Specialist, Production Project Support

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 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. Specialist, Production Project Support The Specialist, Production Project Support supports the execution and documentation of business process improvements, change controls, CAPA initiatives, and the development and maintenance of Standard Operating Procedures (SOPs). This role works cross‑functionally with production, quality assurance, engineering, and continuous improvement teams to ensure timely and compliant execution of changes and improvement projects within a regulated manufacturing environment. Physical Demands Production Associate Roles: 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. Most roles 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 Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video‑based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs. Essential Duties & Key Responsibilities Assist in the identification, documentation, and implementation of business process improvements to enhance efficiency, quality, and cost‑effectiveness. Coordinate data collection and analysis to support root cause investigations and improvement initiatives. Support the preparation, tracking, and execution of change control documentation in compliance with quality and regulatory standards. Ensure all impacted stakeholders are involved in the review and approval of changes. Maintain accurate records of change implementation and outcomes. Support the execution and documentation of corrective and preventive actions, including follow‑up activities. Assist in CAPA investigations by compiling data, organizing cross‑functional meetings, and tracking completion of action items. Ensure CAPA documentation meets internal and regulatory expectations. Draft, revise, and maintain SOPs in collaboration with subject matter experts. Ensure SOPs reflect current best practices and regulatory requirements. Facilitate training rollout and ensure personnel are informed of updated procedures. Track progress of ongoing production‑related projects and report on milestones, issues, and risks. Schedule and facilitate cross‑functional meetings as needed to support project deliverables. Maintain accurate and organized project documentation. On‑site presence required, especially during critical project phases or production support. May involve gowning and working in classified cleanroom environments, including no jewelry, makeup, etc. Occasional off‑hours or weekend work depending on project needs. Minimum Qualifications Bachelor’s degree in Life Sciences, Engineering, or related field. 2+ years of experience in a GMP‑regulated biotech or pharmaceutical environment. Strong understanding of cell therapy, biotech or pharmaceutical manufacturing processes. Proven track record of successfully implementing improvement projects. Excellent communication, leadership, and organizational skills. Preferred Qualifications Project management knowledge is a plus. PMP Certification or equivalent formal project management training is preferred. Familiarity with Lean Six Sigma or operational excellence methodologies is a plus. Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred. $70,000 - $90,000 a month 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, 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. 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. #J-18808-Ljbffr Medium