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AstraZeneca Pharmaceuticals LP
,
Macclesfield, Cheshire
Associate Principal Scientist - Process Analytical Technologies
Overview
Job Description
Description The role holder will contribute to the Chemical Development department in Pharmaceutical Technology and Development by applying their technical expertise to the development and utilization of Process Analytical Technologies (PAT), including training, capital, external & internal collaborations and new technology introduction. Responsibilities cover all aspects of PAT but with a strong focus on the use of PAT during clinical & commercial manufacturing and for supporting AstraZeneca's exciting new development platforms in continuous processing and oligonucleotide synthesis. You will have a significant impact on the speed, quality and cost of the AZ development portfolio, the overall success of Chemical Development as well as ensuring the commercial viability of the medicine. Accountabilities/Responsibilities + To develop, lead and implement a strategy for PAT within Chemical Development and its clinical manufacturing assets + To provide effective PAT expertise to Chemical Development and, where appropriate, wider in AZ. + Working with external organisations and companies to assess and develop new technologies and ways of working that will improve the development process. + Working and representing Chemical Development on Science and Technology teams. + Delivering technical updates including resource and capital requirements to Leadership teams to ensure progress towards technical area goals are understood + Working with and developing existing user groups, mentoring and developing them in reaching their full potential. + To provide technical supervision to Chemical Development staff on PAT + To work with Global External Sourcing, On-Market and Commercial Operations on the development of PAT in AZ/third-party contractors + To ensure that use of PAT in projects is proactively assessed, prioritised and delivered + To present PAT work in patents, publications and lectures. + To develop and implement, within budget constraints, resourcing and equipment purchasing proposals for the development of PAT in AZ. + No direct reports + No direct budgetary responsibility Conduct activities and interactions consistent with what we value and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance! Education, Qualifications, Skills and Experience Essential + BSc/PhD level education in a relevant discipline and a significant number of years' experience working within a Research & Development or Manufacturing environment, within the pharmaceutical industry. + An externally recognised specialist in one or more elements of PAT with a strong background in chemometric methodologies. + Ability to think and operate across functional boundaries, challenge the status quo and seek opportunities for business improvement. + A good understanding of the overall drug development process from discovery through to launch. + Excellent communication and strategic influencing skills across interfaces of discipline, culture, and expertise both internally and externally. + Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects. + Have a good understanding of principles and application of SHE and cGMP. + Validated problem solver with in depth technical skills. + Demonstrate a high degree of personal credibility. + A consistent track record in embedding new technologies to improve ways of working across an area of drug development. + Have sufficient understanding in the disciplines in Chemical Development and Pharmaceutical Development in order to contribute to an extraordinary Chemical Development organization. + Has or will develop excellent working relationships within Pharmaceutical Development i.e. Product Development, Portfolio and Projects Management, and Supply Chain. Desirable + Has or will develop excellent working relationships outside Pharmaceutical Development including Operations and Regulatory Affairs. + Working knowledge of technical support areas such as reaction kinetics, distillation, crystallisation and drying + Experience of working with academics and other external organizations + Expert and skilled at facilitation at all levels. + An understanding of other key analytical techniques such as separation science, NMR and mass spectrometry.