Job Function:
Project/Program Management Group
Job Sub Function:
Project/Program Management
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America
Job 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
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:
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 - $212,750.00
Additional 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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
