Senior Engineer - Process Engineering & Packaging

ASTRAZENECA UK LIMITED, Newtown, Cambridge

Senior Engineer - Process Engineering & Packaging

Salary Not Specified

ASTRAZENECA UK LIMITED, Newtown, Cambridge

  • Full time
  • Permanent
  • Onsite working

Posted 2 weeks ago, 7 Jul | Get your application in now before you miss out!

Closing date: Closing date not specified

job Ref: d9bd6366c5674544848002f0ffd14b21

Full Job Description

This role reports into the Process Engineering and Packaging (PEP) team for drug product process development within the Biopharmaceutical Development (BPD) function in AstraZeneca. The PEP team has accountability for drug product process development, process characterisation, combination product assembly development, and packaging science and technology across a broad range of biotech product types and technologies. We support the entire portfolio from Phase 1 clinical trial materials through to marketing application and product launch., + Develop drug product manufacturing processes for vial, prefilled syringe and cartridge product + Perform process risk assessments such as FMEA, design characterisation and engineering studies, develop control strategies, author protocols, technical reports and regulatory filing sections + Specify requirements of manufacturing equipment and support equipment design and build + Provide technical rigor in design for manufacturing, experimental design, data analysis, and technical writing + Develop R&D laboratory process capabilities

  • Technology Transfer and Process Validation
  • + Lead technology transfers to contract manufacturing organisations (CMOs) and internal manufacturing facilities for clinical and late-stage projects + Coordinate an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA + Ensure accurate implementation of control strategies for the drug product and device into manufacturing records + Design and lead all aspects of validation activities for equipment, manufacturing processes, and shipping. Lead timelines and activities internally, communicate goals and be responsible for successful delivery at the receiving site + Some travel in the EU and abroad is required in support of technology transfer
  • Technical Leadership
  • + Supply critical thinking to drug and combination product development teams by providing knowledgeable advice on design for manufacturing, equipment vendor selection, manufacturing site selection / alternatives, project lead time and budget estimates + Advise functions and teams on new manufacturing technology selection and development + Develop risk-based characterization and validation strategies for manufacturing processes

  • Relevant technical degree (BSc, MSc, PhD, EngD) in Biochemical, chemical, or pharmaceutical engineering, or a related engineering or pharmaceutical science field.
  • Experience in Biopharmaceutical drug product development for monoclonal antibodies and recombinant proteins.
  • Experience of leading and delivering technology transfer of fill-finish processes.
  • Knowledge of formulation and fill-finish unit operations such as freeze-thaw, formulation, filtration, mixing, and aseptic filling.
  • Understanding and experience applying Quality by Design (QbD), experimental design and statistical data analysis.
  • Strong communication, influencing and relationship building skills with AZ customers, peers and third party suppliers.
  • Ability to develop and nurture innovation opportunities and lead any changes.
  • Desirable Requirements:
  • Knowledge of combination product development and cGMP regulations.
  • Knowledge of equipment, process and shipping validation.
  • Ability to work in diverse multinational teams.
  • Good awareness and understanding of current primary container and fill-finish technologies and the lifecycle approach to validation.
  • So, what's next? Are you already envisioning yourself joining us? Good, because we can't wait to hear from you!

    At AstraZeneca, we harness the power of science to transform healthcare. Our mission is to treat, prevent, and cure complex diseases through innovation and collaboration. Join a team that thrives on creativity and science-led decisions, continuously exploring new frontiers in medicine. With a commitment to cutting-edge technologies and smart risks, we are shaping the future of healthcare, one breakthrough at a time. As part of our diverse and inclusive culture, you'll contribute to meaningful work that reaches billions of patients globally. If you're driven by passion and purpose, join us at AstraZeneca and make a difference.

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