Orca Bio Sacramento , CA 94204
Posted 2 weeks ago
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.
Responsibilities:
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
General Requirements:
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
Senior Qualifications:
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
Principal Qualifications:
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
The anticipated annual salary for this U.S. based job is $100,000- $160,000. The final offer will be based on professional experience previously in this role/industry, education, geographic location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company's sole discretion.
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.
Orca Bio