Scientist, Quality Control, Microbiology

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 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.

We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.

Orca Bio is seeking a skilled Quality Control Scientist, Microbiology to ensure the highest standards of quality and safety in our biotechnological processes. As a key member of our team, you will be responsible for conducting comprehensive microbiological analyses, identifying potential contamination risks, and implementing robust control measures. Your role will involve meticulous assessment of contamination risks throughout the manufacturing process to uphold regulatory compliance and product integrity.

• 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 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.

• Perform microbiological testing on raw materials, in-process samples, and finished products to detect and quantify microbial contamination.
• Develop and validate microbiological testing methods, ensuring accuracy, precision, and reproducibility.
• Conduct contamination control risk assessments to identify potential sources of microbial contamination in the manufacturing environment.
• Implement and maintain effective contamination control strategies, including environmental monitoring programs and cleaning validation protocols.
• Collaborate with cross-functional teams to investigate and resolve microbiological deviations, implementing corrective and preventive actions as necessary.
• Support regulatory compliance by ensuring adherence to relevant quality standards, including cGMP, ISO, and FDA guidelines.
• Provide technical expertise and guidance to manufacturing personnel on microbiological best practices and contamination control measures.
• Stay abreast of emerging trends and advancements in microbiological testing methodologies, incorporating relevant innovations into quality control processes.
• Manage microbiological testing on raw materials, in-process samples, and finished products to detect and quantify microbial contamination.
• 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
• 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.

• Bachelor's or Master's degree in Microbiology or in a relavant scientific discipline.
• Minimum of 5+ years of experience in microbiological quality control within the biotechnology or pharmaceutical industry is preferred.
• Proficiency in microbiological testing techniques, including sterility testing, endotoxin analysis, and microbial enumeration.
• Experience in aseptic techniques.
• Demonstrated knowledge of cGMP, ISO, and FDA guidelines for environmental monitoring and microbiology
• Strong understanding of contamination control principles and risk assessment methodologies.
• Experience with regulatory requirements for biopharmaceutical manufacturing, including cGMP and FDA guidelines.
• Excellent analytical skills with meticulous attention to detail.
• Effective communication skills with the ability to collaborate across interdisciplinary teams.
• Adhere to cGMP policies and procedures, including documentation activities.
• Willingness to work overtime as required.
• Able to wear appropriate personal protective equipment.
• 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.
• 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.

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. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free 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.