19298923-Material Specialist-Dublin Contractor

This role is on a 12 month contract with a view to extension.

Purpose

The Technical Services Materials Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at our Client’s facility in Dublin. The Technical Services Materials Specialist will be responsible for providing support for new material introduced to the facility and will be required to work in close collaboration with Technical Services Technology Transfer Teams, Technical Services sustaining teams, Operations, Supply Chain, Quality, Quality Control, and other involved departments to ensure successful introduction and qualification of new materials.  The position is accountable for leading NMI workstreams to support projects and sustaining manufacturing and providing NMI expertise to support other functional groups.

Responsibilities

• Acting as technical SME to support the selection and introduction of critical raw materials and single-use components.
• Providing technical leadership for material component-related issues, complaints, and investigations.
• Liaising with Vendors to ensure they conduct adequate investigations and implement appropriate corrective actions when issues are identified.
• To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications, and outline testing requirements.
• To work closely with colleagues in Quality, Supply Chain, and Manufacturing Operations to ensure the availability and release of materials to meet technology transfer and routine manufacturing timelines.
• Lead any key process changes using the change control system.
• Adherence to the highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
• Adherence to the highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
• Ensure compliance with site EHS policy, cGMP, and other business regulations and participate in risk assessments, audits, and incident investigations.
• To serve as a subject-matter expert (SME) on NMI and process support during regulatory agency inspections.

Requirements

• B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
• B.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
• Experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization.
• Technical and operational knowledge of multiple unit operations in drug substance manufacturing.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
• Ability to present and defend technical and scientific approaches in both written and verbal form.
• Ability to drive for results independently and adapt to rapidly changing priorities.
• Experience in Technology Transfer activities is advantageous.
• Detail orientated.
• Technical writing competency.