Production Supervisor – Cleanroom Biotech (HPC/Marrow)

Ossium Health; Indianapolis (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

PTO + holidays

Life insurance and long term disable

Job summary

Ossium Health is seeking a Production Supervisor, HPC, Marrow in Indianapolis to oversee daily HPC/Marrow production, staff scheduling, and early-shift operations. You will ensure GMP and safety standards, training, and documentation are maintained, reporting to the Manager of Clinical Production.

The role requires strong leadership, manufacturing experience, and a focus on quality and compliance in a cleanroom environment.

Qualifications

• 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

Responsibilities

• Oversees daily production of HPC, Marrow, including scheduling of staff and troubleshooting processing issues
• Leads daily 1st shift huddles, escalates 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

Skills

People management

Manufacturing operations

Documentation

Communication skills

Attention to detail

Time management

Education

High school diploma required

BS or BA in biological sciences or equivalent

Tools

Aseptic techniques

Clean room environment

Bone marrow processing knowledge

Job description

Ossium Health is seeking a Production Supervisor, HPC, Marrow in Indianapolis to oversee daily HPC/Marrow production, staff scheduling, and early-shift operations. You will ensure GMP and safety standards, training, and documentation are maintained, reporting to the Manager of Clinical Production.

The role requires strong leadership, manufacturing experience, and a focus on quality and compliance in a cleanroom environment.