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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.
- 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
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.