Job Description
Purpose The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS). The Technical Specialist will provide processing expertise to support routine commercial manufacturing, technology transfer, and process validation for Downstream manufacturing of new/existing drug substance (DS) manufacturing processes. The person will be required to work in close collaboration with Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to provide successful process support. The person should have experience in Downstream Purification unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability. Responsibilities Provide process expertise in Downstream unit operations to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill. Author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents. Data retrieval and review of batch data to support batch review and continued process verification Support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements. Work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines. Identify and implement process improvements, e.g. yield, cycle time reduction. Generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale. May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing. Provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution. Lead any key process changes using change control system. Adherence to 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. Requirements B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. Minimum 3+ years experience in Technical Services/ Process Development/ Manufacturing Support in a biological bulk drug substance manufacturing organization. Technical and operational knowledge of multiple unit operations in Downstream processing. 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. Technical writing competency. Requirements would be an advantage to have M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. Experience of authoring CMC sections of regulatory submissions. Experience of Continued Process Verification and Statistics would be ideal Skills: Bulk Drug Substance Downstream Process Development