Operations Specialist
Company: Legend Biotech
Location: Raritan
Posted on: March 11, 2026
|
|
|
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 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 an Operations
Specialist as part of the Technical Operations team based in
Raritan, NJ . Role Overview This position will be responsible for
providing operational support to the cGMP Clinical and Commercial
Cell Therapy Manufacturing plant. This individual will partner with
Technical Operations in support of personalized cell therapy
production through safe and compliant manufacturing operations
according to cGMP requirements. The individual will be responsible
for driving and implementing a wide variety of improvements,
ensuring alignment in support of the overall objectives and
priorities of the plant. The role will require communication,
coordination and collaboration across relevant cross functional
groups to enable robust production, testing and release of product
to patients. Key Responsibilities Provides general support to all
Operating Areas, e.g. Manufacturing, Warehouse, Logistics, Support
Labs. Collaborates with Technical Operations who are responsible to
provide process knowledge and expertise in support of GMP
investigations, change controls, document control, process
improvement, process validation and data management. Partners with
Operational Excellence to implement improvements. Writes, reviews,
owns and updates SOPs. Owns, provides assessments and takes actions
in support of change controls. Owns CAPAs and associated project
plans. Supports events such as Root Cause Analysis (RCAs) and
FMEAs. Participates in kaizens and other project initiatives.
Supports any business improvement efforts. Supports permanent
inspection readiness and actively supports internal audits and
regulatory inspections. Provides input to studies related to
process improvement and implementation of new manufacturing
technologies and associated protocols. Provides input and supports
improvements related to the aseptic environment and technique. Job
duties performed routinely require exposure to and handling of
biological materials and hazardous chemicals. Distance visual
acuity of at least 20/40 (Snellen) in both eyes without corrective
lenses or visual acuity corrected to 20/40 (Snellen) or better with
corrective lenses. Color Perception both eyes 5 slides out of 8.
Requirements BS/BA required in technical discipline: Engineering,
science or similar field. GMP Manufacturing, Warehouse and
Logistics experience in the biotech/biopharma industry. Cell/Gene
Therapy cGMP manufacturing experience preferred. Fundamental
understanding of Lean principles and tools, Lean Six Sigma Green
desirable. 3 years of experience leading and/or supporting
improvement or remediation efforts. Strong understanding and proven
application of problem solving tools and techniques. Demonstrated
experience ownings SOPs, change controls, investigations, CAPAs and
other quality system actions. Ability to engage all levels of the
organization, from site leadership to the shop floor. Proven
experience working and leading in a matrix environment. Able to
manage shifting priorities to meet critical deadlines in a fast
paced and dynamic, growing environment. Strong ownership skills and
ability to work independently. Strong analytical, problem solving
and critical thinking skills. Excellent organizational and
communication skills. An ability to build strong partnerships and
effectively integrate with external collaborators to drive
projects/programs forward in a matrixed environment. Ability to
work independently and successfully, prioritize and manage multiple
tasks simultaneously, integrate cross-functional issues and balance
competing priorities effectively. Clear and succinct verbal and
written communication skills with an attention to detail and the
ability to follow procedures. Knowledge of cGMP regulations and FDA
guidance related to manufacturing of cell based products. Physical
dexterity sufficient to use computers and documentation.
Solution-oriented mentality, capable of developing new procedures
and alternate paths to overcome identified opportunities for
improvement. Li-DD1 Li-Onsite The base pay range below is what
Legend Biotech USA Inc. reasonably expects to offer at the time of
posting. Actual compensation may vary based on experience, skills,
qualifications, and geographic location. The company reserves the
right to modify this range as needed and in accordance with
applicable laws. Other Types of Pay: Performance-based bonus and/or
equity is available to employees in eligible roles. Benefits and
Paid Time Off: Medical, dental, and vision insurance as well as a
401(k) retirement plan with a company match that vests fully on day
one. We offer eight (8) weeks of paid parental leave after just
three (3) months of employment, and a paid time off policy that
includes vacation time, personal time, sick time, floating
holidays, and eleven (11) company holidays. Additional voluntary
benefits include flexible spending and health savings accounts,
life and AD&D insurance, short- and long-term disability
coverage, legal assistance, and supplemental plans such as pet,
critical illness, accident, and hospital indemnity insurance. We
also provide voluntary commuter benefits, family planning and care
resources, well-being initiatives, and peer-to-peer recognition
programs; demonstrating our ongoing commitment to building a
culture where our people feel empowered, supported, and inspired to
do their best work. Pay Range (Base Pay): $75,972 - $99,713 USD
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 policy, please
review: Legend Biotech Privacy Policy.
Keywords: Legend Biotech, Reading , Operations Specialist, Manufacturing , Raritan, Pennsylvania