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Senior Manager, External Manufacturing (CDMO Operations)

About ITM

ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).

In the United States, ITM is expanding to support our growing portfolio and pipeline. We are building a high-performing commercial team to bring innovative radiopharmaceutical therapies to patients and strengthen our presence in oncology.

You will serve as ITM USA’s on-site technical manufacturing representative at an external CDMO partner in the United States, providing oversight of aseptic radiopharmaceutical manufacturing activities and ensuring reliable GMP production performance.

This role combines external manufacturing governance, technical coordination, and hands-on operational support to support successful process transfer, qualification, and ongoing production.

During the initial phase of the role, you will be embedded on site at a partner facility in Indianapolis for a significant portion of time, providing direct oversight of production activities and serving as the primary liaison between the CDMO manufacturing team and ITM’s cross-functional subject matter experts.

This is a permanent position. Following the initial assignment in Indianapolis, the role will continue to support ITM’s broader external manufacturing network and additional CDMO partnerships. Regular travel to CDMO sites and partner facilities will be required as part of ongoing manufacturing oversight and operational support.

Senior Manager, External Manufacturing (CDMO Operations)

Your role

CDMO Manufacturing Oversight

Serve as ITM’s on-site manufacturing representative (“Person-in-Plant”) and subject matter expert at the CDMO facility during critical production runs (e.g., process qualification, initial production campaigns) and subsequent commercial manufacturing.
Act as the primary interface between CDMO manufacturing teams and ITM’s cross-functional subject matter experts.
Provide technical oversight and expertise in aseptic radiopharmaceutical manufacturing to support GMP compliance and operational reliability.

Manufacturing Readiness & Execution

Support technology transfer, process qualification, and early commercial manufacturing activities.
Monitor production execution and address operational issues impacting supply, quality, or manufacturing schedules.
Ensure alignment between ITM and CDMO teams regarding manufacturing performance, priorities, and production readiness.

Technical Operations & Process Improvement

Work with ITM subject matter experts and CDMO personnel to support implementation of process improvements and optimization of manufacturing performance.
Support operator training related to aseptic manufacturing processes.
Identify and address opportunities to improve operational efficiency, reliability, and manufacturing robustness.

Deviation Management & GMP Documentation

Support investigation and documentation of manufacturing deviations.
Review key GMP documentation including manufacturing instructions, batch records, validation protocols, and transfer documentation.
Escalate critical production, quality, or product release issues to ITM teams as appropriate.

Production Planning & Coordination

Support coordination of batch planning and production scheduling.
Provide visibility to ITM teams regarding production execution, operational risks, and manufacturing status.
Work cross-functionally with QA, R&D, Supply Chain, Regulatory, and Project Management teams.

Your profile

Master’s degree or PhD in Pharmacy, Chemistry, Biology, Engineering, or a related life sciences discipline (or equivalent industry experience).
Minimum 5 years of experience in sterile or aseptic pharmaceutical manufacturing, including roles in production, MSAT, technical operations, or process transfer.
Strong experience operating in GMP manufacturing environments, including batch record review, deviation management, and manufacturing investigations.
Experience supporting technology transfer, process qualification, or early commercial manufacturing in a GMP aseptic production environment is strongly preferred.
Experience working with external manufacturing organizations (CDMOs) or cross-site manufacturing collaboration is highly desirable.
Broad understanding of CMC, clinical manufacturing, regulatory, quality assurance, and quality control requirements across pharmaceutical development and commercial production.
Proven ability to operate in fast-paced, dynamic environments with strong prioritization and problem-solving skills.
Excellent communication, stakeholder management, and problem-solving abilities.

Our offer

Competitive base salary.
Comprehensive health benefits, including a medical plan with no employee premium and 100% company-paid dental and vision coverage.
Annual bonus opportunity.
401(k) with company match.
Generous paid time off and company holidays.
An entrepreneurial environment with the opportunity to shape a high-growth U.S. business.

Salary Range (US) $150,000 - $200,000

The compensation range for this US role is listed above for a full-time employee. Actual salary will vary based on factors such as candidate's qualifications, skills, competencies, and demonstrated experience.

ITM is an equal opportunity employer. Qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, or any other characteristic protected by law.

If you are a qualified individual with a disability or a disabled veteran and are unable to apply for a position through our online application process, you may request a reasonable accommodation. To request assistance, please contact us at careersus@itm-radiopharma.com.

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More about ITM

With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!

For more information please visit: www.itm-radiopharma.com

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