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. 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.
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 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

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.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 2+ years of experience in a GMP-regulated biotech or pharmaceutical environment.
• Project management knowledge is a plus.
• Strong understanding of cell therapy, biotech or pharmaceutical manufacturing processes 
• Proven track record of successfully implementing improvement projects
• Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred.
• Excellent communication, leadership, and organizational skills.
• PMP Certification or equivalent formal project management training is preferred
• Familiarity with Lean Six Sigma or operational excellence methodologies is a plus

Travel Requirements and Work Environment

• Domestic and international travel not required. 
• 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.

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. 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.   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.