About this opportunity
Orca Bio lists this Scientist, Quality Control - Night Shift opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job 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.
Scientist, Quality Control - Night Shift
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
Physical Demands & Work Conditions
Production Associates: 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 meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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 comfortable regularly participating in video-based meetings.
$65,000 - $95,000 a year
The night shift receives a +7% night shift differential.
The anticipated annual salary range (listed above) 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.
pre-IPO equity and annual bonus
competitive medical, dental, and vision benefits
PTO
401(k) plan
life and accidental death and disability coverage
parental leave benefits
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.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.