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Cell Therapy Production Associate, Oncology - Night Shift

Orca Biosystems Inc.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease. Orca Bio is a late‑stage biotechnology company redefining the transplant process by developing next‑generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high‑precision investigational cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives. Cell Therapy Production Associate, Oncology – Night Shift Plays a critical role in the production of Orca Bio’s life‑saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, the job 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. Night Shift Hours Worked 6:00 pm to 6:30 am 6:30 pm to 7:00 am Work Week Schedule Sunday, Monday, Tuesday + every other Wednesday Thursday, Friday, Saturday + every other Wednesday Production Associate Roles 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 be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods; use of cosmetics, 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. Daily overtime and potential weekend and holiday work are required. 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. Qualifications Associate degree and at least one year of experience in biomanufacturing, OR High School Diploma/GED with a minimum of two years of biomanufacturing experience. Experience working in GMP‑compliant environments. Involvement in investigations, deviations, and change‑control processes. B.S. degree in Biological or related sciences. 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. Benefits The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job‑related factors as permitted by law. For remote‑based positions, this range may vary based on your local market. Full‑time employment positions will also be eligible to receive pre‑IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on‑site locations. We’re proud to be an equal‑opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. #J-18808-Ljbffr

Vacancy posted 8 hours ago
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