Operations Manager

Legend Biotech; Raritan (NJ); On-site; USD 127,313 - 167,099; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Paid time off including vacation and holidays

Job summary

Legend Biotech is looking for an Operations Manager (2nd Shift) to oversee the production of personalized cell therapy in a cGMP environment. This position involves managing operations, staff performance, and ensuring compliance with manufacturing standards.

The ideal candidate will have a Bachelor's degree in Engineering or a related field, with at least 5 years of operations experience and a strong focus on cell/gene therapy. The role is based in Raritan, New Jersey and includes various benefits.

Compensation ranges between $127,313 and $167,099 USD, with bonuses and comprehensive benefits available for full-time employees.

Qualifications

• Minimum of 5 years of operations experience in a cGMP environment.
• At least 3 years of supervisory experience.
• Experience with Cell/Gene Therapy preferred.

Responsibilities

• Oversee cell therapy production and ensure compliance with cGMP.
• Manage staff performance and assign personnel for daily production.
• Lead facility operating review meetings and drive improvements.

Skills

Collaboration

Analytical skills

Problem-solving

Project management

Education

Bachelor’s degree in Engineering or related field

Tools

Manufacturing Execution Systems (MES)

Enterprise Resource Planning (ERP)

Job description

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. Our three R&D sites worldwide apply these innovative technologies to pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.

Legend Biotech has entered into a global collaboration agreement with Janssen, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucel (cilta‑cel). The partnership combines the strengths and expertise of both companies to advance an immunotherapy in the treatment of multiple myeloma.

Operations Manager (2nd Shift)

Role Overview

The CAR‑T Operations 2nd Shift Manager is an exempt level position within Technical Operations. This individual will oversee the production of personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. The position is onsite, Monday to Friday, on the 2nd shift.

Key Responsibilities

• Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Serve as site management resource and point of contact for all 2nd shift employees.
• Act as the primary point of contact for 2nd shift Technical Operations supervisors within their respective areas of oversight.
• Take direction and guidance from the Associate Director and/or Senior Managers of the process areas.
• Hire, develop, and manage staff performance; assign personnel to execute daily production schedules.
• Create and revise operational procedures, including manufacturing work instructions, master batch records, and forms.
• Manage multiple work centers to ensure high quality and compliant product supply; oversee production metrics.
• Support manufacturing investigations, manage change controls, maintain inspection readiness, and actively support regulatory inspections.
• Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
• Lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Establish key relationships with internal and external stakeholders; interact with all levels within the organization.

Requirements

• Bachelor’s degree in Engineering or related field, or equivalent experience.
• Minimum of 5 years of operations experience within a cGMP environment in the biotech/biopharma industry, with at least 3 years of supervisory experience; Cell/ Gene Therapy experience preferred.
• Ability to build strong partnerships and effectively collaborate in a matrixed environment.
• Ability to work independently, prioritize and manage multiple tasks simultaneously, and balance competing priorities.
• Capacity to manage shifting priorities, meet critical deadlines in a fast‑paced and dynamic environment, and provide clear direction to team members.
• Clear and succinct verbal and written communication skills.
• Strong analytical, problem‑solving, and critical‑thinking skills; ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Basic project management skills and responsiveness to issues; demonstrated passion for creating new medicines.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.
• Ability to accommodate shift work, including daily overtime, weekends, and unplanned overtime on short notice.
• GMP compliance and regulatory knowledge: deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.
• GMP compliance and regulatory knowledge is a requirement; familiarity with modern manufacturing system technologies is an asset.

Compensation and Benefits

Base pay range: $127,313 USD – $167,099 USD. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed in accordance with applicable laws.

Other types of pay: performance‑based bonus and/or equity available to employees in eligible roles.

Benefits and paid time off: Medical, dental, and vision insurance; 401(k) retirement plan with a company match that vests fully on day one; eight (8) weeks of paid parental leave after three (3) months of employment; paid time off including vacation, personal, sick time, floating holidays, and eleven (11) company holidays; voluntary benefits such as flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental pet, critical illness, accident, and hospital indemnity insurance; voluntary commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer recognition programs.

These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to 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, 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.