GMP Production Associate

  • Regular/Permanent
  • USA / Texas
  • Telework not possible

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 Description:

Orano Med is searching for an energetic and highly motivated professional to participate in manufacturing of current Good Manufacturing Practices (cGMP) clinical products as GMP Production Associate.

This position will perform functions related to production and GMP manufacturing operations, including preparation of clinical doses. This position requires great attention to detail, ability to work in a team environment and interest in optimization of processes.

The GMP Production Associate will be responsible for adhering to Standard Operating Procedures (SOPs), cGMPs, and all safety requirements involving use of radioactive materials.

Major Duties and Responsibilities:

  • Perform radioactive isotope elution and chelation as part of GMP manufacturing according to
    written procedures.
  • Maintain batch records, equipment logs, and other production records as directed per company
    procedures.
  • Work concurrently with Quality Assurance personnel to deliver a quality product.
  • Follow and adhere to production schedules and timelines.
  • Execute room and equipment preparation for manufacturing operations.
  • Maintain stock of manufacturing raw materials and obtain necessary documentation.
  • Identify and communicate process failures during manufacturing.
  • Identify common equipment/process failures and troubleshoot solutions for operational
    challenges.
  • Assist in deviation investigations, corrective actions, and preventive actions.
  • Clean, sanitize and sterilize equipment and components to support production operations.
  • Perform room sanitization activities as needed to maintain controlled environment conditions.

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 should meet the following minimum requirements in order to be considered for this opportunity:

  • Ability to perform duties using proper aseptic technique
  • Bachelor of Science degree or equivalent work experience
  • Excellent documentation skills and attention to detail
  • Excellent communication, problem-solving and organizational skills
  • Ability to follow written and verbal instruction and work under supervision
  • Computer literacy and experience with Microsoft Office
  • Ability to understand and exercise basic mathematical calculations
  • Ability and interest working in a very fast-paced, high-growth team environment
  • Previous experience with electronic batch records and quality management systems a plus 

Physical requirements:

  • Ability to lift and move up to 50lbs
  • Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and
    appropriate shoes
  • Ability to gown and gain entry to controlled manufacturing areas
  • Must be able to stand, crouch, sit, bend, or stretch for extended periods of time

GMP Production Associate

Ref: 2024-15794

Regular/Permanent

Plano

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
By clicking “I accept Cookies”, you agree with the cookies use to enhance site navigation, analyze site usage and compile statistics. To get more information, please read our Cookies Policy in the Legal Notice