Drug Product Process Design & Development Scientist
Hobson Prior
Belgium, Belgium
9 dagen geleden

Contractor - Scientist, Drug Product Process Design and Development

Scope :

Technical support of biologics in the management / coordination of biological drug product development, especially for all related activities to Drug Product Process Design and Development and in the transfer to GMP manufacturing sites (internal or external).

To support activities for defining and selecting drug product manufacturing processes and components for support to clinical manufacture (from early to late stage projects, e.

g. support activities for pre-clinical, stability, Phase 1 / 2 / 3 and commercialisation).

Responsibilities :

  • Support the definition of DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or others
  • Provide all appropriate support to drug product process development activities (eg extractable volume assessment, target fill volume assessment, compatibility assessments, clinical blinding)
  • Support any technical transfer activities up to Phase 3 inclusive
  • Provide support to ensure timely delivery of Clinical trial material to CTSO
  • Ensure products are manufactured in accordance with UCB quality system, cGMP and latest regulatory requirements
  • Provide support to 1st line troubleshooting & process improvement for project up to completion of validation exercise
  • Ensure Technical Satellite Team member role representing BPhS department
  • Preparation of protocols and reports in relation to drug product development activities
  • Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes
  • Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities
  • Experience :

    Minimum 2-3 years experience in drug product development and steriles manufacturing within the biopharmaceutical industry is required.

    An understanding of the issues and challenges of taking products coming from Research to development process and into clinical manufacture is required.

    Good knowledge and technical experience in parenteral liquid and lyophilized product development and cGMP manufacturing under aspetic conditions would be required.

    Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization.

    Good knowledge of cGMP and regulatory requirements.

    Knowledge of analytical, preformulation and formulation development.

    Understanding of antibody drug product manufacturing process and scale-up.

    KPIs :

    Expertise in supporting the required drug product activities for the manufacture of cGMP material and timely delivery of activities to internal and external partners.

    Authorship in DPPDD protocols and reports as well as related documentation.

    Development of procedures describing the activities of DPPDD and interactions with the different CMO's, etc.

    Supporting role for generation of quality documentation to ensure inspection readiness for audit / inspection by regulatory agencies

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