Scientist, Quality Control - Night Shift

About the Role

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. The Scientist, Quality Control - Night Shift conducts routine and non-routine analysis, including biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. This role supports the consistent and reliable delivery of high-precision cell therapy products from our state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA.

Responsibilities

• Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols.
• Perform a broad variety of basic and moderate complex tests in support of lab operations, including flow cytometry and other cell-based assays.
• Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures.
• Assist in the preparation and review of batch records, standard operating procedures (SOPs), and other relevant documentation.
• Perform routine lab maintenance, including equipment qualification and maintenance.
• Prepare basic and complex reagents as assigned.
• Order and maintain lab supply inventory.
• Aliquot samples as required, including aseptic aliquoting.
• Participate in assay transfer and assay validation.
• Identify and support resolution of technical problems.
• Actively participate in group and project teamwork; project and process improvements.
• Receive and provide training.
• Perform other duties as requested by supervisor/manager to support Quality.
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.

Requirements

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) required.
• 2-4 years of experience in quality control testing, analytical development, or biologics GMP preferred; candidates with less experience may be considered for Associate Scientist role. Master's degree may substitute for years of experience.
• Moderate understanding of analytical techniques, laboratory equipment, and quality control principles.
• Some experience in aseptic technique, flow cytometry, or cell-based assays.
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred.
• Communicate effectively with team members and contribute to a positive and collaborative work environment.
• Strong organizational skills and the ability to manage multiple tasks concurrently.
• Willingness to learn and adapt in a fast-paced, dynamic environment.
• Adhere to cGMP policies and procedures, including documentation activities.
• Able to wear appropriate personal protective equipment.
• Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management.
• Able to work collaboratively to respond to changing priorities and challenges.
• Able to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment.

Schedule

• 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.

Physical Demands

• 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.

Work Conditions

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

Pay

$65,000 - $95,000 a year. The night shift receives a +7% night shift differential. 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.

Benefits

• Pre-IPO equity and annual bonus for full-time employment positions.
• Competitive medical, dental, and vision benefits.
• PTO (Paid Time Off).
• 401(k) plan.
• Life and accidental death and disability coverage.
• Parental leave benefits.
• Subsidized daily lunches and snacks at on-site locations.

About Us

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.