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 Regulatory CMC Manager will be responsible for authoring and preparing regulatory packages in support of the chemistry, manufacturing, and controls (CMC) development for our early- to late-stage development pipeline products. The successful candidate will support the development and execution of regulatory strategies within Regulatory Affairs, working closely with CMC and Quality teams to ensure alignment with development milestones and regulatory compliance. This role requires a strong scientific background with experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines.
The successful candidate will work cross-functionally in a matrixed environment to integrate CMC plans with overall development plans, ensuring the preparation of timely and high-quality regulatory submissions (e.g., BLA) to meet program objectives.
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.
**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.
