MS&T Capability Trainer, Advanced Therapies Supply Chain MS&T

MS&T Capability Trainer, Advanced Therapies Supply Chain MS&T

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.

We are searching for the best talent for a MS&T Capability Trainer, Advanced Therapies Supply Chain MS&T that can be in either Raritan, NJ.

Purpose : The MS&T Capability Trainer, Advanced Therapies Supply Chain MS&T will be responsible for performing training activities for SMEs who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with MS&T to support personalized cell therapy production through safe and compliant SME training according to cGMP requirements. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups.

Key Responsibilities :

Leads, coaches and delivers a holistic, effective training that supports daily production

Manages, plans, coordinates, prepares and performs hands-on training curriculum in areas of general use, foundational and core skills, systems, unit operations and aseptic processing

Prepares and maintains training lab, materials and equipment

Conducts Observation, Side-by-Side, and Instructor Led Training

Conducts knowledge and skill checks and independent performance qualifications for Operations

Helps write or revise SOPs / Work Instructions, knowledge 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

Supports evaluation of appropriate compliance courses

Performs training for new hires

Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel

Supports investigations and evaluates improvement opportunities for effective compliant training

Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, and increase throughout, capacity and quality compliance

Engage in Gemba walks to identify and record opportunities for process improvement and enhanced process consistency

• This is not an exhaustive or comprehensive listing of job functions; May perform other duties as assigned.

Experience :

University / Bachelors Degree in Science / Engineering or equivalent experience is required; and a minimum of six (6) years of experience within a cGMP environment in the biotech / pharmaceutical industry.

Aseptic manufacturing technique experience is required, and cell and gene therapy cGMP manufacturing experience is preferred.

Hands-on experience and knowledge in manufacturing sciences and operations support is required.

Knowledge of cGMP regulations and FDA / EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices is required.

Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs, and experience in curriculum and module design, is preferred.

Understand key process indicators of the manufacturing process

Strong scientific and technical problem solving and critical thinking skills

Ability to lead with influence

Project management and change management

An ability to build strong partnerships with Manufacturing, Engineering and Quality organizations

Clear and succinct verbal and written communication skill, and advanced computer skills with practical knowledge of MS Office Suite tools

Highly organized and capable of working in a team environment with a positive attitude under minimal supervision

Ability to work with oversight and successfully execute and manage tasks for timely completion; must respond to shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is : $91,000 to $147,200

Additional Description for Pay Transparency : The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits : Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.