Drug Product Process Development Scientist

Job Title – Drug Product Process Development ScientistLocation – SloughContract Length / Perm – 12 monthsPay Rate – £24 p/h PAYEWe are seeking a skilled Drug Product Development Specialist to support the development of injectable drug products from early clinical phases through to regulatory approval. This is a 12-month contract role within the Pharmaceutical Development Sciences (PDS) team, focused on ensuring robust, compliant, and scalable manufacturing processes for sterile injectable medicines.Key ResponsibilitiesLead the design and optimization of injectable drug product manufacturing processes (liquid and lyophilized forms).Define process parameters for clinical manufacturing and support preparation for regulatory submissions.Collaborate with internal teams and external partners, including contract manufacturing organizations.Conduct lab-based studies to support drug product development (e.g., filter sizing, compatibility assessments, fill volume testing).Analyze critical process data to improve understanding and ensure process robustness.Perform risk assessments and support process validation activities.Ensure compliance with cGMP, quality standards, and regulatory requirements.Contribute to clinical trial preparation and support the manufacture of stability and clinical batches.Assist in responding to regulatory queries and resolving quality-related issues.Support knowledge transfer from development to commercial manufacturing.Requirements2–3 years of experience in drug product development or manufacturing within the pharmaceutical industry.Experience in biopharmaceuticals and aseptic manufacturing (e.g., vial, syringe, cartridge filling) is a plus.Strong understanding of sterile drug product components, process scale-up, and optimization.Familiarity with regulatory standards and cGMP practices.

Created: 2025-09-10