Associate Specialist, Cell Therapy

The primary purpose of this role is to support 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 is expected to recognize when an activity, condition, or observation may differ from accepted practice and escalate appropriately.

Typical Accountabilities

• 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 required for manufacturing activities.
• Routinely monitor, clean, prepare, and operate automated or manual cell therapy processing equipment under guidance.
• Follow proper gowning, cleaning, sanitization, aseptic technique, and contamination control procedures.
• Maintain cleanroom standards and support routine 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 within 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.
• Participate in deviation, non-conformance, OOS, or quality record support by providing factual input as requested.
• Participate in shift handover communication and ensure relevant production information is shared 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, in accordance with site procedures, including annual visual acuity qualification.
• Perform other responsibilities as assigned to support daily manufacturing operations and project goals.

You Are Accountable For

• Safe and compliant execution of assigned manufacturing tasks.
• Following approved procedures and batch records without unapproved variation.
• Accurate, complete, and timely documentation.
• Timely escalation of issues that may impact product quality, schedule, safety, compliance, or patient supply.
• Maintaining cleanroom discipline and contamination control expectations.
• Achieving qualification on assigned processes within expected timelines.
• Supporting team performance through reliable execution and communication.
• Demonstrating increasing technical proficiency and progress toward independent execution of core manufacturing processes.

Minimum Qualifications

• High School Diploma with at least 2 years of GMP, laboratory, manufacturing, or relevant technical experience. Associate degree or Bachelor degree in science, engineering, or a related discipline with 0-2 years experience is preferred.
• 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.

Preferred Qualifications

• Cell therapy, biologics, pharmaceutical, biotech, or vector manufacturing experience.
• 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.