Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.

The top priority for the Senior Production Operator will be routine production. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability. A competitive candidate will be energetic and motivated.

Key Responsibilities

• Work with Production Supervisor, Management and MS&T team to improve the process
• Collaborate with the shift supervisor to ensure the shift is running efficiently while leading by example
• Collaborate with the shift supervisor to train and mentor other members of the team
• Writing/Reviewing/Executing relevant SOPs, Qualifications, and internal studies
• Implement new equipment, materials, software, systems
• Environmental qualifications of new cleanrooms
• Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transfer
• Top priority: Daily routine production 
• Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc.
• Manufacturing activities following SOPs, using proper aseptic technique
• Setup production; line clearance; clean/VPHP
• Troubleshoot urgent problems
• Mentor and cross-train new employees
• Identify, document, communicate failure/near misses

Quality/continuous improvement

• Adhere to SOPs, company policies, regulatory requirements, laws
• Work closely with QC/QA to deliver quality products
• Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections
• Cleanrooms: cleaning, EM, restocking
• Packaging/labelling/driving/shipping of radioactive product
• Routine radiation surveys, wipe tests
• Maintain paper/electronic batch records, equipment logs, other records
• Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting
• Maintain stock of materials/supplies; obtain documentation for raw material release

Qualifications

Education

• Associate’s degree or equivalent (60 college credit hours) with 5+ years of relevant experience, or
• High School Diploma (or equivalent) with 7 or more years of experience in a quality or production-related role within a GMP environment.

Experience

• Hands-on GMP production of sterile pharmaceuticals: 5+ yrs
• Cleanroom operations: gowning, cleaning, EM, aseptic technique
• Follow detailed SOPs, complete detailed documentation (e.g., batch records), patiently revise per QA
• QMS in a regulated environment: QA, GDP, SOPs, document control, change control
• Safety: occupational, laboratory, chemical, radiation
• Production of radiopharmaceuticals
• Automation: chromatography, dispensing
• IT/IS: eBR, eQMS, EMS, etc.
• Disposal of chemical/RAM waste
• Owns the manufacturing process; work well in a fast-paced, high-pressure environment with tight deadlines
• Attention to detail; meticulous execution/documentation
• Attendance: dependable, on time; flexible for variable schedule
• Work well under direct supervision or independently
• Time management
• Stand for 6+ hours
• Lift/move 50 lbs repeatedly/routinely
• Wear cleanroom PPE
• Strong attention to detail and organizational skills.
• Proficiency in document management systems and Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.