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 Project Manager, Operations facilitates and leads cross-functional projects within a commercial cell therapy manufacturing facility. This role is responsible for managing key initiatives across manufacturing, tech transfer, facility expansions, quality and compliance, and continuous improvement activities. The project manager will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to manage complex, time-sensitive projects in a fast-paced environment.
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 cross-functional project teams for initiatives supporting site operations, including business process improvements, strategic needs and capacity expansion.
- Act as the primary liaison between manufacturing, quality, supply chain, engineering, MS&T (Manufacturing Science & Technology), and regulatory affairs as needed to coordinate projects.
- Develop and maintain detailed project plans, timelines, budgets, and resource allocations.
- Track project progress against milestones, proactively identifying and mitigating risks or delays.
- Facilitate and document project meetings, action items, and key decisions.
- Support and execute project plans to desired timelines and key milestones.
- Coordinate readiness activities for project implementation and follow up, including training, SOP updates, validation, and monitoring project effectiveness.
- Ensure compliance with GMP, regulatory standards, and internal quality systems throughout project execution.
- Present project updates to stakeholders and senior leadership; ensure alignment across all levels.
Minimum Experience, Education, Certifications, Licenses
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 5+ years of experience in a GMP-regulated biotech or pharmaceutical environment, with at least 2 years in project management.
- Strong understanding of cell therapy manufacturing processes
- Proven track record of successfully managing operations, technical, or capital projects in a regulated environment.
- Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products.
- Experience working in commercial stage / post-launch biotech or pharma preferred
- Proficient in project management tools (e.g., MS Project, Smartsheet, or equivalent).
- Excellent communication, leadership, and organizational skills.
- PMP Certification or equivalent formal project management training, preferred
- Familiarity with Lean Six Sigma or operational excellence methodologies a plus
- Advanced degree (MS, MBA) or certification in life sciences, engineering, or business a plus
- Project /Program management training preferred.
Travel Requirements and work environment
- Domestic and international travel may be required from time to time as needed (<10%).
- 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. 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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