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Manufacturing Manager - Yokohama

Manufacturing Manager - Yokohama

TelixJP
30+日前
職務内容の詳細

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation.  At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.  You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

The Manufacturing Manager is responsible for overseeing the end-to-end production of radiopharmaceuticals, ensuring compliance with Good Manufacturing Practices (GMP), radiation safety regulations, and company quality standards. This role involves managing production schedules, optimizing manufacturing processes, ensuring regulatory compliance, and leading a team to maintain efficient and safe operations.

Key Accountabilities :

  • Manufacturing Operations & Compliance

Oversee daily production activities, ensuring compliance with GMP, PMDA (Pharmaceuticals and Medical Devices Agency) regulations, and radiation safety guidelines.

  • Develop and optimize manufacturing processes for efficiency, quality, and safety.
  • Ensure proper aseptic techniques and cleanroom procedures are followed in production.
  • Manage batch record review, deviations, CAPA (Corrective and Preventive Actions), and continuous improvement initiatives.
  • Coordinate with Quality Assurance (QA) and Quality Control (QC) to ensure timely product release.
  • Team Leadership & Training

    • Lead and develop the manufacturing team, ensuring proper training in GMP, radiation safety, and operational procedures.

  • Foster a culture of safety, compliance, and continuous improvement.
  • Conduct performance evaluations and provide coaching for staff development.
  • Regulatory & Documentation Management

    • Ensure compliance with local and international regulations (PMDA, ICH, PIC / S).

  • Support regulatory inspections, audits, and licensing activities.
  • Maintain accurate and timely documentation, including SOPs, batch records, and deviation reports.
  • Process Improvement & Technology Integration

    • Identify opportunities to improve manufacturing efficiency and reduce waste while maintaining product quality.

  • Implement automation and digitalization initiatives where applicable.
  • Collaborate with R&D and engineering teams for process optimization and new product introduction.

    • Education and Experience :

  • Bachelor's or Master’s degree in Pharmacy, Chemistry, Biotechnology, Engineering, or a related field.
  • 5+ years of experience in pharmaceutical or radiopharmaceutical manufacturing in a GMP-regulated environment.
  • Strong knowledge of aseptic processing, cleanroom operations, and radiation safety.
  • Experience with regulatory inspections and audits.
  • Proven leadership, problem-solving, and decision-making skills.
  • Business-level proficiency in Japanese; English proficiency is a plus.

    • Preferred Certifications

  • GMP certification or training in aseptic processing.
  • Radiation safety certification (if applicable).
  • Lean Manufacturing or Six Sigma certification is a plus

    • Key Capabilities :

  • Strong communication skills, effective across all levels of the organization.
  • working with regulatory authorities across the Asia-Pacific region.
  • Proficient understanding of both early and late-stage drug development processes, including clinical and non-clinical requirements, at an advanced level.
  • Strong ability to collaborate effectively with teams across the region.
  • Demonstrate a dedication to continuous learning and professional growth, actively pursuing opportunities to enhance your expertise and skill set.
  • Uphold integrity and exhibit a steadfast commitment to ethical conduct in all dealings with colleagues and stakeholders.

    • At Telix, we believe everyone counts , we strive to be extraordinary , and we pursue our goals with determination and integrity . You will be part of an engaged and supportive group of colleagues who all have a shared purpose : to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

    Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

    VIEW OUR PRIVACY POLICY HERE

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