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Associate Scientist, Process Engineering and Packaging

AstraZeneca
Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Associate Scientist, Process Engineering and Packaging (PEP)Cambridge, UKAt AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us!Job DescriptionIn the Processing Engineering & Packaging role you will be involved in developing manufacturing processes for technology transfer to internal and external manufacturing sites for AstraZeneca biopharmaceutical drug products. The process engineering team works within biopharmaceutical development (part of R&D), alongside early/late stage formulation, device and delivery teams. The position is a hands-on, laboratory-based, role.Primary responsibilities will include:Conduct lab studies supporting the development of formulation, filling, device assembly processes and/or packaging tests for biotechnology drugs and combination products.

  • Perform sample analysis using a wide range of protein and biomolecule characterisation assays (e.g. HPLC, UPLC, HIAC, MFI, cIEF).
  • Make detailed observations and interpret data
  • Write concise and accurate electronic lab notebooks, study protocols and summary reports, and communicate findings to the team in the form of technical presentations.
  • Technical writing responsibilities also include drug product sections in clinical trial applications (IND/IMPD).
  • Support technical transfer of fill-finish processes to CMOs and internal manufacturing facilities for biopharmaceutical drug products
  • Perform risk analyses, write study protocols
  • Co-ordinate testing of samples in development labs from engineering studies conducted at the manufacturing site
  • Support engineering and clinical fills at GMP fill-finish sites as the need arises. Some travel is required (typically 0-5 trips per year within UK, EU or US)
  • Contribute to operation of a fill-finish laboratory with lab-scale capabilities including vial and syringe filling and lyophilisation
  • Performing critical filling operations for drug product stability studies
  • Organisation and maintaining consumables stocks
  • Performing routine upkeep of lab equipment and writing and updating SOPs
  • Co-ordination of lab activities/standard methodology with the wider team
    • Position RequirementsEducation & Experience:
  • BSc or MSc degree in chemical, biochemical, pharmaceutical or mechanical engineering, or a related engineering or pharmaceutical science field
  • Suitable experience may include university laboratory research, pharmaceutical R&D internships or full-time positions, or similar
    • Desirable knowledge and experience
  • Biopharmaceutical drug product development
  • Fill-finish unit operations such as formulation/compounding, mixing, filtration, aseptic filling and lyophilization (freeze-drying)
  • Biopharmaceutical degradation pathways and mechanisms
  • Awareness of cGMP, aseptic processing, and related regulatory literature
  • Quality by Design (QbD), experimental design, statistics, analysis of data
  • Experience participating in multi-functional teams is valuable
    • Desirable skills:
  • Practical lab and technical skills
  • Attention to detail
  • Strong organisation and time leadership skills
  • Problem solving using scientific principles
  • Strong verbal and written communication skills
  • Ability to author high quality user documentation
  • Ability to operate within multi-functional teams
  • Self-motivation & desire to learn
    • 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, gender, 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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.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 authorisation and employment eligibility verification requirements.

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