Associate Director / Director, Global Commercial Program Head
Associate Director / Director, Global Commercial Program Head
Legend Biotech
Raritan, NJ
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Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Somerset, New Jersey.
Role Overview
This position is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network. This individual is required to manage a global commercial program to ensure that the process platform is robust and consistent. Strategic planning is required to implement process improvements, optimization, capacity expansion, and cost of goods / non-conformance reduction efforts worldwide.
Key Responsibilities
Legend Biotech maintains a drug-free workplace.
Benefits:
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Somerset, New Jersey.
Role Overview
This position is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network. This individual is required to manage a global commercial program to ensure that the process platform is robust and consistent. Strategic planning is required to implement process improvements, optimization, capacity expansion, and cost of goods / non-conformance reduction efforts worldwide.
Key Responsibilities
- Provide technical leadership and support to an expanding global manufacturing network for best-in-class CAR-T product.
- Work collaboratively with internal and external partners to implement global process improvements/changes to increase robustness, drive down costs, ensure alignment on analytical methods and global records to realize consistent performance worldwide for both Legend and partner sites.
- Provide support during Agency Inspections, filing of Submissions, and IRs.
- Maintain global master batch record and documentation on the platform process and collaborate to the global change control process and global investigations.
- B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
- Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
- Extensive experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.
- Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
- Experience in a cross functional CMC team as a technical representative driving global programs.
- Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits.
- Experience in implementing and managing commercial process improvements and changes.
- Experience in driving consistency across multiple manufacturing sites.
- Experience in Analytical Methods Transfer preferred.
- Experience in managing external partners and CMOs preferred
- Extensive knowledge in process and analytical development, technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics and manufacturing operations support.
- Ability to think critically and demonstrated troubleshooting and problem-solving skills.
- Results driven with strong analytical, problem solving and critical thinking skills.
- Strong experience working in a cross-functional organization with multiple partners with competing priorities.
- Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.
Legend Biotech maintains a drug-free workplace.
Benefits:
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Matched 401K
- Flexible Spending Account
- Health Savings Account
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Paid Maternity Leave
- Paid Paternity Leave
- Pet Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- Legal Insurance
- Commuter Benefits
- Employee Assistance Program
-
Seniority level
Director -
Employment type
Full-time -
Job function
Business Development and Sales -
Industries
Biotechnology Research
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