What are the responsibilities and job description for the Process Development Scientist, CMC position at Orca Bio?
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.
Summary:
You will play a pivotal role in achieving process development and improvements which will be critical components of a biologics license application (BLA) submission milestones. You will lead and participate in studies and conduct wet lab evaluations of key unit operations across the cell therapy process. You may support or lead other work related to process characterization/validation, such as stability studies. You will focus on ensuring cell viability, purity, and potency throughout the process. Your work will be involved in all areas of both process and assay development, including product characterization, or method validation. The ideal candidate will possess a strong scientific background, attention to detail, and adaptability to evolving priorities. In addition, a background in scientific and technical writing for study and validation documentation is highly recommended. Previous experience in process characterization/validation is advantageous.
Key Responsibilities:
- Lead process characterization and process validation experiments and wet lab evaluations.
- Ensure cell viability, purity, and potency throughout the process.
- Conduct data analysis and contribute to scientific and technical documentation.
- Assist in data review for scientific integrity.
Required Qualifications:
- Experience in a lab environment, preferably in process development.
- Strong scientific principles and understanding of biologics/cells.
- Familiarity with process characterization/validation and regulatory requirements.
Preferred Qualifications:
- Experience with cell therapy processes and selection mechanisms.
- Previous exposure to late-stage process development and CMC.
- Regulatory compliance experience.
- Prior experience with MACS and/or FACS.
- PhD in Chemical Engineering, Immunology, Biochemistry, or a related scientific discipline.
The anticipated annual salary range for this U.S. based job is $80,000– $100,000. 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.
\nWho 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.
To learn more: https://orcabio.com/join-our-team/
**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.
Salary : $80,000 - $100,000
