Associate Specialist, Cell Therapy

AstraZeneca•Los Angeles, CA

14h

About The Position

The Associate Specialist, Cell Therapy supports routine manufacturing execution, cleanroom readiness, material preparation, equipment setup, documentation accuracy, and real-time issue escalation under the guidance of Specialists, Leads, or Manufacturing management. The role requires recognizing when an activity, condition, or observation may differ from accepted practice and escalating it appropriately. The position supports safe and compliant execution of assigned manufacturing tasks, adherence to approved procedures and batch records, accurate and timely documentation, cleanroom discipline, contamination control, and timely escalation of issues that could affect product quality, schedule, safety, compliance, or patient supply. The Associate Specialist is expected to qualify on assigned processes within expected timelines, communicate reliably with the team, and build technical proficiency toward independent execution of core manufacturing processes.

Requirements

High school diploma with at least 2 years of GMP, laboratory, manufacturing, or relevant technical experience.
Basic understanding of cGMP requirements, aseptic technique, cleanroom procedures, and documentation practices.
Familiarity with cleanroom operations, equipment setup, regulated manufacturing, or laboratory environments.
Ability to follow detailed instructions and established procedures with strong attention to detail.
Ability to work effectively in a team-based manufacturing environment and learn on the fly.
Sound judgment to identify and escalate issues to senior team members.
Ability to prioritize assigned tasks and manage time effectively to support production schedules.

Nice To Haves

Associate degree or bachelor’s degree in science, engineering, or a related discipline, with 0–2 years of experience.
Experience in cell therapy, biologics, pharmaceutical, biotech, or vector manufacturing.
Experience working in a cleanroom or aseptic processing environment.
Experience with paper or electronic batch records, MES, inventory systems, or quality systems.
Familiarity with primary human cell culture, single-use technologies, or automated cell processing equipment.
Proficiency in Microsoft Word, Excel, and basic data entry or data review.

Responsibilities

Execute assigned manufacturing steps according to batch records, SOPs, electronic work instructions, and cGMP requirements.
Support GMP readiness activities, including equipment setup, cleanroom preparation, material staging, basic qualification support, and facility readiness.
Prepare, stage, verify, and transfer materials and consumables needed for manufacturing activities.
Monitor, clean, prepare, and operate automated or manual cell therapy processing equipment under guidance.
Follow gowning, cleaning, sanitization, aseptic technique, and contamination control procedures.
Maintain cleanroom standards and support area readiness, 5S, and housekeeping activities.
Maintain accurate, complete, and timely documentation in batch records, logbooks, electronic systems, and other production records.
Support batch record reconciliation and timely documentation closure as assigned.
Support material and component inventory control in manufacturing areas, including bill of material awareness and inventory transactions as assigned.
Escalate issues, errors, abnormal conditions, visible defects, or potential deviations in real time.
Provide factual input as requested for deviation, non-conformance, OOS, or quality record support.
Participate in shift handover communication and share relevant production information clearly.
Collaborate with Manufacturing, Quality, Process Development, MSAT, Supply Chain, EHS, and Facilities and Engineering as needed.
Support SOP drafting, document revisions, visual management, and continuous improvement activities under guidance.
Participate in required training and work toward qualification on assigned unit operations.
Perform or support Final Drug Product Visual Inspection activities when assigned, following site procedures and annual visual acuity qualification requirements.
Perform other responsibilities as assigned to support daily manufacturing operations and project goals.
Execute assigned tasks safely and compliantly, following approved procedures and batch records without unapproved variation.
Achieve qualification on assigned processes within expected timelines and demonstrate increasing technical proficiency toward independent execution of core processes.