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Director, CMC Operations

4 months ago

Somerset, United States Perspective Therapeutics Full time
Job DescriptionJob DescriptionObjective
The Director, CMC Operations responsible for technically designing, managing, and executing a plan for the use of alpha emitting Pb-203 & Pb-212 radiopharmaceuticals and the manufacturing of drug candidates supporting clinical trials and readiness for commercial deployment.  S/he will act as a champion and advocate for a strategic vision in technical operations, aligning with the company’s long-term goals and implementing a robust supply chain strategy.Essential Functions
  • Formulate an operational plan for the development of radioisotope and drug candidates, orchestrating a seamless transition to efficient manufacturing processes involving the identification and implementing optimal manufacturing methods, equipment, and facilities.
  • Elevate internal technical and operational capabilities by implementing continuous monitoring, improvement, and troubleshooting protocols within the realm of process manufacturing, encompassing in-process control, QC, and release time.
  • Foster a strong operational culture by establishing and reinforcing GMP and quality standards within the organization.
  • Conceptualize new processes and facilities that accommodate the evolving platform, progressing from preclinical to commercial levels.
  • Lead, inspire, and manage a CMC department, including engineers, pharmacists, and scientists, ensuring the timely delivery of projects within budget constraints while upholding safety and quality standards.
  • Harness insights from experience in radioisotope generator and drug candidates manufacturing to enhance the company process continually.
  • Cultivate and sustain relationships with key suppliers and service providers, ensuring a dependable and efficient supply chain for raw materials, equipment, and services.
  • Ensure strict compliance with relevant regulations, standards, and guidelines, emphasizing quality, safety, and environmental impact across CDMOs, internal R&D, and proprietary projects.
  • Identify and implement process improvements to enhance efficiency, reduce costs, and elevate the safety and quality of products and services provided.
  • Provide essential support for the approval of the company’s manufacturing sites, ensuring adherence to GMP, HSE, and QA standards.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education/Experience
  • PharmD or a PhD in Chemistry, Chemical Engineering, Nuclear Engineering, Radiopharmaceuticals, or a closely related field.
  • Minimum of 10 years of hands-on experience in the radiopharmaceutical sector, specializing in manufacturing and process development.
  • Proven track record in developing and managing intricate technologies, preferably in the domain of radioligand therapy.
  • Familiarity with pertinent regulations (FDA, EMA), standards, and guidelines, emphasizing quality, safety, and environmental impact considerations.
  • Comprehensive understanding of regulatory requirements related to drug development, with a keen awareness of current US and EU regulations for therapeutic products.
  • Must possess profound technical expertise and adept problem-solving skills in nuclear physics, materials science, and radiopharmaceuticals, coupled with the ability to think strategically and communicate seamlessly with all stakeholders.
  • Experience with MS Office Suite required.
Knowledge / Skill / Ability
  • Exceptional organizational and project management proficiency, which highlight the capability to prioritize and handle multiple tasks concurrently.
  • Ability to convey complex ideas in a simple manner to management and customers.
  • Ability to understand and communicate scientific or technical information.
  • Ability to work across multi-disciplinary groups and lead decision-making discussions.
  • Excellent interpersonal, negotiation, communication, and collaborative skills.
  • Demonstrated record of high productivity and results.
  • Ability to travel up to 25%.
Work Environment 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
  • Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • May be required to sit or stand for long periods of 8+ hours a day while performing duties. 
  • Willingness to complete safety training within allotted time limits, and work in a team-based environment.
For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

 

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