Orca Bio

Biotechnology

Supervisor,CommercialManufacturing-DayShift

$70–100k Sacramento, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Supervisor, Commercial Manufacturing - Day Shift at Orca Bio. Skills: Cell therapy production, cGMP compliance, Team supervision. Supervise and lead associates. Coordinate daily manufacturing activities”

What You'll Achieve.

Meet schedule goals; Meet quality goals; Meet compliance goals; Increase reliability; Increase efficiency

Industry & Context.

Biotechnology
Problems you'll solve

Troubleshoot production activities

Eligibility Requirements

Visual acuity 20/20, Normal color vision, Cleanroom gowning, Work at multiple locations, Scheduled overtime, Work weekends, Work holidays, Remain stationary 50%

What They're Looking For.

Must Have

B. S. degree in biology, 2+ years supervisory experience, Understanding of aseptic manufacturing, Clean room operations knowledge

Nice to Have

M. S. degree in biology, Prior cell therapy experience, Experience with deviation investigations, CAPA experience, Change control process experience

What You'll Do.

Supervise and lead associates

Coordinate daily manufacturing activities

Execute and enforce cGMP-compliant SOPs

Provide on-the-floor training

Provide performance feedback

Monitor production activities

Troubleshoot production activities

Escalate production issues

Support in-process checks

Support deviation investigations

Support batch record reviews

Maintain real-time documentation

Support continuous improvement initiatives

Participate in CAPA investigations

Participate in deviation investigations

How You'll Work.

Team & Collaboration

Cross-functional teams

Full Job Description

## Description 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 Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.   Day Shift: • 6:00am to 6:30pm or • 6:30am to 7:00pm   Work Week Schedule: •  Sunday, Monday, Tuesday + every other Wednesday or •  Thursday, Friday, Saturday + every other Wednesday ## 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

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