Lenti Viral Vector Reinforcement Lead (Duration-based role – 12 Months)

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:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

SUMMARY

The LVV Reinforcement Lead is a 12 month internal assignment established to provide immediate technical, operational, and cross-functional support for Raritan LVV Operations and the Sassenheim LVV manufacturing ramp-up and facility expansion.

The role requires proven site knowledge, active systems access, cross-site experience, and a track record supporting technical execution, investigations, change controls, and operational readiness. The assignment will bridge MSAT, Operations, Quality, Material Sciences, Project Management, and Drug Product partner sites to accelerate execution, reduce onboarding risk, improve first-time quality, and maintain inspection readiness.

KEY RESPONSIBILITIES

Raritan LVV Operations Support

• Lead or coordinate introduction of outsourced buffers for manufacturing, including technical assessment, change control execution, documentation updates, stakeholder alignment, and GMP readiness.

• Support introduction of outsourced single-use sterile tubing sets, including requirements definition, supplier and Quality alignment, material introduction, procedural updates, and operational readiness.

• Drive completion of tangential flow filtration system upgrades, including technical deliverables, qualification or validation requirements, procedure revisions, training impacts, and implementation readiness.

• Lead or support introduction of an automated clarification skid, including process fit assessment, equipment integration, automation readiness, GMP documentation, operational training, and transition to routine use.

Sassenheim Ramp-Up and Expansion Support

• Lead MQ column implementation, including report authorship, technical closeout, and change control closure.

• Update Detailed Process Flow Diagrams (DPFDs) and ensure Maximum Operating Ranges (MORs) are implemented in electronic batch records (eBRs).

• Support sample storage strategy as the Project Management Team representative.

• Develop the isolator design philosophy document in support of the PEM strategy, including cross-contamination controls and alignment with Annex 1 and ISO expectations.

Cross-Site Technical and Quality Support

• Own and coordinate supplier-initiated change controls

• Support Event Triage Sessions, investigations, nonconformances, and CAPAs as manufacturing cadence increases.

• Partner with manufacturing sites, Value Chain Team stakeholders, R&D, Quality, Regulatory, MSAT, Finance, and project teams to coordinate technical activities and meet manufacturing and supply requirements.

• Author, review, and approve technical and quality documents, including protocols, reports, criticality assessments, control strategies, risk assessments, and master plans.

• Monitor process performance, identify trends, develop mitigation plans, and support business continuity strategies.

Expected Outcomes

The 12-month assignment is expected to deliver faster time-to-value, stronger operational continuity, improved inspection readiness, and reduced execution risk across Raritan LVV Operations and the Sassenheim ramp-up.

• Accelerated completion of technical deliverables and change control closure.

• Improved first-time quality, auditability, and inspection readiness.

• Successful implementation of outsourced buffer and sterile tubing set strategies.

• Completion of tangential flow filtration system upgrades and introduction of automated clarification capability.

• Stronger governance for material introduction, supplier changes, process documentation, and site expansion readiness.

• Improved alignment across local and global technical functions.

QUALIFICATIONS

Education:

• Minimum of a Bachelor's degree is required. Focused degree in Engineering, Science or equivalent is preferred.

EXPERIENCE AND SKILLS

Required:

• Minimum 8 years of GMP experience in biopharmaceutical, cell therapy, gene therapy, or LVV manufacturing.

• Strong technical knowledge of manufacturing unit operations, quality systems, change control, investigations, CAPA management, validation, eBRs, and regulated manufacturing documentation.

• Demonstrated ability to lead complex investigations and cross-functional technical projects while influencing peers, leaders, and external partners in a matrixed environment.

Preferred:

• CAR-T and/or LVV production experience in a manufacturing setting.

Other:

• May require up to 10% domestic and/or international travel

• This position is a duration-based role and requires understanding that the anticipated duration may conclude at, prior to, or after 12 months (based on business needs) from one’s start date in this role.

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, external applicants please contact us via J&J Careers Accommodation Support, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research

 

 

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:
o Vacation –120 hours per calendar year
o 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
o Holiday pay, including Floating Holidays –13 days per calendar year
o Work, Personal and Family Time - up to 40 hours per calendar year
o Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
o Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
o Caregiver Leave – 80 hours in a 52-week rolling period10 days
o Volunteer Leave – 32 hours per calendar year
o Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits