AstraZeneca Pharmaceuticals LP Analytical Senior Scientist in Chemical Development - Operations in Macclesfield, United Kingdom
We are currently looking for analytical pharmaceutical development scientists in Chemical Development with scientific project-based expertise. You will join our Chemical Development (CD) team in Pharmaceutical Technology and Development (PT&D), Macclesfield Campus, UK.
Within this group we transform brilliant science into real medicines that help millions of people. We work across the entire value chain and are dedicated to the development of clinical and commercial active pharmaceutical ingredients (API) across a range of small and large molecules
You will join a vibrant team that is working on the next generation of medicines and play a key role in the analytical development of new medicinal products. We will rely on you to bring a strong analytical perspective to the team across a diverse, multi-skilled area and to support late stage development of drug substances. You will be responsible for delivering analytical knowledge that encompasses understanding of manufacturing processes, control strategy and robustness. You will work independently with the potential to lead a small analytical project team, as well as having regular cross functional interactions with multiple internal and external interfaces including Process Chemists, Engineers, Contract Manufacturing Organisations (CMOs), Product Development, Regulatory CMC, Quality Assurance and Supply Chain.
With a global company that believes in helping its people both personally and professionally, this is your opportunity to deliver medicines that have a direct impact on patients’ lives.
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 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 an Analytical Senior Scientist in Chemical Development 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 analytical project issues
Working on either a single key project, or a number of smaller projects
The development of analytical control strategies for new medicinal products
Authoring the CMC components of regulatory submissions and preparation of successful regulatory responses
The technical development of other scientists
We are looking for candidates with the following qualifications, knowledge and skills:
A BSc, MSc, or equivalent in Chemistry or Analytical Chemistry with experience in an industrial environment, OR a PhD with significant Analytical or Organic Chemistry content
Experience of successfully delivering analytical activities
Knowledge of GMP and health and safety requirements
Knowledge of and practical experience in analytical method development across a range of techniques
Excellent communication and stakeholder skills, and the ability to discuss complex ideas in a simple, easy to understand way
Collaborative working within your team, project, function and with outsourcing partners
Scientific leadership skills and the ability to use knowledge to assess options available and deliver robust scientific contributions to projects
Strong problem-solving skills
The following experience and skills are desirable:
A proven record in a pharmaceutical or similar research/manufacturing industry
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
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
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
Applications should include your current CV and a covering letter, presenting your motivation and suitability for the role.
The application window opens June 2018 and closes 15 July 2018. Applicants will be notified of application outcome in late July/early August 2018.
Apply now to learn more about this exciting opportunity with a world renowned pharmaceutical brand!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law