Drug Product Process Development Scientist

Job Description

Job Title – Drug Product Process Development Scientist

Location – Slough

Contract Length / Perm – 12 months

Pay Rate – £24 p/h PAYE

We 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 Responsibilities

• Lead 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.

Requirements

• 2–3 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.