Orcabiosystems4mo ago

USD 65465–71571/yr

Associate, Packaging Operations and Cold Chain Handling - Night Shift

United States·SacramentoRegular, Full-Time Employeemid

OtherAssociate

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OtherAssociate

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 vs. host disease. Orca Bio is a commercial-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.

The Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.

Night Shift Hours Worked:

• 6:00pm to 6:30am or

• 6:30pm to 7:00am

Work Week Schedule:

• Sunday, Monday, Tuesday + every other Wednesday or

• 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, as needed. 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 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.

Blood Intake & Chain-of-Identity Management:

Receive and verify incoming apheresis materials according to SOPs and regulatory requirements.

Perform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging.

Maintain strict adherence to chain-of-identity and chain-of-custody procedures.

Cryopreservation Support:

Assist in the preparation and cryopreservation of intermediate and final cellular products.

Operate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks).

Accurately complete batch records and electronic documentation systems.

Drug Product Shipment:

Coordinate the labeling, packaging, and final release of drug product for shipment.

Prepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners.

Ensure real-time data entry into inventory, tracking systems and eBRs

Perform other duties as assigned

Work closely with Quality Assurance, Supply Chain, and Manufacturing teams to ensure timely and compliant operations.

Support deviation investigations, CAPAs, and continuous improvement initiatives as needed.

Maintain accurate and complete records in accordance with GMP and GDP standards.

Good Manufacturing Practices (GMP) Training

Bachelor’s degree in Life Sciences, Engineering, or related field preferred.

1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred.

Strong understanding of cell therapy manufacturing processes

Strong attention to detail, organizational skills and document accuracy.

Ability to work with biological materials and cryogenic systems

Knowledge of regulatory compliance (FDA and GxP) a plus

Comfortable working in a clean room and or cold environment (Liquid Nitrogen storage)

Domestic and international travel not required

May involve standing for extended periods and lifting up to 25 lbs

Shift work, weekends, or holidays may be required depending on production needs

Exposure to human blood products and temperature-controlled storage areas

Gowning and use of Personal Protective Equipment required

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.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

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.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.