Impact on business results
- Be a part of the project team to participate in analytical method development and validation to support formulation and manufacturing process development activities.
- Manage Global and China stability programs for the project as assigned by the technical lead. This would include writing and/or approving stability protocols, interpretation of data and subsequent regulatory specification setting.
- Under the guidance of the technical lead, author part of the Drug Product sections for CMC dossier submissions, suitable for Global and China submission.
- Participate in method establishment at AstraZeneca Clinical or Commercial Operations facilities.
- The role holder will have sufficient experience to work relatively independently on packages of work assigned by the technical lead.
- To provide scientific or technical supervision to junior members of the team, particularly placement students, within AstraZeneca to enable them to optimally meet their project objectives.
- To actively participate in non-project scientific work and present work through patents, publications and lectures.
- Maintain good knowledge of the external regulatory environment.
- Contribute to constructive scientific debate during project technical reviews.
People Management, Problem Solving, Communication
The role holder will:
- Take responsibility for the quality, communication and delivery of science in projects.
- Will be prepared to step up and deputise the technical lead to represent the CMC team in the core project teams supporting Global development activities.
- Identify improvements in science and technologies that can be successfully applied to advance department activities that contribute to achievement of Business goals.
- Recommend, gain commitment to, initiate, lead and champion new science and technology initiatives within the department that improve its capability to deliver on projects.
- Be an active member of scientific discipline networks.
- Demonstrate creativity and innovation on projects.
Minimum Requirements – Education and Experience
Functional & Business knowledge
Experience, Functional Knowledge, Business Knowledge, Education, Specialist Skills
- Demonstrated a proven track record of delivery and experience in product development.
- Have a good understanding of the overall drug development process with an appreciation of how CMC development contributes to R&D.
- Significant experience in pharmaceutical science, including demonstrating scientific leadership.
- Evidence of good communication skills and of building good relationships with customers.
- Usually more than 7 years of industrial experience with a B.Sc., more than 5 years with a M.Sc., 0-2 years with a Ph.D.
Internal and External Contacts/Customers
- This role will be working closely with the technical lead on a development project.
- This role will have significant interaction with colleagues in the broader teams in the UK and Sweden, and will be a part of the wider analytical technical network.
- Work in collaboration with line and project managers to ensure that science and technology that is implemented in projects is world class.
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.