Johnson & Johnson Innovative Medicine · 11 hours ago
Principal Cell Therapy Engineer
Spring House, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$100K/yr - $170K/yr
6+ years expJohnson & Johnson Innovative Medicine is dedicated to healthcare innovation aimed at treating complex diseases. They are seeking a Principal Cell Therapy Engineer to shape the manufacturability of the R&D process and support the transfer of CAR-T processes for clinical and commercial manufacturing.
Pharmaceuticals
Responsibilities
Provide Operational expertise in the Technical Operations discussions based upon a combination of GMP knowledge of facility design, knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable to cell and gene therapy products
Provide Operational expertise in the R&D process to support reliable, repeatable, GMP manufacturability of the process in development
Provide Operational guidance to the facility resource model. Leverage the model to shape the product development and operational processes to deliver solutions for cost competitiveness
Lead the development of user requirements for new technology and processes, translate the requirements into operational performance efficiencies and impacts
Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies
Find opportunities for improvement in your area and lead their development and implementation
Immerse yourself in CAR-T processes, build up proven expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records etc., and ensure adequate training of the organization
Ensure end-to-end overview of the flow of all material required in your area, including process material, documents, waste, samples
Identify risks and opportunities in relation to process, contamination, cross-contamination and mix-up control on the shop floor and drive follow-up initiatives for improvement in close cooperation with operators, QA, QC and operations management
Act as a lead in root cause related to safety/quality issues in your area
Act as a spokesperson for your area during health care inspections
Support the lean design and implementation of Information Technology systems (SAP, MES,etc) including future releases to continuously improve performance and compliance
As Ops SME, represent Operations in Process Design and Process Qualification
Instill an approach of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times
Develop an appropriate governance structure to monitor the operational performance of your area at acceptance testing, startup and ongoing
Develop & maintain in depth understanding of the mfg. processes (incl. sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
Develop & maintain robust understanding of aseptic and cell processing techniques
Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)
Understand biosafety
Qualification
Required
Minimum of a Bachelor's or equivalent University Degree required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field
Minimum 6 years of relevant work experience
Experience in one of more of the following areas: cGMP manufacturing, operations technology development, tech transfer, process and equipment validation, and/or quality management
Demonstrated ability to collaborate internally and externally within a matrix environment
You place our patients at the center of everything you do
You embrace diversity, equity, and inclusion
Experience and/or knowledge of GMP shop floor manufacturing processes
You have a start-up/can-do attitude, and you proactively search for solutions
Strong prioritization skills to provide clear instructions to peers
Experience working in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution
Strong verbal and written communication skills with ability to influence without authority
Ability to work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating multi-functional issues
Strong presentation skills to summarize and communicate results
Preferred
Experience with equipment/systems commissioning/qualification/validation, deploying new technology into operations, IT/Automation systems
Experience working in Cell gene therapy(CAR-T)
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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