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Johnson & Johnson Innovative Medicine · 16 hours ago

MSAT Technical Steward, Advanced Therapies Supply Chain (ATSC)

Raritan, NJ

Full-time

Onsite

Entry, Mid Level

$79K/yr - $128K/yr

2+ years exp

Johnson & Johnson Innovative Medicine is dedicated to healthcare innovation, aiming to prevent, treat, and cure complex diseases. The MSAT Technical Steward will lead the technical implementation of CAR-T projects, overseeing process improvements and ensuring high-quality product delivery through collaboration with internal and external stakeholders.

Pharmaceuticals

Responsibilities

Act as technical lead for site projects, focused on process changes/improvements and assume global technical lead responsibilities as needed

Identify opportunities for process improvement and lead end-to-end implementation of such changes

Generate and present business cases for endorsement of projects with significant value drivers (i.e. cost/value optimization, increase reliability to our patients and/or supply chain resiliency)

Prepare process risk assessments, perform technical assessments, drive change controls, and provide technical/scientific recommendations to support implementation of such changes

Design and execute GMP studies to support improvements: draft protocols, oversee execution, and prepare reports

Support GMP manufacturing implementation through process design qualification, enterprise system interface engineering, and vendor evaluation

Own process knowledge for cell and gene therapy manufacturing to support tech transfers into/out of the Raritan facility; write and review transfer plans, protocols, and reports

Perform Gemba walks to capture operational insights and translate them into actionable process-improvement opportunities

Provide technical support and expertise to Manufacturing, ensuring seamless flow of knowledge and information across functions and sites

Interface with TDS/CMC, external vendors, and cross-functional teams to drive automation platform design and evaluate new raw materials/consumables

Qualification

CellGene TherapyProject ManagementManufacturing SciencesTechnology TransferCGMP ComplianceAnalytical ReasoningProcess EngineeringLean Supply Chain ManagementTechnical ResearchProblem Solving

Required

University/Bachelors Degree in Science/Engineering or Equivalent with a minimum of 2-4 Years Biotech / Pharmaceutical experience or equivalent industry experience

Hands-on experience and knowledge in manufacturing sciences and operations support, technology transfer, change management, cGMP compliance, and product regulatory and validation requirements are required

Project management experience is required

Ability to collaborate with stakeholders to understand their needs, translate them into technical requirements, and ensure alignment between technical and business objectives

Ability to create and maintain project roadmaps, estimate timelines and resources, identify risks and mitigations, and ensure that projects are executed according to defined technical plans

Demonstrated strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability

Able to build strong partnerships with Manufacturing, Engineering, Quality, Development and Collaboration Partners

Provide clear and succinct verbal and written communication skills

Able to accommodate shift work including evenings and weekends as required by the manufacturing process. Accommodate unplanned overtime on little to no prior notice

This role may require up to 10% travel as needed

Preferred

Cell and gene therapy process experience is preferred

Analytical Reasoning

Computerized Equipment Skills

Emerging Technologies

Gemba Kaizen

Issue Escalation

Lean Supply Chain Management

Problem Solving

Process Control

Process Engineering

Process Oriented

Product Improvements

Science, Technology, Engineering, and Math (STEM) Application

Situational Awareness

Supply Planning

Technical Research

Technologically Savvy

Validation Testing

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