Analytical Sciences & Technology, Senior Scientist

Alexion; Blanchardstown; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

AstraZeneca’s Alexion division seeks a Senior Analytical Scientist to lead method development, validation, and technology transfers in on‑site Analytical Sciences & Technology laboratories in Ireland. The role drives data integrity, regulatory submissions, and manufacturing reliability through rigorous scientific leadership.

You will partner across Manufacturing, Development, Quality, Regulatory, and Supply to set analytical strategy, mentor staff, and deliver robust, defensible conclusions for

Qualifications

• Minimum Bachelor’s Degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
• Demonstrated (5+ years) experience in an analytical role in a bio‑pharmaceutical manufacturing or development area.
• Previous experience with analytical method development and optimisation
• Proven knowledge of cGMP/GLP requirements and implementation of standard methodologies to ensure technical excellence.

Responsabilités

• Design, refine, and stress‑test analytical methods to improve robustness, sensitivity, and throughput across product lifecycle stages.
• Author and execute protocols; lead method transfers to internal and external labs to ensure compliance with cGMP/GLP and regulatory expectations.
• Plan and run end‑to‑end studies from protocol creation to data analysis and reporting; deliver defensible conclusions for regulatory decisions.
• Perform method capability and trending to establish control strategies and drive continuous improvement.
• Lead or support analytical investigations to unblock manufacturing issues and reduce deviations.
• Prepare analytical content for technical reports and regulatory submissions; translate data into concise narratives.
• Provide hands‑on guidance to laboratory scientists; train new personnel in analytical methods.
• Maintain a safe, compliant lab environment; participate in risk assessments, audits, and incident investigations.
• Support critical lab studies outside standard hours to ensure continuity for time‑sensitive programs.

Connaissances

5+ years analytic experience

Analytical Method Development

cGMP/GLP knowledge

Lab leadership training

Cross-functional collaboration

Formation

Bachelor's Degree in Biochemistry/Chemistry/Microbiology

Master's degree preferred

Description du poste

Are you ready to lead analytical science that safeguards product quality and accelerates life‑changing medicines to patients? Step into a senior role at the heart of our Analytical Sciences & Technology laboratories, where your methods, decisions, and leadership directly influence product robustness, regulatory success, and manufacturing reliability.

You will partner closely with colleagues across Manufacturing, Development, Quality, Regulatory, Supply and Commercial to shape analytical strategy and deliver results that matter. This is an opportunity to set the standard for scientific rigor and data integrity while enabling technology transfers, de‑risking processes, and advancing a growing pipeline. How will you apply your analytical expertise to elevate method performance and solve complex, cross‑functional challenges?

Accountabilities

• Analytical Method Development and Optimization: Design, refine, and stress‑test methods to improve robustness, sensitivity, and throughput, ensuring fitness‑for‑purpose across product lifecycle stages.
• Qualification, Validation and Transfer: Author and execute protocols, analyze results, and lead method transfers to internal and external labs to ensure seamless adoption and compliance with cGMP/GLP and regulatory expectations.
• Study Design and Execution: Plan and run studies end‑to‑end, from protocol creation to data analysis and reporting, delivering clear, defensible conclusions that inform technical and regulatory decisions.
• Data Trending and Capability Analysis: Perform method capability and trending to establish control strategies, identify risks early, and drive continuous improvement.
• Investigations and Troubleshooting: Lead or support analytical investigations and problem‑solving to unblock manufacturing issues, reduce deviations, and improve right‑first‑time performance; discuss outputs with peers and stakeholders.
• Technical Documentation and Regulatory Support: Author analytical content for technical reports and regulatory submissions, translating complex data into concise, compliant narratives.
• Technical Leadership and Training: Provide hands‑on guidance to laboratory scientists, train new personnel in analytical methods, and role‑model scientific rigor, safety, and accountability.
• Compliance and Safety: Maintain a safe, compliant lab environment; uphold site EHS policy and cGMP; participate in risk assessments, audits, and incident investigations.
• Operational Flexibility: Support critical lab studies outside standard hours when needed, ensuring continuity for time‑sensitive programs.

Essential Skills/Experience

• Minimum Bachelor’s Degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
• Demonstrated (5+ years) experience in an analytical role in a bio‑pharmaceutical manufacturing or development area.
• Previous experience with analytical method development and optimisation
• Proven knowledge of cGMP/GLP requirements and implementation of standard methodologies to ensure technical excellence.
• This is an on‑site role, the duties of which are generally conducted in a lab environment. As is typical of a lab‑based role, employees must capable with or without an accommodation to: lift/carry items in accordance with manual handling principles; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non‑linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

Desirable Skills/Experience

• Masters / advanced analytical degree preferred
• Experience in authoring content for regulatory submissions.
• Digital and AI savvy

Why AstraZeneca

Join a company where scientific excellence meets real‑world impact for people living with rare and devastating diseases. You’ll experience the energy and autonomy of a fast‑moving biotech environment backed by the scale and investment of a global organization. Expect unexpected teams in the same room unleashing bold thinking, access to cutting‑edge technologies, and the chance to grow by stepping beyond your lane. We value kindness alongside ambition, and we connect your development to a larger purpose—advancing therapies where need is greatest and every decision can change a patient’s path.

EEO Statement

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.