Orca Bio

Specialist, Production Project Support

Sacramento, CA · Full-time

Sponsorship not specified$70k-$95kDetected 19 days ago

Project ManagementProcess ImprovementGMPFDA RegulatoryLeadershipCommunicationCollaborationLean Manufacturing

About the role

More than one million people in the United States today are fighting blood cancer.
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.

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.
Maintain accurate records of change implementation and outcomes.
Support the execution and documentation of corrective and preventive actions, including follow-up activities.
Draft, revise, and maintain SOPs in collaboration with subject matter experts.
Schedule and facilitate cross-functional meetings as needed to support project deliverables.
Maintain accurate and organized project documentation.

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
Domestic and international travel not required.

Project management knowledge is a plus.
Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred.
PMP Certification or equivalent formal project management training is preferred
Familiarity with Lean Six Sigma or operational excellence methodologies is a plus

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.

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.

This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.