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 CMC Regulatory Lead (~Director level) 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 Regulatory Affairs. 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 requires a strong scientific background with understanding and experience in cGMP manufacturing, analytical practices, and relevant regulatory guidelines.
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 (e.g., BLA) to meet overall program objectives/milestones.
The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
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.
