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 MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
Essential Duties & Key Responsibilities:
Performs ongoing monitoring of existing products and processes
Generate metrics and reports for process monitoring and continuous process verification
Support process improvements and changes including electronic batch record creation and modifications
Investigates process events and implements corrective and preventive actions
Provides troubleshooting support for manufacturing events, equipment performance and material issues
Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities
Minimum Qualifications:
B.S. in Engineering or similar fields
3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
Prior experience in regulated, GMP manufacturing operations
Experience in biotechnology and cell therapy manufacturing preferred
Strong communication and problem solving skills, with a desire to improve upon established processes
Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
3rd Shift:
• Monday - Friday, 12:00am - 8:30am
Physical Demands
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
