Introduction to role
The Senior Director, Analytical Science and Technology (AS&T) will establish and lead a new AS&T function within Technical Operations, focused on strengthening analytical robustness for commercial biologics. Co-located with the College Park QC laboratory, this role builds a proactive capability that monitors performance, responds rapidly to issues, and drives systematic remediation of method challenges to protect product release, business continuity, and compliance. The position owns analytical lifecycle management, method validation and improvement, and acts as a key technical bridge between QC, manufacturing, regulatory, and external testing organizations to modernize control strategies, enable efficient technology transfers, and improve right-first-time performance. Ready to shape how commercial biologics are controlled and released across a global network?

Accountabilities
Lead the creation and growth of the AS&T organization, setting a clear vision, priorities, and governance that distinguish AS&T from formal QC release testing while ensuring tight partnership with QC. Own the AS&T OpEx and CapEx budget, making investment decisions that build and sustain a high-performing technical team and fit-for-purpose analytical capabilities. Establish and maintain analytical lifecycle management across modalities, including bioassays/potency, residual impurity methods, and biophysical/biochemical methods, ensuring methods remain robust, optimized, and inspection-ready to support post-approval changes.

Design and operate phase-appropriate quality systems for AS&T with strong data integrity controls, documented training, and QA-linked change control. Implement a standardized support model for internal and external QC laboratories that delivers proactive monitoring, rapid response troubleshooting, investigational testing, and clear CAPA linkage to reduce deviations and rework. Reproduce atypical results, lead root cause analysis using orthogonal analytics, and apply design of experiments (DoE) for hypothesis testing and method improvement.

Ensure AS&T maintains instrumentation and capability at parity or advantage versus QC, with calibrated and qualified equipment suitable for support activities and orthogonal investigations, while retaining flexibility to prototype and validate method enhancements. Lead analytical technology transfer and validation for new and existing commercial laboratories, overseeing in-country testing readiness and structured knowledge transfer to in-country test labs. Direct product characterization studies and reporting to qualify and maintain reference standards, support comparability assessments, and ensure reference materials remain fit for use over time.

Serve as the single point of contact for method-related health authority questions by authoring and defending analytical sections of regulatory filings (e.g., IND/IMPD, BLA/MAA) and comparability justifications. Lead the specification committee and represent AS&T in technology and control strategy forums to advance decisions that modernize analytical control strategies and operating models. Act as the external technical interface with contract testing organizations to align on method intent, data expectations, investigation approaches, and harmonization of methods across sites. Maintain a single source of truth for method versions and validation status, managing global rollout and change control in partnership with QA and QC. How will you use this platform to elevate analytical science while safeguarding patients who rely on our medicines?

Essential Skills/Experience
• 15+ years in biologics analytical development and/or commercial analytical support, including method qualification/validation, characterization, and comparability for regulatory filings.
• Bachelor’s degree in Analytical Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or a related field.
• Proven leadership of analytical teams; effective partnership with QC and external testing organizations. Able to balance strategic oversight with hands on scientific problem solving.
• Direct authorship of analytical sections in regulatory submissions and responses; confident participation in inspections and health authority interactions.
• Strong collaboration and influence in matrixed, cross company environments; clear written and verbal communication.
• Sound scientific judgment and a pragmatic approach balancing rigor, speed, and resources.
• Ability to work in a hybrid office/lab environment. With or without reasonable accommodation: lift/carry per manual handling principles; work in controlled environments with biological/infectious/hazardous materials; gown/degown PPE; use a computer; communicate via phone/video/messaging; solve complex problems; collaborate effectively; and maintain availability during standard business hours.

Desirable Skills/Experience
• M.Sc. or Ph.D. in Analytical Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or a related field.
• Demonstrated application of Lean and Six Sigma at enterprise scale, with advanced statistical methods and design of experiments (DoE) used to improve method robustness, reduce deviations, and drive measurable performance gains.
• Track record of selecting, validating, and deploying digital and/or AI solutions in GMP laboratory environments (e.g., analytics platforms, automated data integrity controls, predictive monitoring), from business case through change management and sustained adoption.

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’s Rare Disease unit, work carries real meaning: closeness to patients shapes decisions every day, an entrepreneurial biotech spirit combines with the scale and investment of a global biopharma, and people are encouraged to stretch beyond their core remit to grow skills and impact! This is a place to define a unique career path while contributing to medicines for some of the most underserved patient communities; collaboration is grounded in integrity, inclusiveness, scientific rigor, and a shared commitment to changing lives now and in the future.

Date Posted

31-Mar-2026

Closing Date

29-Apr-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.

Senior Director, Analytical Science and Technology

Job Description