Production Supervisor, HPC, Marrow

Ossium Health•Indianapolis, IN

48d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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 in an inspection ready state at all times
Work with Sterile Processing team and Equipment team to monitor production equipment/tools and ensure all is kept clean, in working order, and within calibration/PM schedule
Interact with QA department to complete event reports, deviations, CAPAs, and change controls
Interact with QC department to submit sample requests and prepare reports
Interact with Management to provide updates, results, suggestions, and work area/process observations