Introduction to roleAre 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?AccountabilitiesAnalytical 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, reducing deviations, strengthening release readiness, and enabling reliable supply.Essential Skills / ExperienceDegree in Life sciences, chemistry, analytical, or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering/method development/testingPrevious experience and technical knowledge of analytical methodologies on biologicals in either research or biopharmaceutical manufacturing roles in Technical, R&D, or Process Development/OptimisationPrevious hands‑on experience of Bio‑analytical techniques and methodologies for biologicalsPrevious experience with analytical method development and optimisationProven knowledge of cGMP/GLP requirements and implementation of standard methodologies to ensure technical excellenceAbility to travel up to 10%The duties of this role are generally conducted in a lab environment. As is typical of a lab‑based role, employees must be 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 hoursDesirable Skills / ExperienceExperience with PAT, inline/online monitoring, spectroscopy, or rapid analytical approachesProficiency 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 understandingFamiliarity with LIMS, ELN, data integrity principles, and automated data processingBackground in tech transfer, comparability, and validation documentation supporting regulatory interactionsStrong understanding of protein chemistry, stability, and degradation pathways relevant to biologicsExperience collaborating with manufacturing, quality, and development in a regulated environmentContinuous improvement mindset, with exposure to Lean or Six Sigma methodologiesEEO StatementOur 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.
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