Orano Med is seeking a Production Lead to support the production of commercial radiopharmaceutical products at the ATLab Indianapolis site. Orano Med, a subsidiary of the Orano Group, is a fast-growing biotech company focusing on the development of targeted alpha therapy, an innovative class of pharmaceutical agents to combat cancer. Based on strong clinical results, Orano Med is preparing for commercialization by opening a new, state-of-the-art facility in Indiana, where Orano Med will manufacture therapeutic radiopharmaceuticals from its drug pipeline. Orano Med is looking for people passionate about fighting cancer to join our team!

Reporting to the Senior Production Manager - Therapeutics, the Production Supervisor will assist in developing procedures for routine commercial manufacturing of Orano Med products. The Production Supervisor is responsible for managing production associates/activities, timely reporting of production deliverables, and timely implementation of the production schedule.

Primary Responsibilities

• Managing production associates, including escalations to the Sr. Production Manager - Therapeutics
• Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
• Provide support to process experts / process owners including, SOP writing and revision, execution of qualification protocols, and batch records.
• Daily / Weekly reporting of production activities and escalation of delays on the production floor.
• Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
• Support equipment qualifications and improvement projects.
• Support the execution of process validations.
• Provide guidance, support, training, and knowledge to Production team.

Expanded Responsibilities:

• Take a leadership role in production team deliverables and projects
• Work with other employees on the Production and Quality teams.
• Work with Quality Unit to ensure readiness for inspections.
• Maintain compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies.
• Working as an active member of the production team on the floor, when needed.
• Review and approval of production batch documentation.
• Ensure Production teams cGMP and GDP training compliance, daily.

• 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...

Required:

• Experience
  • Hands-on GMP production of sterile pharmaceuticals: 2 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
  • Character: safety; integrity; honesty; respect authority; obey rules/policies
  • 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 skills

• Physical
  • Stand for 6 h
  • Lift/move 50 lbs repeatedly/routinely
  • Wear cleanroom PPE

Preferred:

• Experience
  
  • Safety: occupational, laboratory, chemical, radiation
  • Production of radiopharmaceuticals
  • Automation: chromatography, dispensing
  • IT/IS: eBR, eQMS, EMS, etc.
  • Disposal of chemical/RAM waste
  • Shipping RAM
  • Culture: Quality, Team, Service, Problem Solving
  • Teachable, accepts feedback; take responsibility with few excuses
  • Eager to learn new processes, accept projects, help with tasks
  • Identify problems, take initiative to solve them; push through challenges, ask for help

Orano Med encourages applicants with military experience.