Associate Principal Scientist (ADC Linker-Payloads) - Chemistry

Associate Principal Scientist (ADC Linker-Payloads) - Chemistry

Macclesfield

Salary & Benefits Competitive

Be empowered to be innovative and creative where difference is valued

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

The 101-acre Macclesfield is the biggest pharmaceutical manufacturing site in the UK, supported by over 3,000 employees. The campus is also home to pharmaceutical sciences and is the only AstraZeneca site with chemical development capabilities.

Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.

We have an exciting opportunity to join our Early Chemical Development Team as a Lead Technical Outsourcing Manager in our new modality team! Where you will work with internal and external teams to deliver innovative synthetic routes and processes to Antibody Drug Conjugate (ADC) linker-payloads to drive our Early Phase development projects.

The Function - Pharmaceutical Sciences

Pharmaceutical Sciences is a function within the AstraZeneca’s Biopharmaceuticals R&D unit that creates innovative, efficient solutions by transforming molecules into investigative medicines meeting unmet needs of future patients. The function has five departments: Early Chemical Development, Advanced Drug Delivery, Early Product Development, Project Management and Manufacturing, and Data Science and Modelling. Our multifaceted portfolio of projects includes traditional small molecules, nucleotide-based therapies and nano-medicines across AstraZeneca’s therapy areas.

The Department – Early Chemical Development

Early Chemical Development (ECD) is a World-Class CMC department with responsibility for early phase Drug Substance. The department’s responsibilities span from early engagement with Discovery Chemistry groups to manufacture of Phase II Clinical material, and its key skill areas include Analytical Chemistry, Crystallisation, Isotope Chemistry, Large-Scale Laboratory (Kilo-Lab) Manufacturing, Process Chemistry, Process Engineering and Separation Science.

In addition to its in-house activities, ECD partners with several of the world’s leading Contract Development and Manufacturing Organisations (CDMOs) in order to effectively deliver our rich and exciting pipeline of New Molecular Entities. As a result of recent growth of our portfolio, we are seeking to expand our team of New Modality Technical Outsourcing Managers.

The Role – Lead Technical Outsourcing Manager (ADC linker-payloads)

As an experienced Process Chemist with a proven track record of delivering pharmaceutical development projects in collaboration with CDMO partners, you will be responsible for leading the supply strategy and scientific input to support external development and manufacture of several of our linker-payloads for use across AZ’s ADC portfolio.

The person we are looking for will have a strong background in Process Chemistry with hands-on experience of laboratory process development of small molecules and the transfer of processes into manufacturing facilities. You will be familiar with the newest technology in Chemical Development including Continuous Processing, Bio-catalysis and Process Analytical Technology. In your career to date you will have also gained an awareness of the capabilities of leading worldwide CDMOs operating in the Drug Substance Sector and will have prior experience of working with, or working at, these organisations. We particularly welcome applicants with experience of transitioning projects from Medicinal Chemistry into Chemical Development.

You will be a confident communicator with a proven track record to influence across cultures and geographies.

What you’ll do

• To define and lead implementation of strategic aspects of ECD’s outsourcing activities for linker-payloads.

• Identification, evaluation, selection and onboarding of new suppliers (in collaboration with Sourcing and Procurement colleagues)
• Lead technically complex and accelerated early phase Chemical Development projects.

• Clear definition of the technical scope of outsourced work (Route and/or Process Design, Development and Manufacture) and supervising progress against technical objectives
• Input into the review of proposals and selection of CDMO partners to carry out development and manufacture.
• Mentorship and input into solving issues that occur at partner companies.
• Evaluation of the technical performance of CDMO partners, and ability to deliver clear constructive feedback.

• Act as channel for input of AZ specialist expertise (Catalysis, Crystallisation, Process Engineering, Bio-transformations, Computational Chemistry, Process Safety and Continuous Processing) into projects driven remotely.

• Authorship of regulatory modules for IMPD/IND drug substance – ability to maintain oversight of assigned outsourced projects from a regulatory perspective and management of regulatory change control.

Essential Criteria

• Graduate or Post-Graduate Degree in Chemistry with a sound knowledge of Synthetic Organic Chemistry including significant practical experience in the laboratory.
• Significant industrial experience in Chemical Process Research and Development at a Pharmaceutical Company or Pharmaceutical Sciences CDMO.
• Excellent interpersonal skills and demonstrated ability to work in multi-functional project teams
• Experience of transfer of laboratory processes to manufacturing facilities.
• Detailed knowledge of cGMP

• Understanding of patent and Intellectual Property strategies

Desirable Criteria

• Experience of working at the interface of Medicinal Chemistry with Process Chemistry
• Experience of working with Early Drug Development Projects (Pre-Clinical to Phase 2b)
• Appreciation of Sustainability measures for Chemical Processes
• Prior experience of manufacturing in a high containment facility
• Project Management Qualification e.g. APM PMQ or PRINCE2 practitioner or significant experience in leading complex outsourced projects
• Prior experience of authoring Regulatory Submissions (Drug Substance modules)

Why AstraZeneca

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.

So, what’s next?

Complete your application before the below closing date.

This role is open from 17/05/2023. We welcome your application no later than 31/05/2023

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Please note that 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.