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Commercial Manufacturing Operator, 3rd Shift
Orca Bio
Sacramento, CA, USA
Posted on Jul 20, 2024
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.
The Manufacturing Operator plays a critical role in the production of Orca Bio’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves executing manufacturing processes, cleaning and maintaining production equipment and workstations, and documenting production activities in a highly regulated environment. This position is for 3rd shift, working on-site, Monday through Friday from 11pm to 7:30am, at 7910 Metro Air Parkway, Sacramento, CA.
Responsibilities
- Operate and monitor equipment used in the production of cell therapy products
- Follow and execute standard operating procedures (SOPs) and batch records to perform production activities
- Use medical grade machinery
- Adhere to good manufacturing practices and good documentation practices
- Participate and communicate effectively in a clean room manufacturing environment
- Perform Instrument set-up, cleaning, change over, maintenance, troubleshooting, and operation
Education & Experience Requirements
- Minimum of high school diploma or GED
- A.S. degree is preferred, but not required
- Prior experience in GMP manufacturing, lab scale manufacturing preferred
- Cell and gene therapy knowledge is beneficial
Personal Qualities & Physical Demands
- Ability to gown and work in clean rooms and Biosafety safety cabinets
- Highly detail oriented with special attention to quality
- 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 collaborative manner, independently and as part of a team
- Highly tolerant and respectful of all team members
- A sense of humor is always appreciated
- Strong problem-solving skills
- 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
- 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 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.
To learn more: https://orcabio.com/join-our-team/
**all official communication will be from @orcabio.com; please beware of scams**
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.