QC Senior Analyst, Analytical NPI (12 MONTH FIXED TERM CONTRACT)

Alexion Pharmaceuticals; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

AstraZeneca is seeking a QC Senior Analyst focused on Analytical NPI to ensure method transfer, validation, and troubleshooting deliver reliable, inspection-ready outcomes for clinical and commercial supply. You will strengthen cGMP practices, safeguard data integrity, and support readiness in a fast-paced environment.

You will lead investigations, coach analysts, and drive continuous improvement while adopting new analytical technologies.

Qualifications

• In depth knowledge of regulatory requirements for Chemistry or Biochemistry methods in cGMP operations.
• Biochemistry or Chemistry knowledge with lab experience.
• Experience with investigation methodology and method troubleshooting.
• Attention to detail when following procedures and documentation.
• Strong technical writing and reporting skills.
• Experience using AI tools to aid risk assessments, deviations, and change controls while maintaining compliance.
• Ability to work with minimal supervision on routine duties.

Responsibilities

• Perform cGMP compliant lab activities and ensure data integrity.
• Lead method transfer and validation studies with regulatory alignment.
• Provide SME support and troubleshooting for NPI activities.
• Lead investigations and CAPAs with clear root cause analysis.
• Oversee training for new assays and staff performance.
• Drive continuous improvement to method robustness and workflows.
• Evaluate new analytical technologies to improve lab efficiency.
• Maintain training and documentation accuracy across method lifecycles.

Skills

Regulatory knowledge

Biochemistry/Chemistry knowledge

Investigation methodology

Attention to detail

Technical writing

AI writing tools

Independent work

Education

BSc in Chemistry or biological science

Tools

LIMS

Empower/Chromeleon

Electronic quality systems

Job description

Are you ready to bring new analytical methods online faster so life-changing medicines reach patients sooner? As a QC Senior Analyst focused on Analytical NPI at AstraZeneca, you will be the technical anchor who turns method transfer, validation, and troubleshooting into reliable, inspection-ready outcomes that enable clinical and commercial supply.

You will join a team that thrives on urgency and precision, supporting new therapies for people with rare and devastating conditions. From hands-on execution in a cGMP lab to shaping how we adopt new technologies, your work will directly influence speed-to-patient and product robustness. Do you thrive on turning investigations into lasting improvements?

Accountabilities:

• cGMP Laboratory Excellence: Perform all lab functions in compliance with cGMP, safeguarding data integrity and audit readiness.
• Method Transfer and Validation: Follow written protocols for transfer and validation activities, planning and executing studies that meet regulatory expectations and manufacturing timelines.
• Technical Troubleshooting and SME Support: Troubleshoot new methods and instrumentation; provide subject matter expertise and day-to-day technical guidance for NPI activities.
• Investigation Leadership: Lead and complete execution of investigations/CAPAs in a timely manner, driving clear root cause and effective preventive actions.
• Training Leadership: Serve as training lead in specific assays, overseeing all training activities for new personnel to achieve consistent, qualified performance.
• Continuous Improvement: Drive continuous improvement initiatives within the NPI team to increase method robustness, reduce cycle time, and simplify workflows.
• Technology Enablement: Evaluate and exploit new analytical technologies to enhance method performance, data quality, and lab efficiency.
• Compliance and Readiness: Ensure training is current for all job functions performed; support the management team as required; maintain accurate documentation throughout the method lifecycle.

Essential Skills/Experience :

• In depth knowledge of current regulatory requirements for Chemistry or Biochemistry methods in support of cGMP operations supporting clinical and commercial manufacturing
• Good technical knowledge in the area of Biochemistry or Chemistry.
• Good experience in investigation methodology and method troubleshooting
• Ability to follow written procedures with close attention to detail
• Good report writing and technical writing skills
• Ability to use AI tools to support technical writing (risk assessments, change controls, deviations) while understanding compliance boundaries
• Ability to function with minimal supervision for routine job duties
• Education: BSc in Chemistry or a biological science, 4-7 years' experience, or equivalent combination of education and experience.

Desirable Skills/Experience :

• Experience transferring and validating analytical methods for biologics or complex modalities (e.g., HPLC/UPLC, LC-MS, CE, ELISA, PCR).
• Proficiency with LIMS, Empower/Chromeleon, and electronic quality systems for deviations, CAPA, and change control.
• Familiarity with ICH Q2(R2), method lifecycle principles, and data integrity guidance.
• Demonstrated success leading cross-functional lab investigations and presenting findings to quality and regulatory stakeholders.
• Background in Lean, Six Sigma, or other CI methodologies applied in QC environments.
• Hands-on experience qualifying new instruments and implementing new analytical technologies.
• Prior responsibility for training programs, assay onboarding, and qualification of analysts.

Why AstraZeneca:

Join a team where scientific rigor meets real-world urgency and where your expertise in QC directly accelerates access to medicines for underserved patients. You will feel the energy of a biotech mindset supported by the scale and stability of a global biopharma-unexpected teams in the same room, from QC to Manufacturing to Regulatory, unleashing bold thinking to solve hard problems. We invest in your growth with practical development and mentoring, and we value kindness alongside ambition, so you can push boundaries while being supported to do your best, most meaningful work.

Date Posted
02-Oct-2026

Closing Date
20-Oct-2026

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.