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Welcome to Orano Med
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.
With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Job description
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…
Ideal qualifications
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
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Find out more about Orano Med
Find out more about Orano Med