Associate Director – Chemical Development (Process Chemistry)
Location: Cheshire East
Job Type: Full time
Associate Director – Chemical Development (Process Chemistry)
Competitive Salary & Benefits
Date Posted: 24th January 20
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We have an exciting opportunity for an Associate Director in Process Chemistry! You will lead a vibrant team of process chemists in order to drive development projects and deliver innovative synthetic organic chemistry solutions.
The Department - Chemical Development
In Chemical Development, we help turn molecules into medicines. 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 Director (Process Chemistry)
As an experienced process chemist with a proven track record of delivering pharmaceutical development projects, you will lead a team of process chemists delivering projects from across our portfolio, responsible for:
Developing sustainable chemical routes and chemical processes for drug substance based on comprehensive process understanding.
Developing and implementing sustainability (with low carbon footprint) into drug substance manufacturing processes.
In conjunction with other skill groups develop overall control strategies to ensure appropriate quality and robustness of clinical and commercial products according to current regulatory guidance.
Supporting manufacturing activities to supply materials for clinical studies.
Technology Transfer of manufacturing methods.
Authoring and reviewing of CMC documentation for clinical and marketing AstraZeneca product submissions.
Identification and exploitation of innovative science, cutting edge technology and future capabilities to improve drug substance manufacturing processes.
Securing Intellectual Property and freedom to operate.
Act as a source of expert guidance in the above areas for the chemistry skill group in chemical development.
All these activities will have a significant impact on the speed, quality and cost of the AstraZeneca development portfolio and the overall success of PT&D, as well as ensuring the commercial viability of the medicine.
Key responsibilities include:
Being a leader in delivering development projects, or a portfolio of projects, from phase 2b/3 to commercial, and to drive cross-functional collaboration.
Mentoring direct reports and others for enhanced individual and team performance on an ongoing basis.
Ensuring delivery of SHE and cGMP compliance, ensuring that all work is carried out with due regard to AstraZeneca and external regulatory policies and standards.
Setting the strategy and ensures the optimal delivery of the project portfolio within their area of responsibility.
Identifying and solving potential issues and acting as an interface between departments.
Ensuring work within own project, and those outside of the team, meets required standards.
To provide expert challenge to drug projects and exemplify positive behaviours in exploring new ways of working and scientific development, including external perspectives
To deliver 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.
To act, as appropriate, as an authorised person accountable for the approval of documentation.
Building and maintaining strong, collaborative relationships with Operations, Regulatory, Projects and Portfolio Management, Pharmaceutical Science, Supply Chain, at an operational level.
Enhancing the external reputation of the company by representing AstraZeneca: through external presentations, publications, working parties and academic collaborations.
BSc, MSc or PhD level education in a relevant organic chemistry discipline with substantial experience in the pharmaceutical industry, ideally in Chemical Development.
Experience of technical supervision, coaching and mentoring, or leading teams of people to deliver scientific projects.
A good understanding of the overall drug development process from discovery through to launch.
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.
An established scientific reputation, e.g. publications in peer-reviewed journals, patents, talks at international conferences, etc.
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: 12th February 2023
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
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.