16693 – GLIMs Specialist – Cork Contractor

Purpose:

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. 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 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.

Responsibilities:

• 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), be the SME (downstream purification) 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 the 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.
• 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.
• 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.

Minimum Qualifications & Requirements:

• Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
• An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
• 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
• In-depth technical & operational knowledge of multiple unit operations in downstream purification including supporting areas such as buffer preparation.
• Strong understanding of technology transfer, scale up process, and cleaning verification/validation.
• 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 processes
• Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings
• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
• Can effectively partner with and influence stakeholders without direct solid line authority
• Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to the company
• Detail orientated, technical writing competency
• Excellent organizational skills with strategic thinking and vision for Technical Services
• Demonstrated ability to drive for results and lead innovation and change
• Self-driven, able to prioritize, and to orchestrate multiple activities at once
• Ability to deal with ambiguity and complexity and influence others across levels of the organization