Production Planner

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 Production Planner is responsible for coordinating and scheduling production activities across two production sites producing clinical and commercial drug products.  This role involves analyzing production specifications, capacity and resources to develop production schedules that meet customer demands and optimize production efficiency.  Work Week Schedule: •  Thursday through Monday (5 days per week / 8 hour days) or •  Friday through Monday (4 days per week / 10 hour days) 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.

Work Conditions

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.

Key Responsibilities

Assign customer orders to production slots on the manufacturing shop floor

Assign and ensure availability of materials, equipment and labor to customer orders

Utilize ERP / MES to generate manufacturing work orders

Coordinate with various teams to ensure timely manufacturing job execution and troubleshoot issues or changes to jobs

Coordinate schedule readiness and planning review meetings in review of manufacturing schedules, facility shutdowns, equipment maintenance needs and other impactful events

Tracks delivery metrics to achieve targets and customer delivery metrics

Performs capacity planning for manufacturing facilities and identifies risks, impacts and needs

Supports, as needed, Logistics management for delivery of starting material from donors and drug product materials to customers 

Qualifications

A.S. degree required; Bachelor’s degree preferred

3+ years of experience in planning and scheduling required, ideally in a biopharma manufacturing environment

Prior experience with MES and ERP systems

Personal Qualities & Physical Demands

Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize   

Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment 

Strong interpersonal skills and ability to communicate effectively

Strong problem-solving and critical thinking skills to support making decisions affecting due dates, quality and cost

Ability to gown and work in clean room areas from time to time

Ability to work in a collaborative manner, independently and as part of a team

Ability to work in a fast-paced start-up environment while following SOPs

Highly tolerant and respectful of all team members

A sense of humor is always appreciated

Strong problem-solving skills with desire to improve upon established processes

Ability to work for long periods of time at a computer

Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking