Cell Culture Specialist
- NI & Ireland
- Contract
- Life Sciences
This vacancy has now expired
As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking Cell Culture Specialist to become part of a $500 million state of the art bio facility.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Provide process information and expertise to facilitate process/facility fit, and qualification of a large scale BDS 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).
- 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).
- 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.
- Collaborate to influence the design and implementation robust process control strategies, process risk assessments and associated documentation to support equipment qualification activities, PPQ studies, and key technical strategies supporting process improvements for yield increases and improvement of manufacturing robustness.
- 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.
- Author, review and approval of reports in support CMC sections of regulatory agency submissions and responses (as required).
- Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.
- 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
- Engage in continual improvement through assessment and use of new PAT technologies, by design of scientifically robust assessment protocols and study design
- Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings
If this sounds like something of interest to you, please apply today!
The candidate must have the rights to work in the location stated in the job advert.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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Megan
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