Coordinate and schedule production across two manufacturing sites using ERP/MES; assign orders, materials, equipment, and labor; perform capacity planning, track delivery metrics, support logistics, and coordinate planning reviews and maintenance impacts to meet customer delivery targets.
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.
Physical Demands
- Production Associates: 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.
- 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
- Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
- Must be comfortable regularly participating in video-based meetings.
- 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
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Top Skills
Mes,Erp
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