Scientist II/Senior Scientist CMO MSAT
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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
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). 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 a Scientist II/Senior Scientist CMO MSAT as part of the External Manufacturing team based in Raritan, NJ.
Role Overview
The position will be part of the CMO MSAT team driving the capacity ramp-up and supporting commercial manufacture of Carvykti at our external manufacture partners. He/she is part of an integrated virtual management team, working with our partner JNJ, to oversee the technical side of the CMO operation.
Key Responsibilities
- Oversee and support CMO technical operations and routine manufacturing: including deviation investigations, change controls, process improvements and continuous process validation.
- Serve as a technical Person-In-Plant (PIP) for commercial batches, including off-hours or weekend coverage when required.
- Represent MSAT in internal and external cross-functional meetings, providing timely and structured updates on project status, technical risks and mitigation strategies.
- Partner with Data Scientists to support monitoring manufacturing performance, identify and investigate out-of-trend critical process parameters (CPPs) in-process testing and critical quality attributes (CQAs).
- Collaborate with the global MSAT team to implement change controls and drive process improvement initiatives.
Requirements
- BS/MS in a related technical discipline (Engineering, Biological Sciences, Pharmaceutical Sciences, etc.) with 5 years of experience in the industry or 3 years’ experience in cell therapy.
- CAR-T manufacturing and CMO oversight experience strongly preferred.
- Strong understanding of GMPs, deviation and change control management, CPV, tech transfer and authoring technical documentation.
- Proven analytical, problem-solving and critical thinking skills with a results driven mindset.
- Ability to excel in a fast-paced, dynamic environment while managing multiple priorities.
- Excellent time management, organizational and communication skills.
- Experience supporting virtual or external manufacturing environments preferred.
#Li-RP1
#Li-Onsite
Please note: 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 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.