About the Job

We’re hiring an Equipment Technician who will focus on critical equipment to ensure that our clinical production team has everything they need to process and bank life-saving bone marrow.  In this role, you’ll be responsible for a variety of facility and equipment cleaning, maintenance, installation, operation, and troubleshooting to keep operations running smoothly in our cGMP (current Good Manufacturing Practice) facility.  This is a hands-on role, and we’ll train you on Good Documentation Practices, preparing tools for sterilization, and other support tasks which are key for a biotech manufacturing facility. Restocking materials and reagents as well as cleaning equipment/tools and autoclaving may also be a part of your daily routine.

This role reports to the Facilities Manager, and will work closely with both the Facilities team and the Clinical Production team.

Required Qualifications

• High School Diploma
• Ability to solve technical and performance problems using information from a variety of sources
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This is an hourly, non-exempt role based in our Indianapolis facility
• We are currently hiring for Monday through Friday 8am - 5pm

Preferred Qualifications

• Experience working hands-on with laboratory/clinical equipment

Key Responsibilities

• Perform scheduled maintenance inspections and assurance inspections on equipment to ensure safe and effective operating conditions
• Assist with qualification of new equipment
• Test and calibrate components using a variety of manuals, troubleshooting techniques, and code requirements
• Perform routine preventative maintenance and calibrations of equipment
• Assist with cleaning, calibration, and maintenance of quality control, production, and research lab equipment, including non-routine maintenance and scheduling service or calibration with outside vendors as needed
• Assist in repair and replacement of complex medical equipment and systems
• Install and test a variety of medical and research equipment
• Diagnose equipment malfunctions with accuracy
• Perform activities in accordance with current GDP and cGMP 
• Recognize and communicate production and work environment issues/observations to supervisory staff in a timely manner

In your first six months some projects you’ll work on include:

• Training on gowning and cleaning practices for the cleanroom support areas
• Shadowing Clinical Production personnel and observe processing 
• Assisting Clinical Production team in developing improved tool cleaning procedures
• Learning the basics of safety, sterility, and the general flow of our methods and operations
• Understanding our freezers (-80° & -190°) and how they operate, fill and alarm
• Gaining familiarity with switching out Co2 and LN2 tanks

Physical Requirements

• Requires training in blood borne pathogen safety measures; new hires will be given the option of Hepatitis B vaccination
• Requires standing, walking, pushing, kneeling, twisting and reaching
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals 
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time
• Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms

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

About the Job

This is a high-impact leadership role responsible for end-to-end supply chain and logistics operations supporting our manufacturing site and patient-facing fulfillment. As the Director of Supply Chain and Logistics, you will lead material planning, procurement, inventory management, cold chain logistics, and order fulfillment to ensure reliable, compliant, and efficient product delivery.

You will partner closely with Manufacturing, Quality, Engineering, MSAT, Sales, and Commercial teams to ensure seamless integration between supply and demand, positioning Supply Chain and Logistics teams as both an operational backbone and a strategic enabler of growth. As a key member of the Site Operations Team and leader of our Downstream Core Team, you will drive disciplined execution, visibility, and continuous improvement across the organization.

This role is ideal for a leader who thrives in complex, regulated environments, builds scalable systems, and is energized by ensuring life-saving products reach patients reliably and on time. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Supply Chain, Operations, Engineering, Business, or related field
• 10+ years of experience in supply chain, logistics, or operations in a regulated manufacturing environment (pharma, biotech, medtech preferred)
• 5+ years of people management experience leading supply chain or logistics teams
• Strong understanding of GMP/GTP requirements as they relate to materials, storage, and distribution
• Experience with inventory planning, procurement, and supplier management including ERP/MRP systems and inventory planning tools
• Proven track record of improving service levels, reducing shortages, and optimizing inventory
• Strong analytical, problem-solving, and communication skills

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing environments
• Experience with cold chain, time-sensitive distribution, and external logistics provider management
• Familiarity with S&OP/S&OE processes and cross-functional demand–supply alignment
• Experience driving supply chain optimization through automation, digital tools, or advanced analytics
• Lean or Six Sigma certification with demonstrated application in supply chain environments
• Experience supporting regulatory inspections (FDA, AATB, or equivalent)

Key Responsibilities

• Lead, mentor, and develop a high-performing supply chain and logistics teams across procurement, planning, inventory, and fulfillment
• Own end-to-end material flow from supplier through manufacturing to patient delivery
• Ensure reliable supply of materials and on-time fulfillment of finished goods to meet patient demand
• Establish and maintain inventory strategies that balance availability, risk, and working capital
• Oversee cold chain logistics, shipping, and distribution, ensuring product integrity and compliance
• Manage supplier relationships, including performance, risk, and continuity of supply
• Drive S&OE processes to align demand, supply, and execution across the site
• Identify and mitigate supply chain risks, including shortages, delays, and capacity constraints
• Partner with Manufacturing, QA, and Engineering to support production and capacity scaling
• Lead continuous improvement initiatives to increase service level, reduce cost, and improve efficiency
• Ensure compliance with GMP/GTP, internal procedures, and regulatory expectations
• Support audits and represent Supply Chain during regulatory inspections
• Develop long-term supply chain strategy aligned with commercial growth and new product launches
• Lead the site’s cross-functional Downstream Core Team, overseeing Release and Distribution processes to ensure reliable, compliant product availability
• Travel (domestic and international) when required (<10%) to support supply chain and logistics planning or projects

In your first six months some projects you’ll work on include:

• Assess current inventory levels, service levels, and supply chain risks across all products
• Strengthen supplier management and sourcing strategies for critical materials
• Optimize cold chain logistics performance, including carrier reliability and cost
• Develop a 12-24 month supply chain roadmap aligned with growth and product launches

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

About the Job

This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Senior Manager of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow.

You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site.

This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment
• 4+ years of people management experience leading engineers or technical staff
• Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
• Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
• Proven track record of improving equipment reliability and reducing unplanned downtime
• Strong project management, documentation, and communication skills
• Experience with root cause analysis, FMEA, and SOP development
• This position is based full time onsite in our Indianapolis facility

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas
• Familiarity with computerized maintenance management systems (CMMS)
• Experience leading capital projects and facility expansions
• Lean or Six Sigma certification
• Experience implementing automation and digital engineering solutions
• Experience interacting with regulatory inspectors (FDA, EMA, or equivalent)
• Expertise in business intelligence and analytics (Tableau, Power BI, SQL)

Key Responsibilities

• Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
• Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
• Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement
• Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved
• Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk
• Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
• Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures
• Lead root cause investigations related to equipment, utilities, and facility systems
• Drive data-based reliability improvements using trend analysis and KPIs
• Support inspection readiness and represent Engineering during regulatory audits
• Develop long-term facility and infrastructure strategy aligned with commercial growth plans
• Travel (domestic and international) when required (<10%) to support other sites

In your first six months some projects you’ll work on include:

• Assessing current equipment reliability, PM effectiveness, and engineering KPIs
• Implementing a new CMMS software platform
• Identifying and prioritizing capital investments to support production growth
• Standardizing engineering documentation and technical standards
• Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

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

About the Job

This position provides technical support and execution of tasks within Ossium Health’s Clinical Production group relating to preparation of human bone marrow-derived materials for pre-clinical and clinical use. Tasks require following standard operating procedures (SOPs) to process human tissue in an ISO7 cleanroom environment for Ossium’s bone marrow and tissue products. Position requires basic judgment in resolving problems, effective communication with coworkers and management, and close attention to detail.

Required Qualifications

• High school diploma
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and time management in a dynamic startup environment
• 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

Preferred Qualifications

• Hands on 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

Key Responsibilities

• Perform production tasks in accordance with GMPs as operator or verifier in the production of tissue and/or bone marrow products in an ISO7 cleanroom environment. Tasks include tissue receipt, tissue processing, and cell processing utilizing some automated equipment while completing documentation in real time
• Maintain cleanrooms and production suite, including but not limited to routine and non-routine cleaning of biological safety cabinets, cleanrooms and equipment, environmental monitoring of cleanrooms, and continuous monitoring of equipment
• Maintain cryogenic freezers and product inventory using an electronic inventory system
• Collaborate with coworkers and supervisor to effectively troubleshoot equipment and process issues using critical thinking skills
• Participate in development and tech transfer activities related to new or enhanced processes in the production facility

Physical Requirements

• Must be able to work aseptically in controlled environments requiring special gowning (ie. over the head, face, hands, feet and body)
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms.

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 schedule with two different schedules open:
  • 1st shift: 6 am start time
  • 2nd shift: 10 am start time
• Some holiday and overtime work required

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 

About the Job

We’re looking for a Quality Control Associate to provide technical support and execution of tasks within Ossium Health’s Quality Control Laboratory, relating to testing of human bone marrow-derived materials for pre-clinical and clinical use. Successful candidates have a basic understanding of the theory, concepts and regulations behind cGMP regulations and CLIA regulations. You’ll help to ensure that we maintain the highest levels of quality and safety standards on a day to day basis. This is a great opportunity for detail-oriented individuals looking to further a career in biotechnology and quality systems.

Required Qualifications

• BS or BA in biological sciences
• High level of attention to detail in both operations and documentation
• Reliable and able to produce consistent, high quality work
• Great communication skills and organization, able to work as part of a team
• Great work ethic and positive attitude
• Strong computer skills, including Microsoft Office
• Strong attention to detail and observational skills
• This position is based full time in our Indianapolis facility

Preferred Qualifications

• Experience working in a CLIA laboratory, cell therapy, tissue banking, blood banking, or other relevant industry experience
• Experience with flow cytometry, hematopoietic colony forming unit assay, and ELISA
• Exceptional laboratory technique
• Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, 42 CFR 493, AATB Standards, and other GMP requirements
• Strong knowledge of data analysis and statistical methods
• Hands-on experience in MasterControl, including the quality modules and production records

Key Responsibilities

• Perform tests as operator or verifier in the testing of bone marrow derived products 
• Maintain data and documentation related to testing of bone marrow derived products obtained internally or externally
• Update product and sample inventory using an electronic inventory system
• Assist in shipping of testing samples and product from bank
• Perform routine and advanced duties required to clean, maintain and operate testing equipment and storage equipment
• Assist in drafting and revising of departmental procedures
• Work with coworkers and supervisor to effectively troubleshoot equipment and testing issues

Physical Requirements

• Must be able to work aseptically in controlled environments requiring special gowning (i.e. over the head, face, hands, feet and body)
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms.

Schedule

• Full-time (40 hours per week)
• This is an hourly, non-exempt role that is eligible for overtime
• Our QC lab is staffed for testing Monday through Friday, including holidays. The schedule for this position is 4 x 10 hour shifts either Monday-Thursday or Tuesday-Friday

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