Clinical Production Operator I, HPC Marrow

About the Job

As a Clinical Production Operator, you help make HPC, Marrow, a hematopoietic progenitor cell product recovered from the vertebral bodies of deceased organ donors. You will work inside an ISO 7 cleanroom, executing production activities according to standard operating procedures (SOPs) under cGMP, and documenting your work in real time. Every unit you handle is intended for a patient with a blood, immune, or orthopedic disease, and the batch record you sign is the proof it was made correctly. This work rewards precision and repeatability over speed or improvisation.

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, you will spend most of your shift fully gowned, over the head, face, hands, feet, and body, inside a cleanroom, with limited breaks. Both are central to the job, and we would rather you know now than in your third week.

Which Level Am I?

We are hiring at two levels, and you only need to apply once. Tell us about your experience and we will place you at the level that fits.

• • Operator I: the entry point. No degree and no prior laboratory or cleanroom experience required. You will train into gowning, aseptic technique, and the HPC, Marrow process, working as an operator and building toward verifier qualification.
  • Operator II: requires at least 2 years of aseptic manufacturing experience within the last five years. No degree is required for this role. Most of our Operator I employees reach this level at their one-year anniversary.

Required Qualifications (Both Levels)

• High school diploma or GED. No college degree. No prior laboratory experience required for Operator I.
• Excellent written and oral communication skills
• Strong organization and time management, and comfort when priorities shift as we scale toward commercial production
• High level of attention to detail in checking work and information for accuracy and quality
• Reliable and able to produce consistent, high quality work
• Great work ethic, positive attitude, and ability to work as part of a team
• Operator II only: at least 2 years of hands-on aseptic manufacturing experience

Preferred Qualifications

• Hands on aseptic manufacturing or laboratory experience working in a biological safety cabinet, pipetting, preparing reagents, and using lab equipment
• Experience working in a cleanroom environment, research laboratory, cell therapy, tissue banking, blood banking, or a closely-related industry
• A track record of staying. We are looking for people who want to build a career on this team, not a stepping stone to somewhere else

Key Responsibilities

• Perform production tasks in accordance with cGMPs as an operator or verifier in the production of HPC, Marrow within an ISO 7 cleanroom environment. Tasks include receipt of donor vertebral bodies, bone preparation and marrow recovery, aseptic processing, and completion of all documentation in real time - contemporaneously, so the batch record always reflects exactly what happened.
• Maintain cleanrooms and production suites, including routine and non-routine cleaning of biological safety cabinets, cleanroom areas, and equipment; perform environmental monitoring and support continuous equipment monitoring.
• Prepare processing reagents as needed and manage material flow to and from the cleanroom, maintaining accurate inventory in the electronic inventory system.
• Collaborate with coworkers and supervisors to troubleshoot equipment or process issues, applying strong critical thinking and communication skills.
• Participate in technology transfer and process improvement activities related to new or enhanced HPC, Marrow production processes in the manufacturing facility.
• Operator II: serve more as a verifier on production runs and act as a point of escalation for equipment and process issues. Help mentor teammates on aseptic techniques.

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 an hourly, non-exempt role that is eligible for overtime
• 8-hour shifts, Monday through Friday, 8:00 a.m. to 4:30 p.m. No nights and no rotating shifts
• Occasional holiday and overtime work required. Typically about one Saturday and one holiday per year, driven by donor recovery timing
• No weekend shifts today. As we scale toward commercial production, we expect to add weekend coverage. We plan to staff it primarily with additional operators, and the current team will likely share some weekend rotation as well. Any change will come with significant notice and input from the operators on the floor.
• Room to grow. Operators advance from I to II as they qualify and gain experience, with pay increases tied to milestones. Beyond II the path continues into Operator III, Senior Operator, trainer, and other roles. As volume grows, the people we hire now are the ones who will be qualifying new operators and running the floor.