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Associate Director, New Modalities Process Chemistry
2 weeks ago
**Associate Director, New Modalities Process Chemistry***
**Location: Macclesfield**
**Competitive salary and Benefits**
**Hybrid working 3 days a week in the office**
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
The Role - Associate Director, New Modalities 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 New Modality API portfolio responsible for:
- Developing effective synthetic routes and manufacturing processes for drug substance that deliver the right quality, meet Cost of Goods targets, and minimise our environmental impact (_e.g. _process mass intensity, carbon footprint) based on comprehensive process understanding
- Identification and exploitation of innovative science, cutting edge technology and future capabilities to improve 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 to internal and external manufacturing organisations
- Authoring and reviewing of CMC documentation for clinical and marketing AstraZeneca product submissions
- 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 activities aligned to these areas will have a significant impact on the speed, quality and cost of the AZ development portfolio, the overall success of PT&D as well as ensuring the commercial viability of the medicine.
**Key Accountabilities**
- Line management of a team of 8 to 10 process chemists, including performance management. Coaching direct reports and others for enhanced individual and team performance on an ongoing basis, driving technical excellence and supporting individual development
- Ensuring delivery of SHE and cGMP compliance, and that all work is carried out with regard to AstraZeneca and external regulatory policies and standards.
- To act, as appropriate, as an authorised person accountable for the approval of documentation
- Setting the strategy and ensuring the optimal delivery of the team’s project portfolio, driving technical standards and cross-functional collaboration. Providing expert challenge to drug projects and driving exploration of new ways of working, including external perspectives
- Building strong, collaborative relationships with Operations, Regulatory, Projects and Portfolio Management, Pharmaceutical Sciences, Supply Chain, at an operational level
- Enhancing the reputation of the company by representing AstraZeneca: through external presentations, publications, working parties and academic collaborations
**Required Skills, Knowledge & Experience**
- BSc, MSc or PhD level education in a relevant organic chemistry discipline with substantial experience in the pharmaceutical industry, ideally in API process development
- Experience of technical supervision, coaching and mentoring, or leading teams of people to deliver scientific projects
- Experience of delivering New Modality API projects (_e.g. _Oligonucleotide, Peptide, Antibody Drug Conjugate) and understanding of the associated key chemistry technologies is highly desirable
- A good understanding of the overall drug development process from discovery through to Launch with an appreciation of how Pharmaceutical Technology & Development contributes to R&D and the broader business
- Experience of delivering CMC content or contributions to regulatory filings throughout the life cycle of process development, in the pharmaceutical industry
- A thorough understanding of the principles and management of SHE and cGMP
- An established scientific reputation, _e.g._ publications in peer-reviewed journals, patents, talks at international conferences, etc.
- Excellent communication and strategic influencing skills across interfaces of discipline, culture, and expertise both internally and externally
- Ability to solve problems, analyse and interpret complex situations, and provide clear strategic direction
