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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
Orano Med:
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
Job Summary:
Orano Med is seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ 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 quality, volume, speed, and reliability.
Job Responsibilities:
- Oversee IQ/OQ/PQ for new instruments
- Draft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports)
- Equipment/service logs: establish, review, maintain
URS for equipment: Assist with drafting/review/approval - Responsible for a variety of cGMP and non-cGMP instruments including:
- Production: preparatory LC, fluid transfer, dispensing, weighing, EM
- QC: LC, HPGe, gamma counter, sterility, analytical balances, pipettes
- Hot cells: VPHP, EM, fill/finish, other sensors/controls
- Safety: radiation detectors for personnel, surfaces, air
- General: refrigerators/freezers, incubators
- Assist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc.
- Work with instrument operators to develop robust protocols for system suitability checks for equipment
- Assist with vendor qualifications
- Top Priority: On-Time Production/Release of Product Batch Release
- All tasks from the Setup Phase that continue into Production Phase.
- Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status.
- Preparation of calibration certificates and data reports using appropriate Quality documentation.
- Ensuring that the equipment is calibrated as per specifications and industry standards.
- Oversee warranties, PMs, scheduled recalibration/requalification
- Scheduling appointments for equipment maintenance and servicing.
- Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasks
- Testing repaired equipment to verify qualified status
- Ensuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies.
- Expert on instrumentation: liaison to management/inspectors
- Write protocols for in-house calibrations/qualifications
- Analyze/suggest equipment upgrades and software
- Study industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.)
- Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.
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
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher level position.
Experience:
• BA/BS in a technical field (preferred)
• 2+ y instrumentation, including 1+ y in pharmaceuticals
• Cleanrooms, aseptic technique
• CQV, QMS, cGMP
• FDA regulations, compendial guidelines
• Safety awareness/practices
• Excellent technical skills, troubleshooting
• Ability to meet same-day deadlines
• Attention to detail
Orano Med LLC
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