Associate Scientist II, Clinical QC - GMP Sample Management and Testing ADQC

Alexion • New Haven, CT

5d • Hybrid

About The Position

This role is 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. The Associate Scientist II 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, this role will translate laboratory excellence into reliable batch release and stability insights that optimize processes and protect patients.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

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

Benefits

• We balance the expectation of being in the office while respecting individual flexibility.
• Access to modern platforms and tools that let your best science show up every day.
• Supportive leaders and peers who value kindness as much as ambition.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level