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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 seeking a Manager, Logistics or Senior Manager, Logistics for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.
The Sr. Manager, Logistics will oversee the supply chain and ensure conformity of all RAM shipments to/from the ATLab facility, with emphasis on overnight product shipments. This position presents the opportunity to establish a new facility that will meet high expectations for quantity, speed, and reliability of supply. This position is hands-on for performing shipping tasks.
Prior to on-site operations:
- Work with Production/Quality to define workflow, shipping equipment, criteria, responsibilities
- Meet DOT/IATA regulations for safe shipment of RAM (containers used, pre-shipment checks, paperwork)
- Support SOPs, including delivery of RAM to ATLab IND and disposal of RAM waste
- Work with external vendors to identify best routes for clinical sites with potential backup solutions; negotiate contracts
- Processes for return of containers
- Build reporting tools to monitor shipments and KPIs
- Planning/coordination/troubleshooting for logistics to/from all US Orano Med facilities
Once production begins:
- Top priority: overnight shipping of doses
- Support efforts for seamless operations: tracking systems, isotope supply chain, processes
- Troubleshoot urgent problems with incoming/outgoing shipments
- Lead efforts for shipping automation
- Investigation/mitigation of relevant events (deviations, OOS, recalls, complaints)
- Embody quality, continuous improvement:
o Adhere to SOPs, company policies, regulatory requirements, and laws
o Monitor KPIs; communicate to management; make improvements
o Change controls, SOP revisions; strategies for implementation
o Support increasing requirements during ramp-up
Relocation to Indianapolis region by 2023-Q3, then 100% on-site, with <20% travel.
Other responsibilities as needed. Level of position offered will depend on candidate's years of experience.
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
Required
- Experience
- Relevant work: 3+ yrs
- Radiopharmaceutical shipping: 1+ yrs
- Strong knowledge of DOT, IATA regulations
- Radiation safety: handling/disposing of RAM; checking dose rates/contamination; ALARA practices
- Personality
- Character: radical integrity; honesty; obeys rules / policies / regulations / laws
- Work effectively on simultaneous tasks in a high-pressure environment with tight deadlines
- Detail-oriented; organizational skills; time management; meticulous execution and documentation
- Physical: Stand for 6+ hours; Lift/move 50 lbs
Preferred
- Experience
- Shipping radioactivity (any form): 3+ yrs
- Pharmaceutical manufacturing (any job function): 2+ yrs
- Shipping 10+ packages per day
- DOT 7A Type A Containers: Selecting, performing container tests
- Familiarity
- Safety practices: occupational, laboratory, chemical, radiation
- Comfortable with quality systems: QMS, QA, GDP, SOPs, change control, document control, detailed documentation
- Experience in establishing procedures, KPIs, and monitoring them
- Proficient in Word and Excel software
- FedEx: shipping software (e.g., FedEx Ship Manager); personal connections; general familiarity
- Culture/Personality
- Team-minded; ability to work with cross-functional teams
- Communication: Concise, organized oral/written communication; excellent listening
o Able to thrive and work collaboratively in a fast-paced team environment
o Successful in various situations: independent tasks, following instructions, leading a team
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