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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 is a leading innovator in the field of isotope and drug product manufacturing, dedicated to enhancing patient care through advanced therapeutic solutions. We are committed to excellence in our operations and are looking for a passionate and experienced Manufacturing, Science and Technology Specialist to join our team.
The MS&T Specialist will assist in all technical aspects of isotope and drug product manufacturing. This role will contribute to the alignment among facilities, execute technical transfers to new manufacturing sites, train manufacturing teams, and implement new processes developed by R&D. The ideal candidate will possess a strong background in pharmaceutical manufacturing engineering and cross-functional collaboration.
Primary Responsibilities
- Proactively works cross-functionally with teams such as R&D, quality, and safety to onboard new equipment and processes for manufacturing of radiopharmaceuticals.
- Ensures strict adherence to quality, safety, regulatory guidance, and written procedures in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines, FDA, OSHA, and MN DHS.
- Writes documentation such as, but not limited to user requirement specifications, system classifications, risk assessments, IQ/OQ/PQs, operational SOPs, batch records, training OJT/OJQs, logbooks, etc.
- Develops and delivers phase appropriate product understanding and control strategies.
- Working with Supply Chain individuals, orders consumables and spare parts needed for equipment and processes.
- Assists with engineering/maintenance support.
- Supports manufacturing of radiopharmaceuticals throughout the product lifecycle.
- Demonstrates willingness to be flexible and adaptable to the needs of the department and business.
- Ensures internal/external sponsor expectations are met or exceeded.
- Works with Quality Assurance on investigations, deviations, root cause analysis, out of specifications, and/or non-compliance reports.
- Ability to tech transfer equipment/processes to future facilities.
- Drives optimization of production efficiencies and capabilities by creating material workflows, room layouts, while also developing continuous process improvements.
- Performs other job-related duties as assigned.
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.
- Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related field; advanced degree preferred.
- Minimum of 4-6 years of experience in pharmaceutical manufacturing, with a focus on isotope and drug product production.
- Proven track record in technical operations, including experience with technical transfers and process implementation.
- Ability to work hands-on with production process equipment and related systems.
- Strong understanding of regulatory compliance in the pharmaceutical industry.
- Excellent communication and interpersonal skills, with the ability to lead cross-functional teams.
- Demonstrated problem-solving abilities and a data-driven approach to decision-making.
- Willingness to travel globally as required
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