Senior Scientist Sterile Manufacturing Product Development

Job Description

Senior Scientist:Sterile Manufacturing (Product Development)Macclesfield, UK At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to address the unmet needs of patients around the world. We focus on those areas where we believe we can really change the course of medicine and bring new ideas to life.As a Senior Scientist youll apply your expertise to help us deliver great medicines, develop your technical and interpersonal skills and gain a breadth of insight into the business!We are a major international healthcare player engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we’re more than one of the world’s leading pharmaceutical companies, we’re proud to have a rare workplace culture that inspires innovation and collaboration. Here, you are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for your ideas and creativity.Pharmaceutical Technology and Development (PT&D) utilises great science delivered by great people to develop medicines that help millions of patients worldwide. As we adapt to the exciting challenges of our portfolio we have recently built the New Modalities and Parenteral Development (NMPD) organisation to further focus our late stage development activities. Were now looking to recruit a motivated Senior Scientist on a permanent basis into NMPD, working as part of multi-disciplinary teams across early to late stage formulation and process development and specialising in the area of sterile manufacturing.Based in Macclesfield, Cheshire, with easy access to Manchester and the Peak District and fast trains to London and Birmingham, this is a location with something for everybody.The Senior Scientist is responsible for delivering key process understanding and impactful lab capability in the lyophilisation and/or terminal sterilisation areas, critical technologies that are needed to deliver the next generation of medicines to patients. This will build our product understanding and progress the development of life-changing medicines within a dynamic environment. You will be a key member of a diverse team and responsible for delivering high quality scientific activities within your specialism to meet project timelines, working collaboratively to achieve successful delivery of goals. What youll do Rational design and delivery of experiments that enable development of high quality drug products to support clinical and commercial supply and meet patient needs. Ensuring development of robust sterile manufacturing processes through support of their control strategies, marketing applications and downstream commercialization activities, e.g. scale up from lab to pilot, clinical and commercial scale, technology transfer and ongoing technical support post-launch. Working optimally with colleagues across Product Development, Pharmaceutical Sciences and Operations to ensure the successful delivery of drug projects spanning all phases of development. Authoring of regulatory documentation to support clinical trial and marketing applications. Collaborative work within the formulation, materials science and process engineering networks to develop science and technology strategies and deliver capability build.You will also provide technical supervision and mentoring to peers and students. Drive innovation, securing intellectual property and enhancing AstraZeneca’s scientific reputation by publishing high calibre research and engaging in external collaborations. Essential for the role

Relevant industrial experience in a clinical or commercial sterile product manufacturing environment, with a degree in an appropriate scientific area related to drug development

A strong scientific background in delivering creative and robust pharmaceutical manufacturing processes during the development of sterile drug products, including solutions and lyophiles

Good knowledge of how drug product properties influence manufacturing process design, and manufacturing processes impact final drug product quality

Strong collaborative working and communication skills - able to work effectively with colleagues from diverse backgrounds and different skill areas. Ability to work safely and follow key quality systems to ensure data integrity

Desirable for the role

Experience in development, scale up and technology transfer of sterile parenteral manufacturing processes including sterilisation method selection, single-use technology and lyophilisation

Knowledge and experience of working to Good Manufacturing Practice (GMP). Experience of working with, and managing relationships with, external suppliers. Specialised knowledge of the theory of parenteral product sterilisation and/or lyophilisation

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested Come and join our journey.Please include your CV and a covering letter in your application.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.