Aseptic Operations Process Trainer

Johnson & Johnson Innovative Medicine•Raritan, NJ

3d•Onsite

About The Position

This role will Lead, coach and deliver a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically prepare for commercial supply of a CAR-T product. The company is Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Legend Biotech USA Inc., to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Requirements

A minimum of a Bachelor’s Degree in a Life Sciences field or equivalent technical discipline/experience is required.
A minimum 4 years of relevant work experience is required.
Experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs.
Curriculum and module design experience.
Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems.
Excellent organizational skills.
Ability to effectively prioritize and execute tasks in a fast-paced environment.
Works well in a team-oriented, collaborative environment.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Proactive and continuous improvement oriented.
Ability to lead with influence.
cGMP manufacturing experience
Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
Strong analytical, problem solving and critical thinking skills.

Nice To Haves

Agile Manufacturing
Analytics Dashboards
Chemistry, Manufacturing, and Control (CMC)
Communication
Data Compilation
Data Savvy
Execution Focus
Gap Analysis
Good Manufacturing Practices (GMP)
Issue Escalation
Operational Excellence
Pharmaceutical Industry
Plant Operations
Proactive Behavior
Problem Solving
Process Optimization
Project Administration
Quality Auditing

Responsibilities

Manages, plans, coordinates, prepares and performs hands-on process training curriculum for specific unit operation qualification.
Prepares and maintains training lab, materials, and equipment.
Conducts Observation, Side-by-Side, and Process Qualification activities for new trainees.
Assess technical qualifications of new Operations trainees.
Conducts knowledge and skill checks for Operations.
Work with Operations Management to assess and report on new trainee development.
Work with Operations Management to develop streamlines and robust qualification process.
Helps write or revise Operations training procedures, practices, and skills assessments.
Performs training assessments for new and updated procedures.
Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for Operations.
Supports evaluation of appropriate compliance courses for Operations.
Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel.
Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution.
Knowledge of LMS system.
Supports the maintenance and reporting of quality training metrics.
Support daily manufacturing activities when necessary.

Benefits

medical
dental
vision
time off
consolidated retirement plan (pension)
savings plan (401(k))
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 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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year