Are you ready to turn complex biology into reliable, regulatory-grade analytics that keep life-changing medicines moving to patients who need them most? Join a rare disease-focused team within AstraZeneca where your analytical expertise directly safeguards product quality, accelerates batch release, and strengthens our pipeline.
Based in our College Park labs, you will collaborate across manufacturing, development, quality, and regulatory functions to design, validate, and transfer robust analytical methods. From day one, your work will underpin decisive investigations, confident decision-making, and a culture of scientific rigor and data integrity. How will you leverage your bio-analytical experience to elevate method performance and deliver results that matter?
Accountabilities:
Analytical Method Development and Optimization: Develop and refine analytical methods for biologics to improve specificity, sensitivity, and throughput, enabling reliable product characterization and release.
Method Qualification, Validation, and Transfer: Lead and support method qualification, validation/co-validation, and transfer between laboratories and sites, aligning with cGMP/GLP and regulatory expectations.
Method Capability and Data Trending: Perform capability analyses and trend data to establish control strategies, detect drift, and drive continuous improvement in method performance.
Study Design and Execution: Create protocols, execute studies in the laboratory, analyze data, and produce clear, defensible reports and technical assessments that inform program decisions.
Analytical Investigations and Troubleshooting: Provide hands-on testing and root-cause analysis to resolve manufacturing and method issues, supporting deviations, CAPAs, and change controls.
Manufacturing Support: Deliver targeted analytical testing to de-risk processes, remove bottlenecks, and support robust process control across the manufacturing network.
Laboratory Operations and Readiness: Manage consumables and reagents, maintain equipment, and perform daily operational activities to keep the lab inspection-ready and safe.
Compliance and EHS: Uphold site EHS policy, cGMP/GLP, and business processes; champion data integrity and scientific rigor to ensure compliant, audit-ready outcomes.
Flexibility and Responsiveness: Support ongoing lab studies that may require periodic out-of-hours work or weekend rota participation to maintain program momentum and timelines.
Essential Skills/Experience :
Minimum Bachelor’s Degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
Demonstrated experience in (bio)pharmaceutical manufacturing or development.
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.
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, with or without an accommodation, be capable 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 :
Advanced degree (Master’s or PhD) in a relevant scientific discipline.
Hands-on experience with biologics analytical techniques such as HPLC/UPLC, CE-SDS, icIEF/cIEF, ELISA, qPCR, LC-MS, peptide mapping, and potency assays.
Demonstrated expertise in…