Introduction to role
Are you ready to turn cutting‑edge analytics into faster, more reliable manufacturing for therapies that change lives? In this role, you will shape how we understand and control complex biologics by developing, transferring, and optimizing methods that enable confident scale‑up and robust commercial performance.
Based in our MSAT Labs at College Park, you will partner with process engineers, manufacturing, and quality to unlock deeper insights into protein behavior and process capability. Your work will reduce technical risk in engineering and technical batches, speed decision‑making, and strengthen lifecycle knowledge from development through commercial supply. How will you use your bioanalytical expertise to de‑risk manufacturing and move life‑changing medicines to patients sooner?
Accountabilities
Analytical Method Transfer and Qualification: Transfer, qualify, verify, and validate analytical methods; execute testing for engineering and technical batches; generate protocols and reports; enhance technical success while reducing risk.
Method Development and Optimization: Design, develop, and optimize analytical methods supporting MSAT studies; improve sensitivity, specificity, and robustness to meet program needs.
Technology Assessment and Feasibility: Run “sandbox” feasibility assessments for new technologies such as PAT and inline monitoring as well as rapid techniques; extract actionable insights into protein chemistry and quantification to inform future adoption.
Timely Testing and Reporting: Deliver high‑quality data on agreed timelines; implement and refine high‑efficiency systems for scheduling, analysis, and documentation to accelerate study readouts.
Manufacturing Support and Troubleshooting: Apply analytical testing to resolve manufacturing issues, recommend improvements, and align solutions with regulatory and commercial manufacturing requirements.
Lifecycle Knowledge Management: Maintain product and process analytics history across the commercial lifecycle, preserving development context to inform control strategies and continuous improvement.
Compliance and Safety: Uphold site EHS policy, cGMP/GLP, and business regulations; contribute to risk assessments, audits, and incident investigations.
Flexibility for Lab Studies: Support periodic work outside normal business hours or weekend rota to keep critical lab studies moving.
Broader Impact: Translate lab insights into process understanding and control strategies that scale, reduce deviations, strengthen release readiness, and enable reliable supply.
Essential Skills/Experience
Degree in Life sciences, chemistry, analytical, or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering/method development/testing.
Previous experience and technical knowledge of analytical methodologies on biologicals in either research or biopharmaceutical manufacturing roles in Technical, R&D, or Process Development/Optimisation.
Previous hands‑on experience of Bio‑analytical techniques and methodologies for biologicals.
Previous experience with analytical method development and optimisation.
Proven knowledge of cGMP/GLP requirements and implementation of standard methodologies to ensure technical excellence.
Ability to travel up to 10%.
Lab environment ability: lift/carry items in accordance with manual handling principles; work comfortably in a controlled environment with 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
Experience with PAT, inline/online monitoring, spectroscopy, or rapid analytical approaches.
Proficiency in chromatographic and bioanalytical platforms for biologics (e.g., HPLC/UPLC, LC‑MS, CE‑SDS, icIEF, ELISA, qPCR).
Demonstrated use of design of experiments, data visualization, and multivariate analysis to improve method robustness and process understanding.
Familiarity with LIMS, ELN, data integrity principles, and automated data processing.
Background in tech transfer, comparability, and validation documentation supporting regulatory interactions.
Strong understanding of protein chemistry, stability, and degradation pathways relevant to biologics.
Experience collaborating with manufacturing, quality, and development in a regulated environment.
Continuous improvement mindset, with exposure to Lean or Six Sigma methodologies.
Why AstraZeneca
Join a science‑led community that stays close to the people we serve, using real experiences to guide smarter decisions and bolder analytics. You will feel the energy of a nimble biotech coupled with the reach of a global leader, where method scientists, process engineers, data specialists, and manufacturing partners come together to unlock faster, safer production. We invest in modern platforms that stretch what analytics can reveal, and we value kindness alongside ambition so you can take brave ideas from sandbox experiments to shop‑floor impact. Here, your contribution shortens the path from complex data to a therapy reaching someone who has been waiting.
Call to Action
Bring your analytical expertise where it will matter most—apply today to turn rigorous science into reliable supply and faster impact for patients!
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 any need for adjustments/accommodations, please complete the section in the application form.
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