Biotechnology Manufacturing Specialist
2 weeks ago
Company Overview
">A global leader in contract manufacturing for medical devices, diagnostics, and drug delivery is seeking an experienced Biotechnology Manufacturing Specialist.
Salary
">The annual salary for this position is approximately £55,000.
Job Description
">This exciting opportunity involves the development and improvement of manufacturing processes, creating quotations for process development & manufacturing work, as well as supporting with technical troubleshooting of Fill Finish Processes.
You will collaborate across departments and support customers when necessary. Your responsibilities will include:
">- ">
- Drafting, writing, and reviewing process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records, and other documentation relevant to GMP manufacturing.">
- Drafting, writing, and reviewing Technology Transfer documentation for any processes being used for fill-finish.">
- Collaboratively improving and/or troubleshooting manufacturing processes and proposing needed protocols for data collections and/or experimentation.">
- Reviewing GMP material assessments and bill of materials for use in manufacturing.">
- Being the technical author of deviation impact assessments which feed into the Quality Management System.">
- Risk analysis of processes including prioritisation and implementation of mitigations.">
- IP generation and review.">
Required Skills and Qualifications
">To be considered for this role, you will have a keen eye for detail and strong communication skills. You will also have most of the following:
">- ">
- BSc/MSc in Biology, Pharmaceutical Science, Biotechnology, Biomanufacturing, or similar.">
- Previous relevant Process Development/MSAT function experience.">
- Experience working within cGMP manufacturing environments.">
- Knowledge of manufacturing process design, scaling, and characterisation.">
- Knowledge of QbD, DoE and statistical process control methodologies.">
- Managing CMOs and Suppliers in technical and project planning activities for process development, technology transfer and validation.">
- Validation activities including specification writing, qualification testing and reporting.">
- Leading elements of technology transfer into cGMP production.">
- Experience working under the ISO13485 and GMP quality systems.">
- Experience in risk assessment and risk management.">
Benefits
">This role offers a range of benefits, including Personal Days, Private Medical Cover, Enhanced MAT/PAT Leave, Bonus & more.
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