- Salary
- $65k – $95k/yr
- Location
- Sacramento, CA
- Workplace
- Onsite
- Type
- Full-time
- Department
- Quality
- Experience
- 2+ years
- Education
- Master
- Source
- Lever
Description
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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Scientist, Quality Control - Night Shift conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. Compiles data for documentation of test procedures. Calibrates and maintains lab and analytical equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects.
Specific 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 but not limited to 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/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
General Requirements:
- Communicate effectively with team members and contribute to a positive and collaborative work environment
- Actively participate in group and project teamwork; project and process improvements
- 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
Desired Experience:
- 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
- Able to meet project and testing timelines
- 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
- Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated 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
Skills
GMPCompliance
