of drug products
Knowledge, and practical experience, of approaches to technology transfers (TT), validation and ICH requirements
Excellent communication and stakeholder skills, and the ability to discuss complex ideas in a simple, easy to understand way
A strong BSc, MSc, or the equivalent in Chemistry or Analytical Chemistry, or a PhD with significant Analytical or Organic Chemistry content
Knowledge of GMP and health and safety requirements
Experience of leading analytical project work
The following skills and qualifications are desirable to deliver the role:
A proven record in a pharmaceutical or similar research/manufacturing industry
Strong problem-solving skills
Experience of at least two phases of drug development
Collaborative working – within team / project / function and with outsourcing partners
The ability to confidently and successfully lead improvement projects
Strong influencing skills and prioritisation skills to ensure project delivery
Demonstrated success in utilising risk based approaches for a successful project delivery and keeping a strong focus on quality for our patients
AstraZeneca welcomes applications from all sections of the community.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability.