Alexion Pharmaceuticals Tech Spec, BDS Manufacturing, Tech Svcs in Ireland
The Technical Specialist will support the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The position will provide cell culture and / or downstream processing expertise to support the facility design, start-up and routine commercial manufacturing. The Technical Specialist will be responsible for technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Process Sending unit, 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 related milestones, with particular emphasis on new product introduction, Technology Transfer, Process Owner, Process Validation, Process Monitoring, Risk Assessment, and SME build.
To provide process expertise in the area of buffer/media preparation, bulk drug substance manufacturing (cell culture, protein purification) to support the successful startup of Alexion’s BDS facility in Dublin.
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.
Temporary shift working support may be required during periods of engineering and validation batch execution.
To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations. Lead any key process changes using change control management system.
To author and review IND, BLA and other technical documents for regulatory agency submissions.
To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.
Minimum 2-5 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 cell culture and/or downstream processing.
Experience of Technology Transfer.
Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization.
Ability to present and defend technical and scientific approaches in both written and verbal form. Experience of authoring CMC sections of regulatory submissions would be advantageous.
Ability to drive for results independently and adapt to rapidly changing priorities.
Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.