Scientist - Injectable Drug Product Development

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.