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.
This position will be responsible for developing and executing innovative regulatory strategies in support of the chemistry, manufacturing, and controls (CMC) development for our early to late stage development pipeline products within the Regulatory Affairs department. In this lead, direct role, the successful candidate will provide dynamic leadership and direction to senior management and product development teams and will work in close partnership with the CMC/Quality leadership to achieve development milestones in an efficient and compliant manner. The role would require a strong scientific background with understanding and experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines to contribute to and shape the overall manufacturing strategy.
The successful candidate will interface cross-functionally in a matrixed environment to integrate CMC plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
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, inquires and offers are managed through our HR/Talent department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.
