J&J Family of Companies
Director, MSAT
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. We are searching for the best talent for a Director, MSAT that can be in either Raritan, NJ or Ghent, Belgium. Purpose: The Director, MSAT serves as part of the Global MSAT team, reporting to the Lifecycle Management Global Head on the Advanced Therapies Manufacturing Science and Technology Organization. They are the single point of contact at the manufacturing site for the technical team, responsible for driving implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products. Example focus areas include projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today and tomorrow. Responsibilities: Serve as global technical owner for Carvykti network. Lead a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management and tech transfers for products Partner cross-functionally with the Value Chain Team (VCT), owning the coordination of all technical activities. Define and own the MSAT Product Roadmap for Carvykti. Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis. Proactively monitor technical process and product performance to detect trends and develop mitigation plans through site MSAT teams. Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans. Collaborate with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process) across network of sites. Lead improvement/innovation opportunities, to build project business cases and to prioritize projects (product related) through network of sites. Democratize process information across sites Author "why" modules and train operations/quality on scientific basis of the process Identify and oversee implementation (in partnership with DPDS) of lifecycle management, new technology and automation projects at the manufacturing sites to improve robustness, scalability and cost/cycle time/quality performance for approved products Ensure technical and manufacturing product requirements are addressed throughout lifecycle of new solutions Author and review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions Create, maintain, and upgrade product technical knowledge as an element of the value chain knowledge infrastructure Perform internal and external benchmarking activities Reviews technical product & process risk profiles and criticality analysis Autonomy and Complexity: Represent the area for site wide/global projects as required. Lead troubleshooting of routine manufacturing processes. Endlessly curious, seeking to understand the "why" behind complex scientific topics. Develop, lead and influence implementation of innovative solutions to ensure competitiveness, product quality and process capability improvements. Can-do mentality, agility & high flexibility able to work with stretched goals and deadlines. Experience: University/Bachelor's Degree in Science/Engineering with 10-12 Years Biotech/Pharmaceutical experience or equivalent industry experience; OR a Masters/PhD degree in Engineering, with 4-6 years Biotech/Pharmaceutical experience or equivalent industry experience. Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. cell/gene therapy products, vaccines, or any other advanced therapy products) Experience leading the coordination of tech transfer activities and technical services for cell/gene therapies. Expert knowledge of cell and gene manufacturing processes. Expert knowledge of GMP/quality considerations for commercial manufacturing. Expert knowledge of evolving ATMP health authority expectations/regulations. Expert knowledge of data analytics/sciences and process automation. Able to work in an international environment across different time zones. Ability to travel up to 20% depending on the project. Knowledge of Data Analytics/Statistical Analysis Tools. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is: $146,000 to $251,850 USD Annual. 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)). Employees are eligible for the following time off benefits: vacation
up to 120 hours per calendar year, sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington
up to 56 hours per calendar year, holiday pay, including Floating Holidays
up to 13 days per calendar year, work, personal and family time - up to 40 hours per calendar year. Additional information can be found through the link below.
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. We are searching for the best talent for a Director, MSAT that can be in either Raritan, NJ or Ghent, Belgium. Purpose: The Director, MSAT serves as part of the Global MSAT team, reporting to the Lifecycle Management Global Head on the Advanced Therapies Manufacturing Science and Technology Organization. They are the single point of contact at the manufacturing site for the technical team, responsible for driving implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products. Example focus areas include projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today and tomorrow. Responsibilities: Serve as global technical owner for Carvykti network. Lead a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management and tech transfers for products Partner cross-functionally with the Value Chain Team (VCT), owning the coordination of all technical activities. Define and own the MSAT Product Roadmap for Carvykti. Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis. Proactively monitor technical process and product performance to detect trends and develop mitigation plans through site MSAT teams. Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans. Collaborate with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process) across network of sites. Lead improvement/innovation opportunities, to build project business cases and to prioritize projects (product related) through network of sites. Democratize process information across sites Author "why" modules and train operations/quality on scientific basis of the process Identify and oversee implementation (in partnership with DPDS) of lifecycle management, new technology and automation projects at the manufacturing sites to improve robustness, scalability and cost/cycle time/quality performance for approved products Ensure technical and manufacturing product requirements are addressed throughout lifecycle of new solutions Author and review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions Create, maintain, and upgrade product technical knowledge as an element of the value chain knowledge infrastructure Perform internal and external benchmarking activities Reviews technical product & process risk profiles and criticality analysis Autonomy and Complexity: Represent the area for site wide/global projects as required. Lead troubleshooting of routine manufacturing processes. Endlessly curious, seeking to understand the "why" behind complex scientific topics. Develop, lead and influence implementation of innovative solutions to ensure competitiveness, product quality and process capability improvements. Can-do mentality, agility & high flexibility able to work with stretched goals and deadlines. Experience: University/Bachelor's Degree in Science/Engineering with 10-12 Years Biotech/Pharmaceutical experience or equivalent industry experience; OR a Masters/PhD degree in Engineering, with 4-6 years Biotech/Pharmaceutical experience or equivalent industry experience. Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. cell/gene therapy products, vaccines, or any other advanced therapy products) Experience leading the coordination of tech transfer activities and technical services for cell/gene therapies. Expert knowledge of cell and gene manufacturing processes. Expert knowledge of GMP/quality considerations for commercial manufacturing. Expert knowledge of evolving ATMP health authority expectations/regulations. Expert knowledge of data analytics/sciences and process automation. Able to work in an international environment across different time zones. Ability to travel up to 20% depending on the project. Knowledge of Data Analytics/Statistical Analysis Tools. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is: $146,000 to $251,850 USD Annual. 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)). Employees are eligible for the following time off benefits: vacation
up to 120 hours per calendar year, sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington
up to 56 hours per calendar year, holiday pay, including Floating Holidays
up to 13 days per calendar year, work, personal and family time - up to 40 hours per calendar year. Additional information can be found through the link below.