Cell Culture Specialist
Due to COVID-19, we are only accepting applications from those residing in Ireland at this time.
Responsibilities will include:
- Provide process information and expertise to facilitate process/facility fit, and qualification of a large scale Bulk Drug Substance facility through to NPI tech transfer startup, PPQ validation, launch and continual improvement of existing and future products in a multi-product BDS facility.
- Provide technical direction and provide SME oversight in an area of BDS manufacturing; (mammalian cell culture/downstream purification), be the SME (Cell Culture) to develop and defend technical rationale during regulatory audits and inspections
- Provide scientific and technical input to facilitate decision making
- Provide input and engage with Product Lifecycle Management (PLCM) of products
- Identify technical issues, improvement initiatives and guide resolution/completion of same
- Possess deep technical knowledge and understanding in BDS manufacturing processes; (mammalian cell culture/ downstream purification operations, cause and effect, scale up principles, QRM, process validation strategies) and apply and build on product portfolio.
- Shape and develop strategy approaches for Technical Services in areas such as Mammalian Cell Culture technologies, downstream purification technologies, Technology Transfer, PPQ, CPV approach and so forth, maintaining industry trends and advances.
- Provide Technical input, review/approval into documentation associated with materials, manufacturing control and enterprises systems (MCS/MES) including manufacturing and technical documentation.
- Ongoing Subject Matter Expert technical support to Technical Services and Manufacturing Operations by providing technical expertise for investigation and resolution for process deviations, CAPAs, change controls.
- May be required to work periodically out of normal business hours (temporary shift working or per out of hours policy) during periods of engineering and validation batch execution, as well as any other duties as required.
- Strong experience in a pharmaceutical manufacturing organization. Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer
- In-depth technical & operational knowledge of unit operations in cell culture processing, centrifugation, depth filtration. Understanding of cause and effect of cell culture metabolism
- Strong understanding of analytical methods and corresponding signals to enable control strategy development and improvement. Strong understanding of technology transfer, bioreactor scale-up process and scaling principles
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant
- Experience of Validation / Verification of GMP equipment or processes would be beneficial
- Experience of process/facility fit, design, commissioning and start-up of a bulk drug substance facility is beneficial
- Experience of Technology Transfer and post launch process improvements.
- Knowledge or experience of start-up or systems would be ideal
For more information on this position, please apply with a copy of your up to date CV today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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