Lead cGMP manufacturing activities for clinical and commercial cell therapies at Orca Bio's East Coast facility.
Posted by employer 1 month ago
First seen on Joblaze 1 week ago
Last verified on the company career page 1 day ago
Not disclosed in this posting: compensation, years of experience, visa sponsorship.
Joblaze summary
The Manufacturing Process Lead is responsible for overseeing cGMP manufacturing activities to produce clinical and commercial cell therapies, ensuring adherence to quality standards and regulatory requirements. Key skills include expertise in aseptic production techniques and process optimization, along with a strong focus on documentation and equipment maintenance. This role is well-suited for individuals with a solid background in biotechnology or manufacturing, particularly those with experience in regulated environments. Orca Bio is in a critical phase of establishing its East Coast operations, which are vital for advancing its innovative cell therapy pipeline.
Quick facts
- Is the Manufacturing Process Lead (3rd Shift) role remote?
- No — this is an on-site role in Princeton, NJ.
- Where is the role based?
- Orca Bio is hiring for this position in Princeton, NJ.
- What seniority level is this role?
- Orca Bio targets lead candidates for this position.
- Is this full-time or contract?
- Full-time for this Manufacturing Process Lead (3rd Shift) role at Orca Bio.
From the original posting
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.
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives.