Production Supervisor, HPC, Marrow

Ossium Health · Indianapolis

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About the Production Supervisor, HPC, Marrow Job

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. 

Required 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

Preferred Qualifications

• 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

Key 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

Physical Requirements:

• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals
• Required to work the majority of the shift aseptically in a controlled environment with limited breaks. This environment requires special gowning (ie. over the head, face, hands, feet and body).
• Must be able to lift, push, pull and/or carry up to 50 lbs
• Must have sufficient manual dexterity, hand/finger coordination, wrist mobility, wrist stability, and grip strength to handle, feel, grasp, manipulate, and operate objects, manual and power tools, equipment, and controls safely and accurately.
• Regularly required to sit, stand, walk, squat, balance, climb, stoop, kneel, crouch and reach with arms.

A pre-employment physical examination is required for this position. This examination will be conducted after a conditional offer of employment has been extended and will evaluate the candidate's ability to safely perform the essential functions listed above.

Schedule:

• Full-time (40 hours per week) onsite in our Indianapolis facility
• This is a salary, exempt role
• Monday through Friday, 6:00 a.m. to 2:30 p.m; no nights and no rotating shifts to cover
• Occasional holiday and overtime work required: Typically about one Saturday and one holiday per year, driven by donor recovery timing; overtime based on production processing needs
• No weekend shifts today: As we scale toward commercial production, we expect to add weekend coverage; any change will come with significant notice and input from the operators on the floor
• Room to grow. Supervisors have the ability to advance as they qualify and gain experience, with pay increases tied to milestones

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

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