Sacramento, CA, USA
Posted on Wednesday, September 27, 2023
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
Role & Responsibilities
The Manufacturing Research Associate is responsible for process optimization and Current Good Manufacturing Practice (cGMP) manufacturing activities in the production of cellular therapies in support of clinical studies, including:
• Faithfully execute standard operating procedures (SOPs)
• Use medical grade machinery
• Work with new technology
• Review and support continuous improvements of records and SOPs
• Maintain record keeping
• Participate and communicate effectively in a clean room manufacturing environment
• Instrument set-up and preparation, maintenance, troubleshooting, and operation
Education & Experience Requirements
- Minimum of high school diploma or GED
- A.S. degree and prior work experience in healthcare preferred, but not required
- Prior experience in manufacturing is not required
- Willingness and ability to work on a flexible schedule (may include swing and overnight shifts as needed) and to work in a Biosafety Level 2 (BSL-2) environment at our GMP facility in Sacramento
- This is a 24-hour operation and we will have a need to staff all 3 shifts
Personal Qualities & Physical Demands
- Highly detail oriented with special attention to quality and quality control, and possessing an interest in medicine
- Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
- Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
- Strong interpersonal skills and ability to communicate effectively
- Ability to work in a collegial and collaborative manner
- Ability to work independently and as part of a team
- Ability to work in a fast-paced start-up environment while following SOPs
- Highly tolerant and respectful of all team members
- A sense of humor is always appreciated
- Strong problem-solving skills with desire to improve upon established processes
- Must be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown
- Operate GMP and cleanroom manufacturing equipment
- Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
- Occasional need to ascend/descend stairs within work space; job requires standing/walking
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 patients who need them.
We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
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 department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.