Scientist - Injectable Drug Product Development

Planet Pharma
Slough
3 weeks ago
Applications closed

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Planet Pharma is pleased to be recruiting for a Scientist - to work within Injectable Drug Product Development for a leading clinical trials company in the UK.


Primary Responsibilities:

  • Serve as the technical lead in establishing robust manufacturing processes for injectable drug products, guiding development from toxicology studies or first-in-human trials to BLA approval.
  • Define and optimize manufacturing processes and parameters for clinical drug product (DP) production.
  • Collaborate with cross-functional internal teams and external stakeholders, including contract manufacturing organizations (CMOs), to ensure seamless project execution.
  • Design and conduct laboratory studies for drug product development activities, including data capture, analysis, and documentation preparation (e.g., protocols, reports, filter sizing, compatibility assessments, clinical blinding, etc.).
  • Analyze critical manufacturing data to enhance process understanding and characterization.
  • Perform process risk assessments to ensure robust and compliant operations.
  • Design sterile injectable DP manufacturing processes for liquid or lyophilized forms in vials, pre-filled syringes, or combination products.
  • Define investigational medicine product preparation processes for clinical trials.
  • Support the timely production of stability and clinical DP batches.
  • Provide assistance for process performance qualification/validation, ensuring adherence to cGMP, quality systems, and regulatory requirements.
  • Contribute to CMC regulatory submissions, regulatory briefings, and address authority questions.
  • Investigate and resolve DP quality-related deviations and complaints.
  • Facilitate knowledge transfer from late-phase development to commercial manufacturing of validated DP processes.
  • Help enhance departmental processes and ways of working.

Key Qualifications:

  • 2–3 years of experience in liquid drug product development and/or manufacturing within the pharmaceutical industry (biopharmaceutical experience is a plus).
  • Solid knowledge of liquid drug product development and cGMP manufacturing, especially under aseptic conditions (e.g., vial, cartridge, and pre-filled syringe filling processes).
  • Technical expertise in sterile DP development, including DP components, process transfer, scale-up, and optimization.

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