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.

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.

Provide Technical input, review/approval into documentation associated with materials, manufacturing control and enterprises systems (MCS/MES) including manufacturing and technical documentation.

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.Ensure current with Regulatory frameworks/changes, and industry trends, ensuring robust and scientifically sound rationale and justifications are embedded into the Companies Technical and Manufacturing 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.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 the product portfolio.Identify technical issues, improvement initiatives and guide resolution/completion of same.Provide input and engage with Product Lifecycle Management (PLCM) of products.

Provide scientific and technical input to facilitate decision making.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.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.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. The successful candidate 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 Downstream Specialist Technical Services has primary responsibility for providing scientific & technical support of (cell culture derived) drug substance manufacturing processes performed at the company.

Glims in validation