Scientist - Injectable Drug Product Development
JR United Kingdom
Slough, England, United Kingdom
Social network you want to login/join with: Scientist - Injectable Drug Product Development, Slough 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. Client: Planet Pharma Location: Slough, United Kingdom Job Category: Other EU work permit required: Yes Job Views: 5 Posted: 24.04.2025 Expiry Date: 08.06.2025 Job Description: Primary Responsibilities include: Leading the establishment of manufacturing processes for injectable drug products, guiding development from toxicology studies or first-in-human trials to BLA approval. Defining and optimizing manufacturing processes and parameters for clinical drug product production. Collaborating with internal teams and external stakeholders, including contract manufacturing organizations (CMOs), for project execution. Designing and conducting laboratory studies for drug product development, including data analysis and documentation. Analyzing manufacturing data to improve process understanding and characterization. Performing process risk assessments to ensure compliant operations. Designing sterile injectable drug product manufacturing processes for various forms. Defining preparation processes for clinical trial medicines. Supporting production of stability and clinical batches. Assisting with process qualification/validation, ensuring cGMP compliance. Contributing to regulatory submissions and addressing authority questions. Investigating and resolving quality deviations and complaints. Facilitating knowledge transfer from development to manufacturing. Improving departmental processes. Key Qualifications: 2 3 years of experience in liquid drug product development and/or manufacturing, with biopharmaceutical experience as a plus. Solid knowledge of liquid drug product development and cGMP manufacturing, especially under aseptic conditions. Technical expertise in sterile drug product development, including components, transfer, scale-up, and optimization. #J-18808-Ljbffr