Position Summary:
Orano Med is seeking a Manager, Facilities for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for safety, quality, volume, speed, and reliable supply.

Job Duties:

Project Stage
Priority: Facility buildout complete

• Project
  • On-site supervisor for completion of facility: cleanrooms/labs, office renovation, hot cells
  • Support the installation/qualification of mechanical/HVAC, electrical, plumbing, cleanrooms, hot cells, fume hoods/isolators, control systems, BMS, fire safety, etc.
  • Heavy emphasis on HVAC/cleanrooms/BMS
• Liaison with service providers
  • Primary point of contact; supervise on-site work
  • Obtain competitive quotes, select vendors, negotiate pricing, approve POs/vendor bills, cultivate relationships
  • Manage contracts (e.g., pest control, fire monitoring/suppression, landscaping/snow, equipment PM/repair, custodial services)
• Assist with
  • Safety programs: radiation, laboratory, occupational
  • Facility licensing/compliance: RAM, effluents/emissions, sewer water/storm water, building codes (fire/electrical)
  • Cleanrooms: Participate in cleaning, IQ/OQ/PQ
  • Establish a system for scheduling/recording: warranties, inspections, PMs, repairs

Production Stage
Priority: Facility ready to produce GMP doses

• Continue tasks above, as needed
• On-call to react to alarms/emergencies/urgent facilities problems that might cause production delays
• Production area: Ensure safety and readiness
• Inspections/PM/repairs of facilities-related equipment: In-house or supervise contractors (e.g., emergency showers/eyewash, fire sprinklers/extinguishers, emergency alarms/systems, backup power transfer)
• Facilities equipment: Manage warranties, service contracts; schedule PMs, requalification
• Documents for facility: Draft/review SOPs, IQ/OQ/PQ, other protocols/reports
• Maintain a stock of spare parts/other supplies
• Assist with budget forecasting of CapEx/OpEx
• Waste management: RAM, chemical, garbage, recycling
• Assist with investigations for Quality Unit (deviations/OOS/recalls/FMEAs)
• Facility renovations/expansions: planning, bidding, selection/contracting, design, project management

All Stages

• Frequent facility inspections inside/outside[HE(C5]
• Expert on the facility for inspectors/management/staff
• Review/approve documents: quotes/contracts, PMs, final reports, invoices
• Manage badge access system
• Attributes
  o Character to exemplify: integrity, team spirit, service attitude, initiative, problem solving, attention to detail
  • Embody a culture of safety, quality, continuous improvement, customer service
  • Press toward ambitious goals/timelines; motivate colleagues
  • Comply with SOPs, policies, regulations, laws
  • Represent employer well at all times
• Location: On-site 100%; Travel <10%
• Other tasks/responsibilities as needed

Our Full-Time Benefits

• Competitive compensation
• Health, Dental, and Vision insurance – with generous employer contributions
• 401(k) with employer matching and contribution amounts

• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities

• and more…

Orano Med encourages applicants with military experience for this position.

Required:
Attributes

• Work with urgency to fix problems quickly for production at GMP standards
• Attention to detail; meticulous GDP documentation
• Physical: Safely lift 50 lbs.

Experience/Education

• Safety practices: construction site safety; occupational health/safety
• Facilities: 5 yr. in any industry, incl. 2 yr. pharmaceuticals
• Cleanrooms: 2 yr.
• GMP: 1 yr.
• Equipment: Installation, IQ/OQ/PQ, calibration, PM, systematic troubleshooting, basic repairs

Preferred:
Attributes

• Problem solving: Identify, take initiative, overcome obstacles, solve the problem
• Adaptable: Work well leading a group or working independently
• Seize opportunities to work on a project or help with a task
• Verbal/written communication: concise, clear, efficient
• Service attitude toward colleagues
• Cross-functional teamwork/leadership
• Professionalism; organized work style/space
• Teachable: Open to constructive feedback.

Experience/Education

• Safety: laboratory, radiation
• Radioactivity: 2 y
• Aseptic manufacturing: 2 y
• Radiopharmaceuticals
• Software systems: QMS, BMS, EMS
• Technical writing (SOPs, protocols, reports)
• Commissioning new facilities

Education:

Associate’s or Bachelor’s degree in a scientific/technical field