Associate Principal Scientist - Formulation Project Expert
Location: Cheshire East
Job Type: Full time
In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
In New Modalities and Parenteral Development (NMPD) at Macclesfield, we focus on the design and development of commercial products and processes, contribute to new product introductions and build the capabilities required to develop the products of the future. You will join a vibrant team that is working on the next generation of medicines and play a key role in the development of new medicinal products.
As an Associate Principal Scientist in Formulation, collaborating across the Pharmaceutics area, you will be responsible for coordinating, leading and delivering late-stage parenteral drug product development projects. Building product, control strategy and regulatory understanding to progress the development of both traditional small molecule and new modalities (e.g. oligonucleotides, peptides/proteins, dendrimers, mRNA) within a dynamic team environment will be your key focus. To deliver these goals, you will work collaboratively across boundaries with colleagues from other scientific teams in AstraZeneca (analysts, engineers, microbiologists, device experts etc.) as well as other functions (clinical, supply chain, regulatory, etc.)
What you'll do:
Pharmaceutics drug product lead on PT&D pharmaceutical teams for complex or multiple projects, representing NMPD at cross functional boundaries.
Driving and owning project plans and strategies including; timelines, risk management, resource cost estimates and control strategies to meet the wider project aims and deliverables.
Working effectively with colleagues across Operations and leading local delivery teams composed of skill area representatives to ensure the successful delivery of drug projects spanning all phases of development.
Authoring of regulatory documentation to support clinical trial and marketing applications, ensuring continued and safe access of our products to patients. Taking the lead in regulatory strategy, response to questions and interactions as required.
Providing leadership in the global formulation capability network and coaching to other formulation scientists and project leads within the department, supporting their development in order to build capability essential to the delivery of the present and future project portfolio.
Demonstrating creativity and innovation, creating, driving and supporting a culture of scientific excellence in projects.
Required Skills & Knowledge
Significant post-graduate industrial experience in formulation of parenteral drug products (i.e injectables), or a PhD in pharmaceutics or drug delivery.
Experience and thorough understanding of the overall development and commercialisation process of drug products from development, launch and ideally through life-cycle management.
Proven track record of delivering multiple and/or complex late stage parenteral drug product development projects.
Significant experience in clinical and commercial regulatory authoring, response to questions and leading other regulatory interactions.
Experience in development of product control strategies, bringing together different aspects of pharmaceutical and analytical sciences.
Strong collaborative working and communication skills, including ability to work effectively with colleagues from diverse backgrounds and different skill areas.
Good organisational and planning skills with the ability to deliver to agreed time and quality.
Preferred Skills & Knowledge
- Experience of new modalities and their challenges in terms of control strategies and regulatory strategy, including combination products.
- Experience of working with external suppliers and managing productive relationships.
Knowledge and industrial experience of pharmaceutical development in a sterile GMP environment
There are so many fantastic employee benefits that AstraZeneca offer! AstraZeneca can offer you a competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.
Interested…..come and join our journey!
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 authorization and employment eligibility verification requirements.