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6 Apr 2017

Full-Time Development Scientist

Sanofi Genzyme – Posted by admin Waterford, County Waterford, Ireland

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Job Description

Development Scientist

Requisition ID: 41898

Role overview:

  • Competent in liquid and solid state characterisation of drug product, provide technical support and development to team in these key areas;
  • Competent in protein science – protein structure, function, aggregation, degradation – Perform characterisation analysis of proteins;
  • Manufacturing Support – product impact to support batch release;
  • Experience one or more of the following – Lyophilisation, Formulation, Filtration, Sterile Filling, Technology Transfer, Scale Up, QbD, PAT;
  • Support the day to day running of the small scale development laboratory;
  • Write and maintain work instructions associated with the laboratory;
  • Lead and Support the execution of laboratory studies;
  • Maintain Vendor Management Inventory (VMI);
  • Strong team player, communicator, excellent presentation and technical writing skills.

Desired Skills/Knowledge

  • Strong understanding of biopharmaceuticals, protein science (structure, function, degradation), stability;
  • Has experience with protein characterisation techniques such as CD, FTIR, DSC, Fluorescence Spectroscopy;
  • Liquid and solid state characterisation of drug product, provide technical support and development to team in some of the following these key techniques – Rheometry, XRD, mDSC, TGA, BET, DVS, Karl Fisher;
  • Has direct observational experience of full-scale manufacturing processes and associated key analytical techniques;
  • Direct experience in day to day laboratory management including Safety, VMI, Equipment management etc.;
  • Project Management experience; Product/Scientific Risk Assessments;
  • Technology Transfer & Scale up experience;
  • Knowledgeable on the fill finish manufacturing processes for the product and the interactions between product and process that impact CQAs and long term stability;
  • Has demonstrated understanding and application of relevant Compendial and Pharmacopeial standards to their specification of interest;
  • Can review on-going product data (e.g. stability trends, Development studies);
  • Understanding of ICH Guidelines Q5, 8, 9, 10; Quality by Design (QbD); Pharmaceutical Development, Product Comparability;
  • Can interpret results, trends, investigations, can troubleshoot method and equipment issues, working logically and systematically to resolve problem;
  • Excellent Communication and Presentation skills;
  • Stakeholder management, networking (internal and external);
  • Strong demonstrated leadership skills, a self-manager.

Qualification

MSc or equivalent.

Experience:

At least 1-3 years’ experience in a relevant pharmaceutical or biopharmaceutical role.

How to Apply

https://www.sanofigenzyme.com/en/Careers/Job-Search/Full-and-Part-Time-Opportunities.aspx

Job Categories: Medicine. Job Types: Full-Time.

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