Senior Specialist Technical Services Upstream

OverviewJob Title: Senior Specialist Technical ServicesIntroduction to role: Are you ready to make a difference in the world of biopharmaceutical manufacturing?As a Senior Specialist Technical Services, you'll play a pivotal role in supporting the cGMP manufacture of biological bulk drug substance at Alexion's facility in Blanchardstown, Dublin.Your expertise will be crucial in technology transfer, validation, and routine commercial manufacturing for both Upstream and Downstream processes.Collaborate with various departments to ensure successful facility startup and process qualification.Are you up for the challenge?AccountabilitiesProvide process expertise in Upstream (Cell culture focus) or Downstream manufacturing.Author and review process transfer documentation, gap assessments, technical protocols, and reports.Identify requirements for laboratory studies and oversee their design and execution.Support the introduction of new raw materials and consumables.Work closely with Quality, Supply Chain, and Manufacturing Operations to meet timelines.Identify and implement process improvements.Generate documentation protocols and lead plant supporting studies.Provide on-the-floor support for troubleshooting processing issues.Lead key process changes using change control systems.Ensure compliance with site EHS policy, cGMP, and other business regulations.Author and review common technical document sections for regulatory submissions.Serve as a subject-matter expert during regulatory agency inspections.Essential Skills/ExperienceMinimum of 5 years' experience in pharmaceutical manufacturing with expertise in Bulk Drug Substance manufacturing.Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing.Engage in continual improvement through new PAT technologies.Good interpersonal skills and ability to work effectively in a matrix organization.Ability to develop, present, and defend technical approaches.Can effectively partner with and influence stakeholders without direct authority.Ability to drive for results independently and adapt to changing priorities.Experience of Technology Transfer activities is advantageous.Knowledge or experience of start-up or systems would be ideal.Excellent communication skills and ability to influence across all levels.Technical writing competency.Excellent organizational skills with strategic thinking and vision.Demonstrated ability to drive for results and lead innovation and change.Self-driven, able to prioritize, and orchestrate multiple activities at once.Consistently demonstrate sound business judgment when making decisions.Ability to deal with ambiguity and complexity.Desirable Skills/ExperienceB.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.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.In-person working gives us the platform we need to connect, work at pace and challenge perceptions.That\'s why we work, on average, a minimum of three days per week from the office.But that doesn\'t mean we\'re not flexible.We balance the expectation of being in the office while respecting individual flexibility.Join us in our unique and ambitious world.At AstraZeneca, we are driven by our passion to innovate and create meaningful value in all we do.Our commitment to patients living with rare diseases inspires us to continuously push boundaries and make impactful changes.With a rapidly expanding portfolio, you\'ll have the opportunity to grow and thrive in an energizing culture that values diversity, inclusiveness, and connection.Join us on this journey where your career is not just a path but a chance to make a real difference.Ready to take the next step?Apply now and be part of something extraordinaryDate Posted18-Sep-****Closing Date15-Oct-****Our mission is to build an inclusive and equitable environment.We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.We welcome and consider applications from all qualified candidates, regardless of characteristics.We offer reasonable adjustments/accommodations to help all candidates to perform at their best.If you have a need for any adjustments/accommodations, please complete the section in the application form.#J-*****-Ljbffr