BioSpace
Overview
Legend Biotech is seeking a
Director of Operations
as part of the
Technical Operations
team based in
Raritan, NJ . This exempt role is responsible for overseeing the production of personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.
Key Responsibilities
Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
Lead a ~250+ organization responsible for either the non-sterile or sterile manufacturing processes in a 24/7 operation and assign personnel to execute daily production schedules.
Direct 3-6 reports ranging from Associate Director, Senior Manager, and Manager.
Oversee hiring, development, and performance management of staff in a growing operation in terms of volume/output and team size.
Manage multiple work centers within the facility to ensure high quality and compliant product supply, overseeing production metrics (employee engagement, safe behavior, quality performance, schedule adherence, and productivity improvements).
Support manufacturing investigations, manage change controls, and maintain inspection readiness; actively support regulatory inspections.
Lead facility operating review meetings and sponsor department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
Support organizational design updates, operations organization build, and ramp-up of commercial and clinical capacity.
Build strong partnerships with Manufacturing, Supply Chain, Engineering, MS&T, and Quality to ensure seamless daily production schedules.
Provide clear leadership to drive effective communication, coordination, and collaboration across cross-functional groups for robust production, testing, and release of product to patients.
Serve as the delegate for the Head of Operations and establish key stakeholder relationships with internal and external partners.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field (required).
Advanced degree (MS, MBA, or PhD) preferred.
Minimally 12+ years of combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation, or quality management; preference for Cell/Gene Therapy experience.
Minimum of 5 years of progressive leadership roles in a cGMP operation, with prior biologics and/or cell therapy operations experience preferred.
Proven ability to lead large, multi-level teams and develop cohesive, high-performing teams with strong succession planning.
Effective communication with people at all levels and the ability to make timely decisions under pressure.
Strong teamwork, interpersonal skills, and ability to influence across levels.
Experience in a growth environment managing fast-paced change, balancing daily operations with long-term planning.
Track record of leading audits and inspections (FDA, EMA, etc.).
Ability to work independently, prioritize, manage multiple tasks, and balance cross-functional issues.
Clear and concise verbal and written communication skills.
Strong analytical, problem-solving, and critical thinking skills; ability to act as a change agent.
Project management capabilities and a demonstrated passion for creating new medicines.
GMP compliance & regulatory knowledge for global pharmaceutical manufacturing.
Operational Excellence: Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
Strategic planning, budget & resource management, risk management, and technology/automation familiarity (MES, ERP, etc.).
Compensation & Benefits The anticipated base pay range is
$187,989 - $246,735 USD .
Benefits Legend Biotech offers a comprehensive benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; a 401(k) plan with company match; equity and stock options for eligible roles; paid parental leave; vacation, personal, sick time, holidays, and floating holidays; and additional benefits such as flexible spending accounts, life and disability insurance, and wellness programs.
EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend Biotech maintains a drug-free workplace.
Seniority level
Director
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Biotechnology
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Director of Operations
as part of the
Technical Operations
team based in
Raritan, NJ . This exempt role is responsible for overseeing the production of personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.
Key Responsibilities
Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
Lead a ~250+ organization responsible for either the non-sterile or sterile manufacturing processes in a 24/7 operation and assign personnel to execute daily production schedules.
Direct 3-6 reports ranging from Associate Director, Senior Manager, and Manager.
Oversee hiring, development, and performance management of staff in a growing operation in terms of volume/output and team size.
Manage multiple work centers within the facility to ensure high quality and compliant product supply, overseeing production metrics (employee engagement, safe behavior, quality performance, schedule adherence, and productivity improvements).
Support manufacturing investigations, manage change controls, and maintain inspection readiness; actively support regulatory inspections.
Lead facility operating review meetings and sponsor department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
Support organizational design updates, operations organization build, and ramp-up of commercial and clinical capacity.
Build strong partnerships with Manufacturing, Supply Chain, Engineering, MS&T, and Quality to ensure seamless daily production schedules.
Provide clear leadership to drive effective communication, coordination, and collaboration across cross-functional groups for robust production, testing, and release of product to patients.
Serve as the delegate for the Head of Operations and establish key stakeholder relationships with internal and external partners.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field (required).
Advanced degree (MS, MBA, or PhD) preferred.
Minimally 12+ years of combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation, or quality management; preference for Cell/Gene Therapy experience.
Minimum of 5 years of progressive leadership roles in a cGMP operation, with prior biologics and/or cell therapy operations experience preferred.
Proven ability to lead large, multi-level teams and develop cohesive, high-performing teams with strong succession planning.
Effective communication with people at all levels and the ability to make timely decisions under pressure.
Strong teamwork, interpersonal skills, and ability to influence across levels.
Experience in a growth environment managing fast-paced change, balancing daily operations with long-term planning.
Track record of leading audits and inspections (FDA, EMA, etc.).
Ability to work independently, prioritize, manage multiple tasks, and balance cross-functional issues.
Clear and concise verbal and written communication skills.
Strong analytical, problem-solving, and critical thinking skills; ability to act as a change agent.
Project management capabilities and a demonstrated passion for creating new medicines.
GMP compliance & regulatory knowledge for global pharmaceutical manufacturing.
Operational Excellence: Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
Strategic planning, budget & resource management, risk management, and technology/automation familiarity (MES, ERP, etc.).
Compensation & Benefits The anticipated base pay range is
$187,989 - $246,735 USD .
Benefits Legend Biotech offers a comprehensive benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; a 401(k) plan with company match; equity and stock options for eligible roles; paid parental leave; vacation, personal, sick time, holidays, and floating holidays; and additional benefits such as flexible spending accounts, life and disability insurance, and wellness programs.
EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend Biotech maintains a drug-free workplace.
Seniority level
Director
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Biotechnology
#J-18808-Ljbffr