Manager, Operations Training
Legend Biotech
4 hours ago
On-site
Raritan, NJ
Operations
Role Overview
- Manage the operations training team supporting cGMP Commercial Cell Therapy Manufacturing plant personnel.
- Oversee training to enable safe, compliant, personalized cell therapy production per cGMP requirements.
- Support the door-to-floor program and ramp-up of commercial production.
Key Responsibilities
- Lead, direct, coach, and develop a holistic training program for all plant functions/personnel supporting daily commercial production.
- Manage the 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.
- Manage training requirements for new hires.
- Collaborate with functional leads for procedure alignment based on roles.
- Serve as subject matter expert for Compliance & Training systems.
- Oversee onboarding for new manufacturing operators.
- Maintain working knowledge of the LMS.
- Maintain and report quality training metrics.
- Prepare information for internal and external audits.
- Ensure productivity, timeliness, and quality of Change Controls and CAPA implementation.
Requirements
- Bachelor’s degree in Science (advanced degree preferred).
- 5–8 years relevant work and management experience; preferred experience in aseptic manufacturing and training/system applications, quality systems, or learning management systems.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing; Good Tissue Practices.
- Ability to manage shifting priorities and meet critical deadlines; provide clear direction.
- Strong analytical, problem-solving, and critical thinking skills; lead as a change agent.
- Ability to prioritize and execute in a fast-paced environment.
- Team-oriented, collaborative; track record of continuous improvement.
- Proven leadership and team management skills.
Benefits
- Medical, dental, vision; 401(k) with company match (vests fully day one).
- 8 weeks paid parental leave after 3 months.
- Paid time off: vacation, personal, sick, floating holidays, 11 company holidays.
- Additional voluntary benefits: flexible spending/HSAs, life & AD&D, short-/long-term disability, legal assistance, supplemental plans (e.g., pet/critical illness/accident/hospital indemnity).
- Voluntary commuter benefits, family planning/care resources, well-being initiatives, peer-to-peer recognition.
- Pay range (base): $123,605–$162,232 USD.
- Manage the operations training team supporting cGMP Commercial Cell Therapy Manufacturing plant personnel.
- Oversee training to enable safe, compliant, personalized cell therapy production per cGMP requirements.
- Support the door-to-floor program and ramp-up of commercial production.
Key Responsibilities
- Lead, direct, coach, and develop a holistic training program for all plant functions/personnel supporting daily commercial production.
- Manage the 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.
- Manage training requirements for new hires.
- Collaborate with functional leads for procedure alignment based on roles.
- Serve as subject matter expert for Compliance & Training systems.
- Oversee onboarding for new manufacturing operators.
- Maintain working knowledge of the LMS.
- Maintain and report quality training metrics.
- Prepare information for internal and external audits.
- Ensure productivity, timeliness, and quality of Change Controls and CAPA implementation.
Requirements
- Bachelor’s degree in Science (advanced degree preferred).
- 5–8 years relevant work and management experience; preferred experience in aseptic manufacturing and training/system applications, quality systems, or learning management systems.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing; Good Tissue Practices.
- Ability to manage shifting priorities and meet critical deadlines; provide clear direction.
- Strong analytical, problem-solving, and critical thinking skills; lead as a change agent.
- Ability to prioritize and execute in a fast-paced environment.
- Team-oriented, collaborative; track record of continuous improvement.
- Proven leadership and team management skills.
Benefits
- Medical, dental, vision; 401(k) with company match (vests fully day one).
- 8 weeks paid parental leave after 3 months.
- Paid time off: vacation, personal, sick, floating holidays, 11 company holidays.
- Additional voluntary benefits: flexible spending/HSAs, life & AD&D, short-/long-term disability, legal assistance, supplemental plans (e.g., pet/critical illness/accident/hospital indemnity).
- Voluntary commuter benefits, family planning/care resources, well-being initiatives, peer-to-peer recognition.
- Pay range (base): $123,605–$162,232 USD.