Manager, Manufacturing Sciences & Technology (MSAT)

SacramentoRegular, Full-Time Employeemid

OtherManufacturing

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Overview

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,

Technical Tools

OtherManufacturing

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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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 Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.

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.

Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Lead a small team of engineers and technical experts

Provide leadership and guidance in technical decision-making related to manufacturing operations

Manage review and approval of quality records owned or supported by MSAT

Implement process improvements based on data analysis and scientific principles

Lead efforts in production excellence to support commercial scalability and compliance

Support the transfer of processes from R&D into GMP manufacturing facilities

Collaborate with cross functional teams to trouble shoot and resolve technical issues

B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required

6+ years of industry experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries

3+ years of people leadership experience

Prior experience in regulated, GMP manufacturing operations

Strong communication and problem-solving skills

Masters or PhD in Chemical Engineering, Biochemistry or Biology is preferred

2 to 4 years of leadership experience preferred

Experience in Cell therapy manufacturing preferred