Manufacturing Officer

2 weeks ago

London, United Kingdom BioTalent Full time

**GMP Manufacturing Officer, Scientist & Senior Scientist with CDMO - London**
***
**BioTalent are exclusively partnered with a well-funded start-up and innovation-driven CDMO that manufactures viral vectors and gene-modified cells to enable novel cell & gene therapies to enter clinical trials. Due to exceptional growth in the business, they are now looking to expand the existing team with the following positions**:

- Manufacturing Officers
- Manufacturing Scientists
- Manufacturing Senior Scientists

The positions will be based at their site in central London and require a full background check of all successful applicants. If you want to gain experience working with an organisation that are driven to accelerate the development of critical therapies then this is the perfect opportunity

Minimum experience needed for consideration:

- A relevant degree in Biological sciences, Biotechnology or Bioprocessing
- Experience within a GMP environment
- Practical experience in a manufacturing setting (this can be through a placement year)
- Theoretical knowledge or working experience in upstream (adherent or suspension) and downstream (filtration, chromatography, tangential flow filtration) operations
- Experience in aseptic processing and fill finish operations

Desired Experience:

- Experience with viral vectors would be advantageous
- Mentoring or leadership background
- Background in both upstream & downstream processing
- Experience in leading reporting, investigation and resolution of quality events
- Strong communication skills and capable of representing function at cross-disciplinary interactions
- Knowledge / awareness of regulatory guidelines
- Experience with equipment and process validation
- Experience with use of statistical tools

Key Responsibilities for Manufacturing Officers:

- Supporting manufacturing activities including transferring of material into cleanrooms, carrying out manufacturing operations, assisting with cleaning of cleanroom and assisting with sample shipment for testing.
- Supporting generation of GxP documents including MBRs, BOMs and SOPs
- Assist with the reporting, investigation and resolution of deviations encountered during GMP manufacturing activities.
- Support batch data collation, analysis and trending

Key Responsibilities for Manufacturing Scientists:

- Aseptically qualified operator for Grade A activities.
- Developing SME for process / equipment
- Responsible for generation of GxP documents including MBRs, BOMs and SOPs
- Reporting, investigation and resolution of quality events.
- Perform batch data collation, analysis and trending
- Participation in validation activities

Key Responsibilities for Manufacturing Senior Scientists:

- Leading manufacturing activities in GMP cleanrooms including staff supervision.
- Trained in both USP and DSP operations
- SME in at least one process / equipment
- Responsible for generation of GxP documents including MBRs, BOMs and SOPs
- Leading trouble shooting and process improvement activities
- Leading reporting, investigation and resolution of quality events.
- Leading validation activities
- Leading technology transfer or new product introduction to GMP
- Responsible for batch data collation, analysis and trending

***_BioTalent Ltd are acting as an employment agency in relation to this opportunity._**:

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