Manufacturing Associate
Sacramento, CA
Manufacturing – Manufacturing /
Regular, Full-Time Employee /
On-site
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.
Summary:
The Manufacturing Research Associate helps optimize processes and conducts cGMP manufacturing activities to produce our cell therapies in support of clinical studies, which in turn allow us to secure FDA approval, scale, and serve more patients.
Because manufacturing for clinical studies requires significant coordination with hospital sites, donors, and patients, we need dedicated team members who understand that timing is everything - we literally hold patient cells in our hands. If you're willing and eager to roll-up your sleeves and work on a flexible schedule (including occasional graveyard shifts to process cells) in a BSL-2 environment, you're meant to be on our team!
Location: 3400 Business Dr, Suite 140 Sacramento, CA 95820 (Clinical Manufacturing Facility)
Required Qualifications
- Master’s or bachelor’s degree in biology or related field
- 1-2 years of experience in process sciences, discovery research or manufacturing
- Experience with aseptic techniques
- Breadth of knowledge of cell therapy and clinical manufacturing, cell processing technologies, cell characterization methods, validation and quality systems
Responsibilities
- Faithfully execute scientific protocols
- Develop cell therapy for blood diseases
- Optimize cell assays
- Use cell separation technologies
- Perform flow cytometry and analyze data
- Work with new technology
- Review and support continuous improvements of records and SOPs
- Analyze results, maintain detailed records of experiments and outcomes
- Participate in group research discussions
- Prepare, maintain, trouble-shoot, and operate instruments
- Participate in group research discussions
- Other duties as assigned, from time to time, e.g. performing quality control, etc.
Desired Qualifications
- A background in immunology, oncology or cell therapy
- Flow cytometry experience, including sorting and analyzing cells
- Experience working with human cells
- GMP experience and/or eagerness to learn the manufacturing process under GMP
- Highly detail-oriented, and pays special attention to quality and quality control
- A multi-tasker who can handle and prioritize multiple responsibilities simultaneously
- Curious to learn and eager to step-up immediately in a fast-paced, collaborative start-up environment
- Able to work both independently and as part of a team, and seamlessly transition between the two
- Strong problem-solving skills with the desire to improve upon established processes
- Eager to onboard, train, and mentor new team members
- A sense of humor is always appreciated
Other Requirements
- 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
- 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 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.
