Associate Principal Scientist (Process Chemistry)

We are offering an exciting role as an Associate Principal Scientist in Process Chemistry, where you will deliver innovative synthetic organic chemistry solutions and lead vibrant teams of scientists in order to drive development projects

The Company - AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical company where we not only focus on the discovery, development and delivery of life-saving medicines to our patients but believe in sustainability and are determined to minimise the impact of our work on the environment. We are proud to be a great place to work and have a culture that inspires innovation and collaboration. We empower our colleagues to express diverse perspectives and at the same time feel valued, respected and rewarded for their ideas and creativity.

The Department - Chemical Development

In Chemical Development, we combine technical knowledge and understanding with the talent and drive to design, develop and optimise synthetic routes that deliver the active pharmaceutical ingredients (APIs) of our medicines in a scalable, sustainable, commercially viable way. We seek individuals who are determined to push the boundaries of science to deliver medicines to our patients. We believe in innovation and continuous improvement, working closely with colleagues in academia and across industry, to ensure that we apply the newest technologies and principles in the chemical processes we develop.

The Role - Associate Principal Scientist (Process Chemistry)

As an experienced process chemist with a proven track record of delivering pharmaceutical development projects, you will be responsible for leading small groups of development scientists and the technical and regulatory contribution to API delivery. The role holder will provide process chemistry leadership into pharmaceutical development delivery teams, personally develop chemistry as well as direct process chemists to deliver the Chemistry, Manufacturing and Control (CMC) aspects for projects to meet development timelines. You will work collaboratively with analysts, engineers, project managers, quality assurance and external partners to achieve success. The role encompasses some or all of the following key drivers, depending on the stage of clinical development: speed, quality, cost, efficiency, control strategy, robustness and understanding, to ensure quality of API and knowledge of processes for toxicology trials, clinical evaluation and commercialisation.

Key responsibilities include:

• Be a technical leader in development projects, or a portfolio of projects, from phase 2b/3 to commercial within the process chemistry skill area and to promote and drive cross-functional collaboration
• Personally develop and champion innovative syntheses; sustaining your expertise in practical synthetic organic chemistry to provide the right scientific solution within the wider context of the project needs. Role modelling and championing scientific method within your technical team
• Providing expert challenge to drug projects and exemplify positive behaviours in exploring new ways of working and scientific development, including external perspectives
• Providing scientific/technical leadership across the skill groups in resolving risks, identifying learning to share across the department and deliver regulatory submissions
• Demonstrating scientific leadership and strategic development of drug projects, representing Chemical Development on CMC Project and Global Supply Teams.
• Delivering CMC content or contributions to regulatory filings throughout the clinical development phase and commercial filings and preparation of successful responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMA, FDA) and other territorial requirements.
• Coaching and developing colleagues, supporting them in reaching their full potential.
• Identifying and solving potential issues and acting as an interface between departments.
• Contributing to improving the capability of Chemical Development to support the current and future project portfolio, defining and delivering continuous improvement plans.
• Acting, when appropriate, as an authorised person accountable for the approval of documentation

Profile:

• BSc, MSc, MChem or PhD level education in a relevant organic chemistry discipline with a proven level of experience, delivering within mid to late-stage Research & Development in the pharmaceutical industry
• An established scientific reputation, e.g. publications in peer-reviewed journals, patents, talks at international conferences, etc.
• A good understanding of the overall drug development process from discovery through to launch.
• Experience of technical supervision, coaching and mentoring, or leading small teams of people to deliver scientific projects.
• A thorough understanding of the principles and management of SHE and cGMP.
• Experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process development, in the pharmaceutical industry.
• An understanding of key chemistry technologies used in the development and manufacture of API.

Skills and capabilities

• Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement.
• Ability to analyse and interpret complex situations and provide clear strategic direction.
• Excellent communication and strategic influencing skills across interfaces of discipline, culture, and expertise both internally and externally.
• Proven problem solver with in-depth technical skills.
• The ability to confidently and successfully lead improvement projects.
• Experience of supporting clinical and commercial manufacture and working with contract manufacturing organisations.
• Experience across late-phase development (Phase 2b/Phase 3/commercial) with a background in the process chemistry skill group.
• Application of risk-based approaches in project delivery

Please note applications must include your current CV and a covering letter which presents your key areas of strength and why you should be considered for the role.

Closing date: Sunday 19th March 2023

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.

Date Posted

Closing Date

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.