Job Description
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.