Celebrating 20 years of innovation - Discover how we've been a catalyst for regional growth and UK innovation for over two decades in CPI's Annual Review 2023-2024.
£32,500 - £40,500 per annum, dependent on experience.
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.
Why this role is important for CPI’s work
We are seeking a dedicated and detail-oriented GMP Production Scientist to join our Biologics team. The role holder will contribute to designing, transferring and executing GMP manufacturing processes. They will assist with maintaining our facilities to regulatory standards, ensuring cleaning, environmental monitoring, and maintenance schedules are up to date and compliant with GMP standards. They will generate relevant SOPs, write and review batch documentation for new and existing manufacturing processes.
Key tasks in the GMP Production Scientist role will include (but are not limited to) the below; please download the job description for full details:
1. To maintain consistent and document compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
2. To ensure Batch Records, logbook and GMP documentation are completed to a high compliant standard, in accordance with Good Documentation Practice.
3. To execute GMP manufacturing working the required shift pattern to ensure the process is completed start to finish, to a high compliant standard.
4. To work closely with GMP Operations, QA, and cross-functional teams to support the transfer of new processes into CPI's GMP manufacturing facilities.
5. To work with the Technical team to generate the New Product Introduction (NPI) transfer pack, including Safety Risk Assessments (SRA), Item/component, Technical Specifications, Training Matrix requirements, Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Bill of Materials (BOMs), and any other documentation required.
6. To contribute to facility fit and process design, including technical and equipment gap analyses.
The person we are seeking
1. Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industrial experience or educated to Degree level (or equivalent) in a Scientific/Engineering discipline plus significant industrial experience.
2. Experience running GMP manufacturing processes.
3. Knowledge of principles and practices of upstream and/or downstream science gained in academic or industrial environments.
4. Experience working with GMP documentation and Quality Management Systems.
5. Capable of generating, reviewing, and approving GMP documentation such as SOPs, Batch records, and technical input on QMS documents.
6. Evidence of building knowledge sharing and network building practices across teams and organizations.
7. Ability to take responsibility for diverse or complex technical activities, using initiative and judgment to implement innovative solutions in business-critical situations.
8. Ability to work between teams and convey technical details to audiences with varying degrees of technical knowledge.
It would be great if you also had:
1. Experience of biologics or pharmaceutical manufacturing/development, or GMP tech transfer background.
2. Experience working with mRNA.
3. Experience generating Safety Risk Assessments (SRAs).
4. Understanding of QbD and/or CMC principles.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
* Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme.
* Life assurance and accident insurance schemes.
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.
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