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Director Cmc Radiopharmaceutical Jobs (NOW HIRING)

AstraZeneca GmbH

Associate Director, CMC Lead

Boston, MA · On-site

$136K - $204K/yr

Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC strategy ... radiopharmaceutical manufacturing capabilities and an advancing clinical pipeline. How will you ...

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Director Cmc Radiopharmaceutical information

What does a director CMC radiopharmaceutical do?

A Director of CMC (Chemistry, Manufacturing, and Controls) Radiopharmaceutical is responsible for overseeing the development, manufacturing, and regulatory strategies for radiopharmaceutical products. This role involves managing teams that handle product formulation, process development, quality control, and compliance with regulatory requirements. The director ensures that all aspects of the product lifecycle, from research through commercial manufacturing, meet industry standards and regulatory guidelines. Additionally, they collaborate with cross-functional teams to drive project timelines and support clinical and commercial supply needs.

What are the key skills and qualifications needed to thrive as a director CMC radiopharmaceutical?

To thrive as a Director CMC Radiopharmaceutical, you need expertise in chemistry, manufacturing, and controls (CMC) for radiopharmaceuticals, often supported by an advanced degree in chemistry, pharmacy, or a related field and significant industry experience. Experience with regulatory requirements (e.g., FDA, EMA), quality management systems, and familiarity with tools like LIMS and process validation software are crucial. Strong leadership, project management, and cross-functional communication skills set top candidates apart. These competencies ensure effective oversight of complex product development, regulatory compliance, and successful cross-disciplinary collaboration in a highly regulated environment.

What are some of the main challenges faced by a director CMC radiopharmaceutical in ensuring regulatory compliance across global markets?

A Director of CMC Radiopharmaceuticals often navigates complex regulatory requirements that can vary significantly between regions such as the FDA, EMA, and other global health authorities. Ensuring consistent quality, safety, and documentation standards for radiopharmaceutical products requires close collaboration with cross-functional teams in manufacturing, quality assurance, and regulatory affairs. Keeping up-to-date with evolving regulations and managing timely submissions are key challenges, as is the need to address issues that may arise during inspections or product lifecycle changes. Proactive communication and strong project management skills are essential for success in this role.

What are popular job titles related to Director Cmc Radiopharmaceutical jobs?

For Director Cmc Radiopharmaceutical jobs, the most frequently searched job titles are:

Infographic showing various Director Cmc Radiopharmaceutical job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 69% In-person, and 31% Remote job distribution.

Director, CMC - Radiopharmaceutical Process Development

Boston, MA • On-site

AdvanCell
See more jobs at AdvanCellexternal

$170K - $220K/yr

Full-time

Posted 9 days ago

Job description

Partnering closely with the Technical Development and Manufacturing Science & Technology (MSAT) teams, the Director, Radiopharmaceutical Process Development plays a central role in defining and executing phase-appropriate CMC strategies to support the development, optimization, and internal scale-up of manufacturing processes for the company's 212Pb-based APIs and radiopharmaceutical products. The role provides technical leadership across process development, process characterization, scale-up, technology transfer, and manufacturing readiness, ensuring a seamless transition from development to robust, scalable, and GMP-compliant manufacturing.

The successful candidate is responsible for leading CMC regulatory authoring and documentation to support global regulatory submissions, lifecycle management of regulatory dossiers, and responses to health authority inquiries. The role also drives continuous improvement initiatives that strengthen process understanding, manufacturing robustness, and advancement of the company's radiopharmaceutical portfolio.

Working in close collaboration with Technical Development, MSAT, Quality, Engineering, and Operations, this position provides leadership in equipment selection, facility readiness, operational start-up, and technology transfer activities to ensure successful integration of new processes into internal manufacturing operations and readiness for clinical and commercial supply.

In addition, the Director provides targeted technical support to the Director of External Manufacturing on CDMO-related activities, including technology transfer, process performance assessment, manufacturing investigations, and process optimization. The role helps ensure alignment between internal development programs and external manufacturing strategies to support a reliable, scalable, and compliant supply network.

Key Responsibilities and Duties

  • Develop phase-appropriate CMC strategies and ensure generation of the supporting data, technical documentation, and regulatory submission packages

  • Partner closely with Technical Development and MSAT to align process development, optimization, and scale-up activities for Pb based API and radiopharmaceutical manufacturing processes.

  • Drive process characterization and lifecycle development studies to establish critical process parameters, critical quality attributes, and control strategies

  • Establish phase-appropriate drug substance and drug product specifications based on process understanding, manufacturing performance data, and overall CMC strategy

  • Ensure process development activities comply with GMP requirements and applicable radiopharmaceutical regulatory standards.

  • Provide technical leadership for regulatory interactions related to process design and control strategies

  • Partner with Quality Assurance on investigations, change controls, and audit readiness activities

  • Provide targeted technical support to External Manufacturing for CDMO related activities.

  • Lead process investigation, troubleshoot manufacturing and development challenges, and drive continuous improvement initiatives

  • Mentor, coach, and develop Radiopharmaceutical Process Development staff.

Other Responsibilities

  • Observe the Company's workplace, health and safety, and regulatory policies and procedures.

  • Engage and communicate with other AdvanCell business unit staff to ensure that activities are undertaking seamlessly and effectively.

  • Adhere to the Company's quality management system processes and policies.

  • Other tasks as requested by the VP, CMC and Supply Chain

Essential Skills, Qualifications, Industry and Educational Requirements

  • Ph.D. in chemistry, engineering, pharmaceutical sciences or a relevant discipline.

  • Minimum 4 years of experience in radiopharmaceutical industry with a focus on CMC development, process development, and technical operations.

  • Advanced understanding of (radio)pharmaceutical manufacturing, process scale-up, and quality control methodologies

  • Strong understanding of GMP requirements, radiopharmaceutical regulations, and industry standards across product development and commercialization

  • Excellent communication, technical writing and analytical problem-solving skills.

  • Demonstrated ability to build, mentor, and lead high-performing CMC teams

  • Proven ability to manage multiple priorities, meet timelines, and perform effectively in a fast-paced environment

  • Commitment to fostering a collaborative, inclusive, and diverse workplace culture.

Desirable Skills, Qualifications, Industry and Educational Requirements

  • Experience in GMP manufacture of radiopharmaceuticals.

  • Sound understanding of regulatory requirements and guidelines governing GMP manufacture of radiopharmaceuticals and quality control (e.g. cGMP, PIC/S, ICH).

$170,000 - $220,000 a year
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