Scientist Senior Scientist Bioassay

Introduction to role::

Are you a Scientist with well founded in vitro assay development experience who wants to add large pharma industry experience to your portfolio

Are you fuelled by the commitment to help patients and see what science can do

An opportunity has arisen to be a part of the Bioassay Biosafety and Impurities Group (BB&I) accountable for developing state-of-the-art methods to evaluate product quality by measuring biological activity and detecting characterizing and quantifying product variants and process-related impurities for biologics (e.g. antibodies and antibody like (incl.multispecifics antibody drug conjugates engagers modified peptides etc)). This enables product understanding manufacturing process development formulation drug productdevelopmentand regulatory filings to bring our drugs to the clinic and eventually onto the addition this group is accountable for control systems including specifications comparability and shelf-life strategies required by regulatory agencies. Also it performs technical transfer of methods to clinical quality control and commercial launch sites and technical support and lifecycle management post-launch.

We areseekinga motivatedlabbasedscientist with strong scientific judgment proven experience ininvitrobiological activity assays (bioassays) and a clear drive to embedemerging physical automation and AI-driven analysis toolsinto daily workflows. Based at the Discovery Centre Cambridge the successful candidate will behandsonin developing and implementing novelcellbasedand immunoassays.

Our Expectations:

• Use your knowledge of cell culture and hands-on potency assay development in a team-oriented environment.

• Support our drug development programmes with data effectively utilising existing and novel technologies and instrumentation.

• Convert opportunities and resources to succeed and thrive around the team and communicate achievements to different audiences including team meetings global groupmeetingsand matrix teams.

• Learn from experience and guidelines/documentation to increase responsibilities and complexity of tasks to be performed with a higher level of autonomy.

• Motivated by curiosity and a solid scientific foundation to learn and train others in utilisingnew technologiesand automation-friendly approaches.

• Build on AZs science driven dynamic environment.

Accountabilities:

• Develop biochemical and cell-based potency assays based on drug mode of action and carry out routine sample testingfor large molecules in AZs pipelineina timelyfashion.

• Enable transfer of any methods to other groups as appropriate.

• Accurately record all data clearly and concisely with a clear understanding of its implications within the overall context of drug development.

• Manage own work to ensure that agreed targets are met and to agreed quality standards communicating progress appropriately.

• Discuss and defend experimental findings at cross-functional meetingsrepresentingtheBioassayBiosafetyand Impurities Groupin CMC teams present in internal symposia and external conferences.

• Prepare for review clear and concise technical documents like SOPs work plans workreportsand instructional documents.

• Work alongside team members/automation engineers to bridge manual experimental and data analysis protocols into structured automation ready workflows.

• Assistin the training& coachingof others in procedures and practices.

• Ensure that work is performedin accordance withappropriate Safety Health & Environment (SHE)qualityand compliance standards.

Essential Skills:

• For Senior Scientist -PhD with2-6yrs of experience(or equivalentrelevantscientific experience).

• For Scientist MSc with2-6yrsexperience (orequivalent relevant scientific experience).

• Thorough understanding ofimmunoassay/binding assays.

• Thorough understanding of mammalian cell culture and hands-on experience with in vitro cell-based assay techniques and their applications e.g. cellular signalling receptor binding assays reporter assays proliferation assays cytotoxicity ELISA MSD HTRFAlphaLISASPRimaging assaysand flow cytometry.

Desired Skills:

• Drug development experience in academia Pharma/Biotech industry.

• Experience withADCC/CDC/ADCP assaysandBioassay/CMC.

• Experience with cell line generation and molecular biology techniques.

• Experience withliquid handlerse.gIntegra Assist Dragonfly Hamiltonetc.

• Experience with data analysis softwares like GraphPad Prism JMP SoftMax Pro etc.