Director of Radioligand Therapies, Global MSAT (Advanced Therapies) - 2406217818WDescriptionJohnson & Johnson is recruiting a Director of Radioligand Therapies, Global MSAT (Advanced Therapies) to be located in Spring House, PA, Malvern, PA, Raritan, NJ, or potentially remotely within the US.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.Johnson and Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization! We are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. Are you interested in joining a team that is positively impacting patients' lives by growing and scaling our high-quality cell, gene therapy and targeted radioligand therapy products? Apply today for this exciting opportunity to be part of the team!Working closely with Development and Supply Chain teams, this Director of Radioligand Therapy will help establish a manufacturing process for radiopharmaceutical programs that will focus on automation, high throughput, reliability, and lower costs.This includes establishing working relationships with new CMOs, identifying new technologies to ensure high quality and robust supply, and building radio ligand expertise within ATSC. This individual will develop a new product introduction process for radioligand therapies and build out a MSAT team that will provide technical ownership for transfer and manufacture Johnson and Johnson’s first radioligand as part of our Advanced Therapies supply chain. This role partners closely with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow.Essential functions:
Technical SME for radioligand process, build radioligand capabilities within the Advanced Therapies MSAT organization.
Establish Advanced Therapies Supply Chain process for technical transfer of radioligand therapies into commercial production, including launch support and capacity expansions once operational.
Accountable for the delivery of key project milestones for technology transfers end-to-end.
Provide technical support and oversight for planning and execution of manufacturing site activities from transfer through scale-up.
Proactive risk mitigation and issue escalation (i.e., perform gap assessments, FMEA, process equipment evaluation)
Ensure key performance indicators, CAPEX estimates, FTE estimates, and dashboards are maintained
Implement digital/data analytics capabilities throughout the manufacturing process and supply chain to maximize data transparency, enabling ease of reporting results/data analysis of manufacturing processes
Build technology platforms/standard work to accelerate development timelines, and streamline the technical transfer process.
Qualifications
University/Bachelor’s degree in Engineering or Equivalent with 10-12 Years work experience. MBA/Masters/PhD degree preferred.
Outstanding communication skills and judgment. Able to prioritize and decide appropriate courses of actions.
Effective at implementing decisions, troubleshooting and problem-solving skills in a fast-paced environment.
Previous experience in development or GMP support of radioligands, radio pharmaceuticals or nuclear medicine is highly preferred.
Strong project management skills is required.
Hands-on experience and knowledge in manufacturing operations and technology transfer, process comparability, process monitoring, change management, cGMP compliance, and advanced therapies (ie. radio pharmaceuticals) product regulatory and validation requirements is highly preferred.
Ability to lead and influence multidisciplinary, cross-functional teams in an international environment including travel to global network of manufacturing sites is required.
Previous experience with radiotherapy manufacturing and knowledge of radiation safety regulations is a plus.
This role can be based in various location and may require up to 25% travel.
The anticipated base pay range for this position is 157000 to 271400.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.· Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).· This position is eligible to participate in the Company’s long-term incentive program.· Employees are eligible for the following time off benefits:o Vacation – up to 120 hours per calendar yearo Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearo Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year· Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefitsThe compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."Primary Location NA-US-Pennsylvania-Spring HouseOther Locations NA-United States, NA-US-New Jersey-Raritan, NA-US-Pennsylvania-MalvernOrganization JANSSEN SUPPLY GROUP, LLC (6046)Relocation Eligible: Yes - Within CountryTravel Yes, 25 % of the TimeJob Function Multi-Family R&D OperationsReq ID: 2406217818W