Associate, Cell Therapy Production, 1st Shift

The Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.

This is a day shift-based position, working on-site Monday through Friday, from 7:00am to 3:00pm.

Physical Demands

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Work Conditions

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

Essential Duties & Key Responsibilities

• Operate and closely monitor advanced manufacturing equipment to support the production of cutting-edge cell therapy products
• Follow and execute standard operating procedures (SOPs) and batch records to perform production activities
• Identify and resolve equipment or process issues, escalating to management as necessary
• Complete all assigned training to maintain required technical proficiency and adhere to cGMP standards
• Operate, monitor, clean, and prepare advanced automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments. All required PPE and GMP-compliant gowning are provided by the company
• Contribute to continuous improvement efforts, including manufacturing efficiency, compliance practices, and support for investigations, deviations, and change control processes
• Required to participate in an on-call rotation as needed for weekend and/or holiday shifts

Minimum Qualifications

• B.S. degree required in biology or related field
• 1-2 years of experience in process sciences, discovery research of manufacturing
• Experience with aseptic techniques

Preferred Qualifications

• M.S. degree in biology or related field
• Prior experience in GMP and lab-scale manufacturing, including validation and quality systems
• Familiarity with cell/gene therapy, including working with human cells, cell characterization methods, sorting and analyzing cells
• Aseptic techniques

Personal Qualities

• Highly detail oriented with special attention to quality and documentation
• Strong work ethic, curiosity to learn and contribute in a fast-paced, collaborative environment
• Excellent interpersonal skills and ability to communicate effectively
• Ability to work both independently and in a collaborative manner
• Highly tolerant and respectful of all team members
• A sense of humor is always appreciated