Associate Scientist II, Clinical QC - GMP… at Alexion… · New Haven

Are you ready to turn rigorous GMP sample management and clinical QC testing into faster, confident decisions for people living with rare diseases? In this role you will sit at the heart of our biologics development engine, ensuring every sample is accounted for, every test is executed to standard, and every data point moves our pipeline from early stage through Phase III with speed and integrity.

You will lead the flow of clinical stability and release samples from shipment to result, bringing discipline to gLIMS/sample management and precision to compendial testing. By collaborating across development, clinical supply, manufacturing, quality and external partners, you will translate laboratory excellence into reliable batch release and stability insights that optimize processes and protect patients. Can you spot a trend in stability data and act before it becomes a deviation?

Accountabilities

GMP Sample Management and Logistics:

• Own receipt, inventory, chain-of-custody and gLIMS data entry for GMP samples; manage compliant shipping/receiving, including temperature-controlled logistics; keep audit-ready records that withstand internal and external scrutiny.

Clinical Stability Operations:

• Plan and execute laydowns; aliquot drug substance and drug product across multiple presentations (bulk bag, vial, pre-filled syringe, auto-injector) to generate on-time, right-first-time testing.

Compendial Testing Excellence:

• Perform assigned compendial methods for in-process, drug substance and drug product release and stability, including protein concentration, appearance, pH, osmolality, sub-visible particulates (light obscuration), and device functionality; deliver high-quality data that informs batch disposition and process optimization.

Quality Systems and Compliance:

• Operate to cGxP standards; maintain legible, contemporaneous laboratory records; contribute to laboratory investigations, deviations, CAPAs and change controls; support issuance and review of CoAs/CoTs.

Methods, Validation and Documentation:

• Write and review methods, SOPs, qualification/validation protocols and technical reports; compile and trend assay and instrument performance to drive robustness and reproducibility.

Laboratory Operations and Readiness:

• Order, receive, label and inventory supplies; clean and maintain equipment; prepare reagents and solutions; recognize and escalate aberrant results or sample conditions; maintain current training and support peer training in areas of competence.

Cross-Functional Collaboration:

• Represent Clinical QC on project teams, providing technical input that accelerates timelines and de-risks development; present findings to colleagues and stakeholders; provide clear task tracking and status updates with minimal supervision.

Continuous Improvement and Reach:

• Identify opportunities to streamline workflows and strengthen data integrity; contribute to inspection readiness; support a global remit with limited domestic/international travel (~5%) to align external and internal partners.

Essential Skills/Experience

• A Bachelor of Science (BS) degree in Immunology, Biochemistry, Chemistry, Chemical Engineering, or related discipline from an accredited university with 2-5 years of relevant experience or equivalent combination of education and experience.
• In depth knowledge of GMPs and their application in the environment is needed.
• The individual in this position is expected to have a strong understanding of the Biological Chemistry laboratory environment and be familiar with all laboratory equipment / instrumentation, procedures, and responsibilities.
• Understand and follow written procedures when conducting experiments and applying methods.
• Ability to document procedures and data in peer-reviewed laboratory notebooks and/or LIMS.
• Able to organize scheduled work on a routine basis and requires minimal supervision. When asked, the individual can provide updates and tracking on tasks.
• The ability to communicate verbally and in a written format is required.
• The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected.
• Communicate findings to colleagues within the group through presentations.

The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without accommodation, to: 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 Veeva Vault ECMS, ELN, gLIMS, Lean 6 Sigma
• Experience with domestic and international shipping requirements with knowledge and experience in cold chain management, cryogenic sample handling, or temperature-controlled shipping.
• Involvement with health authority inspections (FDA, EMA, MHRA, etc.) and experience preparing responses and/or remediation activities.

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 four 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.

Why AstraZeneca

Here you will help advance biologics that address profound unmet needs, working in a rare disease organization that combines the energy of a nimble biotech with the reach of a global science leader. We bring diverse experts together at the bench and in the plant to move data from stability chambers to decision-makers quickly, always guided by the lived experiences of patients and caregivers. You will grow alongside supportive leaders and peers who value kindness as much as ambition, with access to modern platforms and tools that let your best science show up every day. Your contribution will be visible, consequential and connected to a purpose that matters.

If you are ready to transform meticulous GMP sample management and clinical QC into measurable impact for patients, step into this role and help us raise the standard on every batch we release.

Date Posted

12-May-2026

Closing Date

05-Jul-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.