Training Supervisor

Merck & Co.; Raritan (NJ); On-site; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Legend Biotech in Raritan, NJ, is seeking a Training Supervisor to lead the Training team supporting clinical and commercial CAR-T production in a cGMP environment.

You will oversee curriculum development, training assessments and qualifications, and ensure compliant operations while coordinating with Operations and Quality teams for a fast-paced manufacturing ramp-up.

Qualifications

• Bachelor's Degree in Science, Information Science or equivalent technical discipline.
• 6+ years of relevant work experience in aseptic manufacturing, training, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to cell-based products.
• Ability to manage shifting priorities and meet deadlines in a fast-paced environment.
• Strong analytical, problem-solving and critical thinking skills.
• Excellent verbal and written communication.
• Experience with MS Office, SharePoint and related systems.

Responsibilities

• Lead and develop a comprehensive training program for all plant functions supporting clinical production and commercial supply of CAR-T products.
• Manage scheduling and deployment of the training curriculum.
• Conduct training assessments and qualification oversight.
• Oversee compliance training and system upgrades.
• Collaborate with cross-functional leads to align procedures by role.
• Serve as SME for Compliance and Training systems and audits.

Skills

Training leadership

LMS knowledge

cGMP knowledge

Project management

MS Office

Strong communication

Education

Bachelor's degree in Science or related

Tools

SharePoint

MS Office Suite

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in-vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Training Supervisor as part of the Operations team based in Raritan, NJ.

Role Overview

The position will be responsible for supervising the training team who lead training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will oversee the Training team members in collaboration with department management in Operations and Quality to support personalized cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support organization build and rampup of clinical production and facility approval of a state of-the-art cell therapy facility for commercial launch and sustained production. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Leads, directs, coaches and develops a holistic, effective training program for all plant functions and personnel that support daily clinical production and strategically prepares for commercial supply of a CAR-T product.
• Manages training team to plan, coordinate, prepare and deploy training curriculum.
• Perform training assessments for new and updated procedures.
• Oversee and schedule training skill checks and qualifications.
• Support evaluation of appropriate compliance courses.
• Leads and works with training team to manage training requirements for new hires.
• Work collaboratively with functional leads for procedure alignment based on roles.
• Serve as subject matter expert for Compliance & Training systems.
• Make recommendation for future system upgrades.
• Troubleshoot problems reported by system users.
• Knowledge of LMS system.
• Maintain and report quality training metrics.
• Prepares information for internal and external audits.

Requirements

• A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 6 years relevant work experience is required. It is preferable that the candidate have 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.
• Must be 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 and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems.
• Good verbal and written communication skills.
• 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.
• 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.
• Project management.
• Change management

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off

• Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$96,267—$126,351 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.