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.

The (Sr./Principal, depending on experience) QC Scientist, Method Validation will lead our method validation efforts, conduct routine and non-routine analysis, including but not limited to biochemical and chemical analysis of processes leading up to drug product, according to established operating procedures. In this role, you will also: compile data for documentation of test procedures; calibrate and maintain lab and analytical equipment; participate in the preparation of investigations, summaries and reports; review data obtained for compliance to specifications and report abnormalities; revise and update standard operating procedures as needed; and perform special projects. The desired candidate has prior experience talking with the FDA about a method validation.

·       Perform routine quality control testing on raw materials, process intermediates, and final cell therapy products using established protocols

·       Perform a broad variety of basic and moderate complex tests in support of lab operations, including but not limited to flow cytometry and other cell-based assays

·       Record and document all quality control testing activities accurately and in compliance with cGMP regulations and company procedures

·       Assist in the preparation and review of batch records, standard operating procedures (SOPs), and other relevant documentation.

·       Perform routine lab maintenance, including equipment qualification/maintenance

·       Prepare basic and complex reagents as assigned

·       Order and maintain lab supply inventory

·       Aliquot samples as required, including aseptic aliquoting

·       Participate in assay transfer and assay validation

·       Identify and support resolution of technical problems

·       Actively participate in group and project teamwork; project and process improvements.

·       Receive and provide training

·       Perform other duties as requested by supervisor/manager to support Quality

·       Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products

·       Communicate effectively with team members and contribute to a positive and collaborative work environment

·       Actively participate in group and project teamwork; project and process improvements

·       Strong organizational skills and the ability to manage multiple tasks concurrently

·       Willingness to learn and adapt in a fast-paced, dynamic environment

·       Adhere to cGMP policies and procedures, including documentation activities

·       Willingness to work overtime as required

·       Able to wear appropriate personal protective equipment

·       Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 4-10 years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree with 2-5 years of experience; OR a PhD in a relevant scientific discipline with 0-2 years of experience.

·       Demonstrated understanding of analytical techniques, laboratory equipment, and quality control principles

·       Strong experience in aseptic technique, flow cytometry, or cell-based assays

·       Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred

·       Reliably able to contribute to decision making in areas of expertise

·       Able to lead project and testing timelines

·       Detail-oriented with a strong commitment to data integrity and accuracy, with ability to identify and solve problems with data management

·       Adaptable and responsive to changing priorities and challenges

·       Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment

·       Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 10-15 years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree with 4-8 years of experience; OR a PhD with 2-4 years of experience.

·       Consistently demonstrated understanding of analytical techniques, laboratory equipment, and quality control principles

·       Strong experience in aseptic technique, flow cytometry, or cell-based assays

·       Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is required.

·       Ability to make and communicate difficult and complex decisions independently

·       Able to lead independent project and testing timelines and contribute to interdisciplinary project goals

·       Detail-oriented with a strong commitment to data integrity and accuracy, with ability to identify and solve problems with data management independently

·       Adaptable and responsive to changing priorities and challenges

·       Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment

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.

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.