Current jobs related to Director, CMC Operations - Trenton - Perspective Therapeutics, Inc


  • Trenton, New Jersey, United States Jobot Full time

    About the RoleWe are seeking a highly experienced Senior Director of Process Development to join our team at Jobot. As a key member of our organization, you will be responsible for leading the development of robust, high-performing processes for gene therapy applications, ensuring compliance with industry standards and regulations.Key ResponsibilitiesDevelop...


  • Trenton, New Jersey, United States Proclinical Staffing Full time

    Job SummaryWe are seeking a highly skilled Regulatory Operations Manager to lead our regulatory operations activities and manage US and global submissions for the Regulatory CMC group.Key ResponsibilitiesLead regulatory operations activities and manage US and global submissions.Ensure creation of high-quality regulatory submissions packages that align with...


  • Trenton, New Jersey, United States Healthcare Nursing Center Full time

    Director of Maintenance Job DescriptionWe are seeking a highly skilled and experienced Director of Maintenance to oversee the upkeep of our facilities at Healthcare Nursing Center, a Skilled Nursing Facility located in Ocean County.The successful candidate will be responsible for ensuring that our facilities meet current federal, state, and local standards...


  • Trenton, New Jersey, United States LibraryLinkNJ Full time

    Job SummaryThe Board of Trustees of LibraryLinkNJ seeks an experienced and enthusiastic leader to oversee the daily operations of our public library. As the Director of Library Operations, you will be responsible for managing the library's services, staff, and resources to ensure the delivery of high-quality programs and services to the community.Key...


  • Trenton, New Jersey, United States Proclinical Staffing Full time

    Sr. Manager, Regulatory Operations ManagementProclinical Staffing is seeking a highly skilled and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group.Key...


  • Trenton, New Jersey, United States CSI International Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Engineering and Operations to join our team at CSI International. This is a key leadership position that requires a strong technical background, excellent communication skills, and the ability to manage and coordinate multiple projects and teams.Key ResponsibilitiesLeadership and...


  • Trenton, New Jersey, United States Jobot Full time

    Director of Engineering Lead Impactful ProjectsAs a Director of Engineering, you will lead impactful projects in civil engineering across the mid-Atlantic region. Our team is dedicated to providing comprehensive engineering solutions, and we are seeking a talented individual to join us in this role.Key Responsibilities:Collaborate with a dedicated team to...


  • Trenton, New Jersey, United States Gentiva Hospice Full time

    About the RoleGentiva Hospice is seeking an experienced and compassionate Executive Director - RN to lead our team in Hamilton Township, NJ. As a key member of our leadership team, you will be responsible for the day-to-day operations of our hospice location, ensuring the highest level of quality care and service to our patients and their families.Key...


  • Trenton, New Jersey, United States Jobot Full time

    Director of Engineering LeadJoin Jobot as a Director of Engineering Lead impactful projects in civil engineering across the mid-Atlantic region.About JobotWe are a Small Business Enterprise, serving clients in civil engineering, environmental solutions, surveying, and landscape architecture since 1991 across the mid-Atlantic region.Collaborate with a...


  • Trenton, New Jersey, United States Quality Life Services Mercer Full time

    About the RoleWe are seeking an experienced and compassionate Assistant Director of Nursing to join our team at Quality Life Services Mercer. As a key member of our nursing department, you will be responsible for managing the daily operations of our skilled nursing facility.Key ResponsibilitiesLeadership and Management: Provide guidance and oversight to our...


  • Trenton, New Jersey, United States Gentiva Hospice Full time

    About the RoleGentiva Hospice is seeking an experienced and compassionate Executive Director - RN to lead our team in Hamilton Township, NJ. As a key member of our leadership team, you will be responsible for the day-to-day operations of our hospice location, ensuring the highest level of quality care and service to our patients and their families.Key...

  • Operations Director

    2 weeks ago


    Trenton, New Jersey, United States Givaudan Full time

    About the RoleGivaudan is seeking an experienced Operations Director to lead our Mount Olive, NJ site, which is the second largest Fragrance & Beauty compounding site globally. As a key member of the AMERICAS Operations Team, you will be responsible for implementing and sustaining effective operations, covering safety, health, and environmental protection,...


  • Trenton, United States Proclinical Staffing Full time

    Sr. Manager, Regulatory Operations Management- Contract - New JerseyProclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Primary...


  • Trenton, United States Proclinical Staffing Full time

    Sr. Manager, Regulatory Operations Management- Contract - New JerseyProclinical is seeking a dedicated and detail-oriented individual for the role of Sr. Manager, Regulatory Operations and Submission Management. This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Primary...


  • Trenton, United States PTC Therapeutics Full time

    Job Description Summary: The Contractor, Patent Attorney/Patent Agent supports PTC's global Intellectual Property (IP) needs. As a member of the Intellectual Property Department, Patent Counsel will interface with internal IP Counsel, Legal Department and Legal Operations Teams, and will collaborate closely with PTC Stakeholders in Research, Preclinical,...


  • Trenton, New Jersey, United States Lancer Hospitality Full time

    About the RoleWe are seeking a highly motivated and experienced Executive Director of Food Service Operations to join our team at Lancer Hospitality. As a key member of our culinary team, you will be responsible for leading a talented team of food service professionals and managing all aspects of our food service department to ensure exceptional customer...


  • Trenton, New Jersey, United States BetMGM LLC Full time

    About UsBetMGM LLC is a leading online gaming company that is revolutionizing the sports betting and online gaming industry in the United States. We are a partnership between two powerhouse organizations—MGM Resorts International and Entain Group. Our company is known for its exciting portfolio of brands, including BetMGM Sportsbook, Borgata online, Party...

  • Operations Director

    2 weeks ago


    Trenton, New Jersey, United States Atavas Full time

    Operations ManagerAtavas is seeking a seasoned professional to oversee the day-to-day operations at our New Jersey facility. The ideal candidate will have a strong background in managing plant, yard, maintenance, and quality control teams.Key Responsibilities:Develop and implement production forecasts to drive efficiency and reduce hoursReduce overtime and...

  • Maintenance Director

    2 weeks ago


    Trenton, New Jersey, United States Healthcare Nursing Center Full time

    Job Title: Director of MaintenanceJob Summary:We are seeking a highly skilled and experienced Director of Maintenance to join our team at Healthcare Nursing Center. As a key member of our operations team, you will be responsible for overseeing the upkeep of our facilities to ensure they meet the highest standards of safety, cleanliness, and comfort for our...


  • Trenton, New Jersey, United States CSI International, Inc. Full time

    Job Title: Director of EngineeringCSI International, Inc. is seeking a highly skilled and experienced Director of Engineering to lead our Mechanical Engineering Division. As a key member of our team, you will be responsible for overseeing the administrative, financial, and operating aspects of our facilities.Key Responsibilities:Direct and coordinate all...

Director, CMC Operations

4 months ago


Trenton, United States Perspective Therapeutics, Inc Full time

Objective 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. Qualifications

To 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.

#J-18808-Ljbffr