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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.
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