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 method lifecycle management, including authoring and executing protocols/reports for qualification, validation, co-validation, and transfer across internal and external sites. Familiarity with ICH guidelines and current expectations for method validation and analytical control strategies. Proficiency with statistical analysis and experimental design tools (e.g., JMP, Minitab) for capability assessment, trending, and robustness studies. Experience with LIMS/ELN systems and strong understanding of ALCOA+ data integrity principles. Proven contribution to inspections/audits and remediation activities, with a track record of sustaining inspection readiness. Experience supporting process characterization, comparability, and stability programs for biologics. Why AstraZeneca: Here, cutting-edge science meets real-world impact for people living with rare and devastating diseases. You will join a collaborative environment where diverse expertise comes together in the same room to spark bold ideas, backed by the scale and resources of a global company and the agility of a biotech mindset. We unite around patients, pairing scientific rigor with empathy, and we value kindness alongside ambition so you can push boundaries while being supported to grow. Your contribution will be visible and meaningful—shaping analytics that enable safe, effective therapies to reach those with the greatest unmet need. Call to Action: Step into this role to shape the analytical science that powers breakthrough medicines—bring your expertise and help create what patients need next. Date Posted 22-Oct-2026 Closing Date 04-Nov-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. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Analytical Sciences & Technology Scientist x 2.

more at Astrazeneca.

Analytical Sciences & Technology, Senior Scientist

QA Specialist, Drug Product

Associate Director, Market Access Contract Analytics

similar roles.

Physician - Non-Invasive Cardiologist (Concord Hospital - Laconia)

APRN - Pulmonary/Critical Care Inpatient (Per Diem - Weekends)

Operations Assistant

CDL Driver- Local and OTR