Senior Technical Specialist, Upstream Technical Services

Position Summary

The Senior Specialist Technical Services has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The Senior Technical Specialist will provide processing expertise to support the technology transfer, validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The Senior Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer and vaklidation related milestones, with particular emphasis on new product introduction, Process Validation (PPQ), Cleaning Validation, Process Monitoring, Risk Assessment (using QRM tools), and building

strategies / SME capability.

Principal Responsibilities

• To provide process expertise in one, or both of the following disciplines:
  • Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
  • Downstream 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.
• To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
• To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies
• 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 availability and release of materials to meet technology transfer and routine manufacturing timelines
• To identify and implement process improvements, e.g. yield, cycle time reduction
• To 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.
• To 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
• To author and review common technical document (CTD) sections and reports for regulatory agency submissions
• To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.

Qualifications

• Minimum of 5 years’ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in cell culture unit operations, process/facility fit, New Product Introduction Technology Transfer.
• Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
• Engage in continual improvement through assessment and use of new PAT technologies.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a 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. Drives technical decisions balancing product quality and operational requirements.
• Ability to commit to results independently and adapt to rapidly changing priorities.
• Experience of Technology Transfer activities is advantageous.
• Knowledge or experience of start-up or systems would be ideal.
• Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external to Alexion.
• Technical writing competency.
• Excellent organizational skills with strategic thinking and vision for the group.
• Demonstrated ability to commit to results and lead innovation and change.
• Self-driven, able to prioritize, and to orchestrate multiple activities at once.
• Consistently demonstrate sound business judgment when making
• decisions.
• Ability to deal with ambiguity and complexity and influence others across levels of the organization

Education

• B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
• 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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.