Cellular Therapy Manufacturing Associate

About iCell Gene Therapeutics:

iCell Gene Therapeutics is a pioneering biotechnology company developing first-in-class CAR T therapies for autoimmune diseases and cancer. With clinical programs in the U.S. and China, we design and manufacture innovative cell therapies that address major unmet medical needs. Backed by an extensive global IP portfolio and a worldwide clinical dataset for CAR treatments, iCell is advancing breakthrough CAR T cell therapies, including the first CAR therapy to induce long-term remission in lupus.

At iCell, you’ll join a mission-driven team dedicated to transforming the treatment of autoimmune diseases and cancer by targeting their root cause and delivering durable, life-changing outcomes for patients. We are committed to scientific excellence, global collaboration, and rapid innovation to bring novel therapies to those that need them most.

Position Summary:

We are seeking a Cellular Therapy Manufacturing Associate who is responsible for performing manufacturing operations to support the production of CAR T Cell therapies in accordance with current Good Manufacturing Practices (cGMP). In this role, the associate will follow established SOPs, maintain accurate batch records, and uphold quality and safety standards throughout the production process. The role requires hands-on aseptic processing, routine cell culture and the operation of GMP equipment to ensure quality and reproducibility of manufacturing runs.

Key Responsibilities:

• Perform aseptic techniques in a GMP environment.
• Follow and execute Standard Operating Procedures (SOPs) for cellular therapy manufacturing and train others on basic SOPs, equipment and processes.
• Perform cellular therapy manufacturing tasks in compliance with applicable regulations, International Standards, and iCell Policies and Standard Operating Procedures.
• Able to operate and maintain equipment.
• Prepare solutions, reagents, and materials according to established procedures.
• Utilize basic technical knowledge to support daily manufacturing activities.
• Assist in execution of validation studies and associated documentation.
• Receive and organize materials as needed for production and identify material discrepancies promptly.
• Execute Batch Records (BRs) and contribute to revisions and approvals.
• Use applicable support systems to manage data and documentation.
• Collaborate with supporting departments as needed to facilitate manufacturing activities.
• Accurately collect, document, and record scientific and process data following good document practices.
• Adhere to all regulatory, compliance, and GMP requirements.
• Support the development of technical documents, including deviation reports and non-conformance documentation.
• Identify improvement ideas and help troubleshoot operational issues.
• Participate in regulatory inspections and audits as required.
• Uphold professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Contribute to department objectives and overall operational success.

Knowledge, Skills & Ability:

• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
• Strong understanding of manufacturing workflows, processes, and operations.
• Able to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Must be able to perform effectively under direct supervision.
• Must wear appropriate clean room attire and all Personal Protective Equipment (PPE).
• Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
• Holiday and shift work often required based on manufacturing schedule as determined by Management.
• Proficient in oral and written communication skills, with the ability to read, write, and understand English.
• Proficient in Microsoft (Excel, Word, Outlook)

Education:

• Bachelor’s degree (biological sciences preferred) with at least 2 years of experience.

Experience:

• Hands on cellular therapy manufacturing experience (at least 2 years).
• Experience operating in controlled environments under GMP regulations.
• Extensive experience in tissue culture and aseptic technique.

Disclaimer:

The information provided in this job description reflects the general scope and nature of the work expected. IT is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the role. Assigned tasks and responsibilities may be modified at any time, with or without notice.