Senior Scientist – Process Analytical Technology, Chemical Development
Macclesfield, UK
Competitive Salary & Benefits
Make a more meaningful impact to patients’ lives around the globe
Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
Pharmaceutical Technology and Development (PT&D) are the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.
We have an exciting opportunity for an enthusiastic, highly motivated, Process Analytical Technology (PAT) Scientist to join the Chemical Development Group, part of Pharmaceutical Technology & Development, based at Macclesfield, Cheshire.
Chemical Development is responsible for designing and developing synthetic routes for the manufacture of active pharmaceutical ingredients for candidate drugs and established medicines, ensuring processes can be scaled safely from lab to plant with a focus on robustness, consistency and commercial viability.
As an experienced PAT scientist with a proven track record of delivering at line and on line analytical technology to pharmaceutical development projects, you will be responsible for leading the use of PAT as an enhanced control strategy solution across AZ projects including collaborating with the project scientists and regulatory colleagues to deliver technical elements to our commercial and clinical submissions as required. In this role you will provide PAT leadership into pharmaceutical development delivery teams mentoring less experienced scientists to deliver the Chemistry and Manufacturing Controls (CMC) aspects for projects to meet development timelines. The role will involve working collaboratively with process chemists, engineers, project managers, quality assurance and external partners to achieve a successful delivery.
In addition, you will work across early and late stage Chemical Development activities and support commercial products. You will work collaboratively within multiskilled groups including analytical, chemistry, kinetics, crystallisation, engineering, flow chemistry and new drug modalities, including oligonucleotides. The role will be primarily laboratory-based but with a significant amount of off-line multivariate analysis.
Typical responsibilities include:
To lead PAT solutions to complex projects from phase 2b/3 to commercial within analytical skill area and to bring outward facing perspectives in addressing opportunities (interface departments, specialist capabilities, external to AZ)
To provide expert challenge to drug projects and role model positive behaviours in exploring new ways of working and scientific development
To provide scientific/technical leadership in PAT,, solving problems, identifying learning to share across the department and deliver regulatory submissions
To demonstrate scientific leadership and strategic development of PAT on drug projects, representing Chemical Development as required
To contribute to the delivery of CMC content or contributions to regulatory filings throughout the clinical development phase and commercial filings and preparation of successful query responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements
To deliver the validation requirements for commercial submissions
Contributing to the development of Chemical Development to support AZ current and future portfolio, defining, and delivering continuous improvement plans
All these activities will have a significant impact on the speed, quality and cost of the AZ commercial portfolio, the overall success of the Supply Chain as well as ensuring the commercial viability of the medicine. The role, therefore, has a significant impact on both financial and reputational aspects of the business.
Profile:
BSc/PhD level education in a relevant discipline with experience working within a Research & Development and Manufacturing environment, within the pharmaceutical industry
A strong understanding and proven track record of the development and delivery of drug substance control strategies using PAT for clinical and commercial submissions according to the AZ drug development process
Experience of technical supervision, coaching and mentoring
A significant practical experience and expertise in the Major PAT techniques one or more key analytical areas (e.g. NIR, Raman, IR, UV, LC) to provide expert advice to project teams
A strong data centric mindset with proven ability in the area of Chemometrics
A thorough understanding of the principles and management of SHE and cGMP
So what's next?
Apply with your CV and Covering Letter, detailing you suitability and motivations in applying for the role. We're looking forward to hearing from you!
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.
Date Posted: 10.03.23
Close Date: 02.04.23
Date Posted
27-Mar-2023Closing Date
02-Apr-2023AstraZeneca 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.