Production Supervisor, HPC, Marrow

About Ossium

Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.

Fixed DAY shift: Monday-Friday, 6:00 a.m.

-2:30 p.m. with a 30 minute lunch break. No nights, no rotating shifts.

Onsite: Indianapolis Facility

BS or BA in a science field preferred
; high school diploma required

This position provides oversight of daily operations and training within Ossium Health’s Production group relating to the processing of donor tissue and HPC, Marrow. The Supervisor will oversee first shift staff involved in the intake, processing, and storage of donor tissue and bone marrow products for pre-clinical and clinical use. The Supervisor will ensure a safe, controlled work environment in all areas of responsibility, be aware of the site safety objectives and quality standards, and make sure they are communicated and understood by all staff.

This position will report directly to the Manager of Clinical Production.

Two things are worth knowing before you apply
. First, the source material is human. Marrow is recovered from donated vertebral bodies, and every donation reflects a decision made by a family and is a gift we fully honor. Second, processing a donor requires you to be fully gowned, over the head, face, hands, feet, and body, inside a cleanroom, with limited breaks.

• High school diploma required
• 2+ years of experience managing people
• 4+ years of experience in manufacturing
• Knowledgeable with respect to manufacturing operations in a regulated environment
• Scientific aptitude and the ability to clearly and thoroughly document all work on existing forms and records
• High level of attention to detail in both operations and documentation
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment

• BS or BA in biological sciences or equivalent
• Knowledgeable with respect to aseptic techniques, clean room environment, cellular and tissue processing
• 2+ years aseptic processing or management experience

• Oversees daily production of HPC, Marrow, including scheduling of staff and troubleshooting processing issues
• Leads daily 1st shift huddles, escalating issues related to safety, quality, delivery, cost, and people during Tier 2 huddle
• Regularly meets with direct reports and escalates any issues or concerns;
• Performs or verifies tasks in the production of HPC, Marrow as assigned
• Ensure necessary training is completed by all production staff
• Provide ongoing coaching and recognition of direct staff
• Review timesheets of direct reports
• Review bone marrow production batch records and associated documentation
• Perform allocation and authorization review for incoming donors and sample requests
• Ensures production activities are performed in accordance with current Good Tissue Practices, AATB standards, and other relevant regulations
• Author or assist in drafting and revising of departmental procedures
• Oversee the cryopreservation and initial inventory of HPC, Marrow product and samples in freezers
• Process quality monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements, and communication with production specialists regarding the monitoring of processing and product trends
• Maintain the production areas and records…