Manufacturing Associate I at NKGen Biotech – Santa Ana, California

Job Summary

The Manufacturing Associate I will support the successful tech transfer and operational readiness process. Primary responsibilities are to ensure the successful completion of cGMP batch manufacturing and release of cell therapy products. Promote a culture of Safety, Quality and Compliance mindset. Ensure all processes and procedures related to the job description are followed in full compliance with cGMP, CFRs and site quality systems, policies, and procedures. The MFG Associate I will be part of a cohesive team responsible for the quality manufacturing of our products, have a “right the first time” mindset.

General Responsibilities

• Perform all tasks associated with the manufacturing of clinical drug product and follow the instructions described in standard operating procedures, protocols, test records, training records and batch records.
• Accurate and timely completion of documentation generated and required by protocols, test runs, training runs, standard operating procedures, and batch records.
• Adhere to tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Completion of training runs in a timely manner and uninterrupted to evaluate the necessary technical skills and aptitude for development.
• Work as part of a dedicated and committed team to execute cGMP production runs in close collaboration with support business units.
• Adhere and maintain aseptic technique practices during processing of products to ensure the integrity, viability, and sterility of finish drug product.
• Required to work in a cleanroom environment (ISO5/7) for prolonged periods of time; specialized gowning such as double gloves, hair net, masks, safety glasses, sterile coveralls and shoe covers.
• Ability to perform cell counting (manual/automated), perform error free calculations of cell concentrations, dilutions a plus.
• Flexible and adaptable to production schedule needs, procedural changes, batch record enhancements to ensure timely production is met.

*The company reserves the right to add or change duties at any time.

Education

• BS degree in relevant Science or Engineering discipline preferred.
• AA degree in relevant Science or Engineering discipline, plus 2 years experiences in biotech/pharma.
• High School diploma with 4 years biotech/pharma experience.

Job Qualifications & Skills

• Cell culture processing experience, in handling and propagation of human primary cell a plus.
• Ability to be flexible, work off-shifts and extended hours as required.
• Capability to lift over 20lbs
• Weekend work, holidays and/or overtime may be required.
• cGMP experience in preferably a pharmaceutical / biotechnology or similar manufacturing environment.
• Skilled in Microsoft Word, Excel and data analysis.

Benefits & Perks

• Competitive compensation
• Medical, Dental and Vision Insurance
• Business casual work attire
• Fully stocked kitchen and much more!