Technical Service Specialist Downstream

Technicial Services Specialist Downstream – Team Horizon

We are seeking applications for an experienced Technical Services Specialist to join our clients Bulk Drug Manufacturing facility in Dublin.

As the Downstream Specialist Technical Services, you have primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at the site.

You will be responsible for providing scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing, and process/continual improvement programs.

The position requires effective cross-functional collaboration with external contractors and internal partners including Manufacturing, Process Development, Engineering, Regulatory, QC and Quality to provide support of manufacturing of BDS.

 

Why you should apply:

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  This is an excellent opportunity to join a world class manufacturing operation, with an outstanding focus on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.


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  There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

 

What you will be doing:

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  You will provide scientific and technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation, routine manufacturing,


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  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.


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  Provide technical direction and provide SME oversight in an area of BDS manufacturing; (mammalian cell culture/downstream purification), be the SME (downstream purification) to develop and defend technical rationale during regulatory audits and inspections.


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  Provide input and engage with Product Lifecycle Management (PLCM) of products.


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  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 our client’s product portfolio.


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  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.


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  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.


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  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.


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  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.


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  Author, review and approval of reports in support CMC sections of regulatory agency submissions and responses (as required).


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  Contribute to successful regulatory agency inspections by providing subject-matter expertise on mammalian cell culture/downstream purification, technology transfer and manufacturing processes.

 

What you need to apply:

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  Minimum undergraduate degree in chemistry, biology, engineering or related discipline.


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  An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.


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  Min. 5 years+ experience in a pharmaceutical manufacturing organization. Bulk Drug Substance manufacturing, with previous experience in downstream unit operations, process/facility fit, New Product Introduction Technology Transfer


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  In-depth technical & operational knowledge of multiple unit operations in downstream purification including supporting areas such as buffer preparation.


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  Strong understanding of technology transfer, scale up process, and cleaning verification/validation.