GMP Manufacturing Technician

DescriptionDescriptionOrano Med TheranosticsOrano 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.We are seeking a highly motivated GMP Manufacturing Technician who will be responsible for non-clinical GMP manufacturing, maintaining the GMP suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Manufacturing Technician assists with clinical material manufacturing as well as preparation for clinical product manufacturing. This position conducts routine maintenance of areas and equipment and maintains accurate records of operations within GMP suite.Key ResponsibilitiesFollow written procedures for non-clinical manufacturingComplete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelinesWork concurrently with Quality Assurance (QA) and Quality Control (QC) personnel to deliver a high-quality productFollow and adhere to production schedules and timelinesExecute room and equipment preparation for manufacturing operationsPerform room sanitization activities as needed to maintain controlled environment conditionsParticipate in isolator and room monitoringParticipate in room and isolator preparation for manufacturingStocking materials in the GMP labs Identify and communicate process and equipment failures during manufacturing to supervisor and equipment team Identify process errors and report to supervisorParticipate in deviation investigations and follow management guidance for corrective and preventive actionsClean, sanitize and sterilize equipment and components to support production operationsInitiate cleaning procedures for the labs, perform routine maintenance on equipment, restock labsDemonstrate ability to perform tasks with minimal guidance once trainedComplete training on Master Batch Records, Formulation Records, and Protocols related to non-clinical manufacturingComplete on the job training for cleaning, gowning, GMP suite access, and equipmentOrano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.This position requires a pre-employment background check and drug screening.Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status.RequirementsAll candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.Minimum QualificationsAssociate degree in a related field or comparable work experience0 -1+ year's experienceChemistry or Microbiology lab experience, knowledge of chemical safety and lab hygieneRequired Skills & CompetenciesChemistry or Microbiology lab experience, knowledge of chemical safety and lab hygieneAbility to work side by side with the quality assurance departmentExcellent documentation skills and attention to detailExcellent communication, problem-solving and organizational skillsAbility to follow written and verbal instruction and work under supervisionComputer literacy and proficiency with Microsoft OfficeAbility to understand and exercise basic mathematical calculations and more complex calculations with various available tools and calculatorsAbility to work in a very fast-paced, high-growth team environmentAbility to perform duties using proper aseptic techniquePreferred Skills & Competencies* Communications Skills, Ability to Learn, Initiative, Dependability, Productivity, Quality of Work, Safety, Teamwork