New Jersey Staffing
Associate Director, MSAT (Advanced Therapies)
New Jersey Staffing, Raritan, New Jersey, us, 08869
Associate Director, MSAT (Advanced Therapies)
Johnson and Johnson Innovative Medicines is recruiting for the Manufacturing Science and Technology 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 ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the team! The Associate Director serves as part of the Global Technical Team, reporting to the Director, MSAT LCM within 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. You will be responsible for: Partnering cross-functionally across the MSAT organization and site operations, owning the coordination of all technical activities at the contract manufacturer. Providing technical leadership and strategic direction for manufacturing processes, ensuring scalability and robustness. Leading the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans. Proactively monitoring technical process and product performance to detect trends and develop mitigation plans. Collaborating closely with R&D, Quality, Regulatory, and Manufacturing teams to identify and resolve technical challenges. Reviewing technical product & process risk profiles and criticality analysis. Developing and implementing manufacturing process improvements, validation strategies, and troubleshooting plans. Supporting regulatory filings by preparing technical documentation and responding to agency inquiries. Driving innovation by evaluating new manufacturing technologies, equipment, and methodologies. Ensuring compliance with cGMP regulations, safety standards, and corporate policies. Interfacing with the CMO leadership to align on project timelines, budgets, and quality expectations. Contributing to the development of the long-term supply strategy including scenario development and E2E impact analysis. Collaborating with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process). Leading improvement/innovation opportunities, to build project business cases and to prioritize projects (product related). Democratizing process information across sites. Authoring "why" modules and training operations/quality on scientific basis of the process. Supporting failure investigations (escalation of quality or compliance events). Executing or following-up on execution of technical projects. Presenting to health authorities during inspections. Developing validation approaches and technical strategy for implementation of key initiatives. Identifying and overseeing 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. Partnering cross-functionally and championing to develop strategies for comparability exercises to enable change implementation. Ensuring technical and manufacturing product requirements are addressed throughout lifecycle of new solutions. Authoring and reviewing technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions. Creating, maintaining, and upgrading product technical knowledge as an element of the value chain knowledge infrastructure. Performing internal and external benchmarking activities. 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. Qualifications: A Bachelor's Degree in Science/Engineering or Equivalent with 8-10 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. Works in an international environment across different time zones. Travel: up to 20% - project dependent. 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 vertebras and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. The anticipated base pay range for this position is $120,000 to $207,000. Additional Description for Pay Transparency: 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.
Johnson and Johnson Innovative Medicines is recruiting for the Manufacturing Science and Technology 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 ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the team! The Associate Director serves as part of the Global Technical Team, reporting to the Director, MSAT LCM within 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. You will be responsible for: Partnering cross-functionally across the MSAT organization and site operations, owning the coordination of all technical activities at the contract manufacturer. Providing technical leadership and strategic direction for manufacturing processes, ensuring scalability and robustness. Leading the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans. Proactively monitoring technical process and product performance to detect trends and develop mitigation plans. Collaborating closely with R&D, Quality, Regulatory, and Manufacturing teams to identify and resolve technical challenges. Reviewing technical product & process risk profiles and criticality analysis. Developing and implementing manufacturing process improvements, validation strategies, and troubleshooting plans. Supporting regulatory filings by preparing technical documentation and responding to agency inquiries. Driving innovation by evaluating new manufacturing technologies, equipment, and methodologies. Ensuring compliance with cGMP regulations, safety standards, and corporate policies. Interfacing with the CMO leadership to align on project timelines, budgets, and quality expectations. Contributing to the development of the long-term supply strategy including scenario development and E2E impact analysis. Collaborating with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process). Leading improvement/innovation opportunities, to build project business cases and to prioritize projects (product related). Democratizing process information across sites. Authoring "why" modules and training operations/quality on scientific basis of the process. Supporting failure investigations (escalation of quality or compliance events). Executing or following-up on execution of technical projects. Presenting to health authorities during inspections. Developing validation approaches and technical strategy for implementation of key initiatives. Identifying and overseeing 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. Partnering cross-functionally and championing to develop strategies for comparability exercises to enable change implementation. Ensuring technical and manufacturing product requirements are addressed throughout lifecycle of new solutions. Authoring and reviewing technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions. Creating, maintaining, and upgrading product technical knowledge as an element of the value chain knowledge infrastructure. Performing internal and external benchmarking activities. 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. Qualifications: A Bachelor's Degree in Science/Engineering or Equivalent with 8-10 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. Works in an international environment across different time zones. Travel: up to 20% - project dependent. 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 vertebras and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. The anticipated base pay range for this position is $120,000 to $207,000. Additional Description for Pay Transparency: 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.