Associate, Cell Therapy Production, 1st Shift

Orca Bio•Sacramento, CA

6h•Onsite

About The Position

The Associate, Cell Therapy Production supports production of Orca Bio’s cell therapy products in a highly regulated environment. The role repeatedly executes manufacturing processes, cleans and maintains production equipment and workstations, and documents production activities while following quality standards, regulatory requirements, aseptic techniques, SOPs, batch records, and cGMP practices. The Associate works cross-functionally with Materials Management, Quality Control, and Quality Assurance to carry out manufacturing runs. This is an on-site day-shift role, Monday through Friday, 7:00 a.m. to 3:00 p.m. The employee may work at either Orca Bio Sacramento location—3400 Business Drive or 7910 Metro Air Parkway—based on operational needs. Scheduled overtime, weekend or holiday work may be required based on business needs, and the role participates in an on-call rotation as needed for weekend and/or holiday shifts.

Requirements

Bachelor of Science degree in biology or a related field.
1–2 years of experience in process sciences, discovery research, or manufacturing.
Experience with aseptic techniques.
Visual acuity of 20/20, corrected or uncorrected, and normal color vision.
Ability to meet cleanroom gowning requirements, including wearing full gowning for up to three consecutive hours, with minimal movement in the cleanroom.
Comfort working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays.
Ability to work at either Sacramento location based on operational needs.
Ability to work scheduled overtime, weekends, or holidays as required by business needs.
Willingness to participate in an on-call rotation as needed for weekend and/or holiday shifts.
Comfort regularly participating in video-based meetings.
Comply with cleanroom restrictions on cosmetics, jewelry, and facial piercings, and disclose skin conditions that cause shedding.
Strong attention to detail, particularly regarding quality and documentation.
Strong work ethic and willingness to learn and contribute in a fast-paced, collaborative environment.
Excellent interpersonal skills and effective communication.
Ability to work independently and collaboratively.
Tolerance and respect for all team members.

Nice To Haves

Master of Science degree in biology or a related field.
Prior experience in GMP and lab-scale manufacturing, including validation and quality systems.
Familiarity with cell or gene therapy, human cells, cell characterization methods, and cell sorting and analysis.

Responsibilities

Operate and closely monitor advanced manufacturing equipment to support production of 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 them to management as necessary.
Complete assigned training to maintain technical proficiency and adhere to cGMP standards.
Operate, monitor, clean, and prepare automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments.
Contribute to continuous improvement efforts involving manufacturing efficiency and compliance practices.
Support investigations, deviations, and change control processes.
Clean and maintain production equipment and workstations and document production activities.
Collaborate with Materials Management, Quality Control, and Quality Assurance on GMP manufacturing runs.
Participate in an on-call rotation as needed for weekend and/or holiday shifts.