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Senior Scientist, Quality Control, Microbiology

Orca Bio

Quality Assurance

Sacramento, CA, USA

Posted on Aug 27, 2025

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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.

The Senior Scientist, Quality Control, Microbiology will provide scientific and technical expertise in support of microbiological quality control for a GMP cell therapy production facility. This role is responsible for overseeing microbiological testing, environmental monitoring, method development/validation, and regulatory compliance to ensure the safety, sterility, and quality of cell therapy products. The Quality Control Senior/Principal Scientist, Microbiology performs meticulous assessment of contamination risks throughout the manufacturing process to uphold regulatory compliance and product integrity. The Senior Scientist will also act as a subject matter expert (SME) for microbiology-related investigations, support regulatory filings, and provide mentorship to junior QC and manufacturing staff.

Physical Demands

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.

Work Conditions

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.

Essential Duties & Key Responsibilities

Lead design and execution of viable and non-viable EM programs for cleanrooms, equipment, and personnel in compliance with USP, EP, and FDA/EMA guidelines.
Trend, analyze, and report EM and utility data; recommend corrective/preventive actions where appropriate
Lead validation and qualification of microbiological test methods in accordance with USP, Ph. Eur., ICH, and FDA guidance.
Author and review protocols, reports, and SOPs for microbiology methods and equipment
Serve as QC Microbiology SME during audits and regulatory inspections.
Lead or support laboratory investigations, root cause analysis, and implementation of CAPAs related to microbiological events.
Ensure data integrity, ALCOA+ principles, and compliance with GMP regulations.
Partner with Manufacturing, QA, Facilities, and MSAT to support contamination control strategies.
Mentor, train, and provide technical guidance to QC Microbiology and Manufacturing staff.
Contribute to continuous improvement of QC systems, workflows, and training programs.
Conduct contamination control risk assessments to identify potential sourcesof 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.
Identify and support resolution of technical problems.
Actively participate in group and project teamwork, project and process improvements.
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.

Minimum Requirements

Master’s or PhD in Microbiology, Biology, or related field preferred; Bachelor’s degree with extensive experience considered
Minimum 6–8 years of QC microbiology experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred).
Proven expertise in microbial testing, environmental monitoring, aseptic techniques, and contamination control.
Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP Annex 1; USP <61>, <62>, <71>, <85>, <1116>, <1117>, EP, ICH Q-series, FDA/EMA cell therapy guidance).
Strong understanding of contamination control principles and risk assessment methodologies.
Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines.
Strong leadership, mentoring, and team-building abilities.
Exceptional technical writing, data analysis, and problem-solving skills.
Effective communicator, capable of interacting with cross-functional teams and external auditors.
Comfortable in a fast-paced, dynamic environment supporting clinical and commercial manufacturing.
dhere to cGMP policies and procedures, including documentation activities
Willingness to work overtime as required
Able to wear appropriate personal protective equipment
Able to work collaboratively to respond to changing priorities and challenges
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

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.

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