Hobson Prior currently having an exciting opportunity for an Senior Engineer to join a leading pharmaceutical organisation who provide innovative medicines to patients globally. This role will be located in Cambridge on a permanent basis.
- Develop R&D laboratory process capabilities.
- You will be accountable to develop drug product manufacturing processes for vial, prefilled syringe, and cartridge product.
- To guide functions and teams on new manufacturing technology selection and development.
- To 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.
- You will complete process risk assessments such as FMEA, design characterisation and engineering studies, develop control strategies, author protocols, technical reports, and regulatory filing sections.
- Develop risk-based characterization and validation strategies for manufacturing processes.
- 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.
- Lead technology transfers to contract manufacturing organisations and internal manufacturing facilities for clinical and late-stage projects.
- Coordinate an internal sending unit team including development functions, supply chain, project management and QA.
- Any other assigned duties.
- Knowledge of formulation and fill-finish unit operations such as freeze-thaw, formulation, filtration, mixing, and aseptic filling.
- You will have a relevant technical degree in Biochemical, chemical, or pharmaceutical engineering, or a related engineering or pharmaceutical science field.
- Capable of developing and nurturing innovation opportunities and lead any changes.
- Previous experience in Biopharmaceutical drug product development for monoclonal antibodies and recombinant proteins.
- Previous experience of leading and delivering technology transfer of fill-finish processes.
- An understanding and experience applying Quality by Design (QbD), experimental design and statistical data analysis.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
$140000 - $150000 per annum
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