Operations Manager, HPC

The role

The Operations Manager, HPC leads the hematopoietic progenitor cell production team. You will own the HPC value stream at the Indianapolis facility and lead the cross-functional Core Team.

What you will do

• Own daily HPC production output from donor intake through cryopreservation
• Manage HPC Production Supervisors across shifts
• Serve as operator, verifier, or trainer during clinical production as needed
• Develop and report production metrics
• Perform technical review of production batch records
• Write and oversee event reports, investigations, risk assessments, and CAPAs
• Lead operational changes through project management and document creation
• Serve as hiring manager for HPC production roles
• Serve as Core Team Leader for HPC, Marrow
• Partner with Tissue Production, MSAT, Engineering, Quality, Supply Chain, and Facilities

Required qualifications

• BS/BA in a technical field or equivalent experience
• 5+ years of manufacturing or related experience
• 3+ years in a formal people-leadership role
• Working knowledge of aseptic technique, cleanroom operations, and cGTP/cGMP requirements
• Experience owning deviations, investigations, and CAPAs, including root cause analysis
• Excellent written and oral communication skills
• High level of attention to detail
• 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
• 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

Nice to have

• Advanced degree in a relevant scientific discipline
• Direct experience managing teams in an aseptic manufacturing environment
• Trained in statistical process control and continuous improvement tools and methodologies
• Experience supporting FDA or other regulatory and accreditation inspections
• Experience with process validation and technology transfer from development into routine production
• Familiarity with lean or tiered daily management practices

Benefits

• 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
• Employer paid long term disability
• Gym membership/recreational sports reimbursements

Before you apply

• Principals / direct applicants only please

About the company

Ossium develops, manufactures, and banks cell therapy products to improve human health, vitality, and longevity through bioengineering.