Scientist - Injectable Drug Product Development
Planet Pharma
slough, england, United Kingdom
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.