Spring House, Pennsylvania, United States of America, United States of America
Hybrid
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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Project/Program Management GroupJob Sub Function:
Project/Program ManagementJob Category:
ProfessionalAll Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way!
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for an MSAT Principal Scientist to join our Team! This is an onsite/hybrid role.
Summary
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! Location Raritan, NJ (USA).
The Principal Scientist we are looking for is responsible for leading complex, global investigations and improvement and harmonization projects across the Carvykti network of the Advanced Therapies Supply Chain. You will also be responsible for Life-Cycle Management projects that will drive reliability, innovation and sustainability in our processes and manufacturing plants, both internally and externally. In this role, you will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow. The Principal Scientist will work in close collaboration with other global and local roles and must have strong communication skills to influence other functions and management levels outside of their own group. In this role you will effectively lead global and cross-organizational teams to generally attain desired results for all parties. Solid technical understanding in cell and gene therapy manufacturing processes under GMP conditions is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable.
Key Responsibilities:
Partner cross-functionally with the Value Chain Team (VCT) and manufacturing sites owning the coordination of technical activities to ensure manufacturing and supply demands are met.
Lead and Execution of technical projects that will enhance manufacturing output through optimization and harmonization across production sites. Your efforts will have a direct impact on patient supply!
Lead improvement and innovation initiatives includes building project business case; partner with R&Dsite functions and finance to identify COGS improvement opportunities (COGS optimization process)
Author, review and approval of product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.)
Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans.
Act as Process SME: proactively monitor technical process and product performance to detect trends and develop mitigation plans.
Maintain a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management and tech transfers for product
Qualifications
Required:
Master’s degree in engineering or Equivalent with 8-10 years work experience. PhD degree preferred.
Detailed technical knowledge of biopharmaceutical manufacturing site unit operations (DS and/or DP) under GMP conditions.
Demonstrated competency and experience leading complex investigations with cross-functional teams.
Ability to influence and lead peers, superiors, and external partners.
Preferred:
Experience with CAR-T and/or (lenti)viral vector products and production under (BSL-2) BioSafety conditions.
Knowledge of manufacturing site systems and procedures (SAP, event and complaint handling, change control, qualification, Process Validation, Continued Process Verification, etc.)
Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams. Organizing, coordinating teams, and setting up and maintaining communication with stakeholders and wider network organization.
Project management skills; capable of effective integration of deliverables and support execution at the manufacturing site level.
Motivated, self-starter able to work independently with demonstrated problem-solving skills.
Good knowledge of Quality and Compliance, and regulatory requirements.
Other:
Fluent in written and spoken English
10-25% travel may be required, depending on project needs
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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
Required Skills:
Preferred Skills:
Agile Decision Making, Agility Jumps, Analytics Insights, Business Alignment, Continuous Improvement, Cross-Functional Collaboration, Leadership, Organizational Project Management, Organizing, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW), Technical Credibility
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Want to know if this job is worth applying to?