Associate Principal Scientist (ADC Linker-Payloads) - Analytical

Associate Principal Scientist (ADC Linker-Payloads) - Analytical

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)

The person we are looking for will have a strong background in Analytical Chemistry with hands-on experience of analytical development and generation of drug substance quality control strategies gained in a Chemical Process Development Department. This includes broad experience of analytical aspects of drug substance manufacture on kilo-lab, pilot plant or commercial manufacturing scale. You will be familiar with the latest techniques in Analytical Chemistry in a Pharmaceutical Development Environment utilised for chemical process and material quality control, including Process Analytical Technology. In your career to date you will have also gained an awareness of the analytical chemistry capabilities of leading CDMOs operating in the Drug Substance Sector and will have prior experience of working with, or working at, these organisations.

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

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

Typical Accountabilities

• Will help define and lead implementation of strategic aspects of ECD’s outsourcing activities
• Identifies issues and gaps in CDMO capabilities and works with CDMO partners to resolve these.
• Ability to lead technically complex and accelerated early phase Chemical Development projects.
• Clearly defines the technical scope of outsourced analytical work, leads technical transfer to the CDMO and supervising progress against technical objectives
• Input into the review of proposals and selection of CDMO partners to carry out development and manufacture.
• Defines and implements strategies for efficient delivery of drug substance clearance analysis, stability and release activities across CDMO partners and AstraZeneca.
• Mentorship and input into troubleshooting issues that occur at partner companies.
• Evaluation of the technical performance of CDMO partners, and ability to deliver clear constructive feedback.
• Analytical Chemistry Lead of multiple outsourced projects in cross-functional Pharmaceutical Sciences CMC Project Teams – responsible for communication and management of risks, issues and opportunities to the wider project team
• Leads the development of an analytical strategy that spans Drug Substance and Drug Product.
• Leads delivery of drug substance analytical Chemistry and Manufacturing Control (CMC) contributions to regulatory filings throughout the early clinical development phase (Ph1 to Ph2b), applying sound knowledge of regulatory guidelines and other territorial requirements.
• Maintains oversight of assigned outsourced projects from a regulatory perspective and management of regulatory change control.
• Act as channel for input of AZ specialist expertise (e.g. Separation Science, Stability, Microbiology) into projects executed remotely.
• Applies knowledge acquired from work with specific CDMO partners back into internal AstraZeneca projects and to projects at other CDMOs
• Provides leadership in development of approaches to analytical data and knowledge management

Qualifications, Skills and Experience

Essential

• A degree (BSc, MSc or equivalent) in Chemistry or Analytical Chemistry with a sound knowledge of synthetic organic chemistry
• A proven track record of analytical development in a pharmaceutical environment and project leadership and delivery.
• Significant industrial experience (> 5 years) in Chemical Process Research and Development at a Pharmaceutical Company or Pharmaceutical Sciences CDMO.
• The ability to expertly and successfully lead improvement projects.
• Excellent communication and influencing skills and demonstrated ability to work in multi-functional project teams
• Detailed knowledge of cGMP
• Detailed knowledge of ICH guidelines and their application to Pharmaceutical Drug Substance and Drug Product.
• Understanding of key analytical techniques, including NMR, chromatography and mass spectrometry and their application to knowledge acquisition and analytical control within drug substance manufacturing processes

Desirable

• Experience of working with Early Drug Development Projects (Pre-Clinical to end of Phase 2b)
• Project Management Qualification e.g. APM PMQ or PRINCE2 practitioner or significant experience in managing complex outsourced projects
• Prior experience of authoring Regulatory Submissions (Drug Substance modules)
• Experience of leading cross-functional teams.
• Previous experience of working with China-based organisations and knowledge of the Mandarin Chinese language would be an advantage
• Experience of mentoring and people development

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Welcome with your application; CV and cover letter, no later than 1st June 2023

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. 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.