Manufacturing Lead Operator
Company: Legend Biotech
Location: Raritan
Posted on: March 5, 2026
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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 a Manufacturing Lead
Operator as part of the Technical Operations team based in Raritan,
NJ. Role Overview CAR-T products and processes are a novel cell
therapy, and thus are well supported by a degree in engineering or
a related field where not only are valuable scientific and
technical skills learned, but also the ability to connect ideas and
analyze complex problems. This role will be part of the Technical
Operations team responsible for the production of a personalized
cell therapy to support both clinical and commercial requirements
in a sterile cGMP environment. Job duties will be performed within
a team based on an assigned production shift schedule. Key
Responsibilities Establishes effective time management skills and
prioritization of various job requirements, supported by a degree
in engineering or related field to better analyze and execute
effective decision during critical times for positive outcomes. To
offer support in development of CAR-T manufacturing processes, this
individual requires an understanding of the underlying technical
requirements of the process and product must have, where complex
risk analyses and change management techniques are utilized to
establish a high quality and safe drug product through periods of
improvement. This individual with strong scientific and technical
background, will support the development of manufacturing
processes, and will work with technical support and engineering
personnel to drive continuous improvements and implement corrective
and preventative actions within cell therapy Technical Operations.
Responsible for general production floor oversight of Legend
Biotech's BCMA CAR-T Cell Therapy Operations in both ISO 5 and ISO
7 environments, and support floor activities with extensive
knowledge of CAR-T cell therapy processes, GMP quality systems and
their regulatory requirements. Requires prior in-depth knowledge of
lab sciences, cellular lab techniques, and data analysis to
complete daily responsibilities and assess the impacts and
consequences in relation to other process areas, without
jeopardizing quality, accuracy and efficiency. Perform process unit
operations (i.e. cell culture, purification, aseptic processing,
and cryopreservation) performed within specialized BSL2 ISO 5 and
ISO 7 cleanroom environments, according to standard operating
procedures and batch records, while recording production data and
information in a clear, concise format. Requires critical thinking
and troubleshooting skills to respond to patient specific product
issues to ensure continuous flow of operations, while performing
tasks on time in a manner consistent with safety policies, quality
systems, and cGMP requirements within particular manufacturing
processes. Establish key stakeholder relationships with internal
and external stakeholders, as collaboration and understanding
across functional stakeholders are essential to maintaining this
dynamic, fast-paced environment, which is CAR-T manufacturing With
a degree in engineering and related scientific or technical field,
this individual must have the ability to interact with all levels
within the organization through scientific and technical expertise
Strong communicative skills and a broad technical understanding of
complex systems are must haves, to build strong partnerships with
Manufacturing, Engineering, and Quality, and work as part of a
cross-functional and matrixed team to successful manufacture CAR-T
product in a safe and high quality manner. Requirements Bachelor’s
degree in life science/engineering, or related field or equivalent
experience required. A minimum of 2 years of operations experience
within a cGMP environment in the biotech/biopharma industry. Prior
experience in manufacturing, maintenance, quality, testing, or
engineering is required. Prior experience in an aseptic
manufacturing environment is preferred. 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. Ability to lift a minimum of 50 lbs and stand for a long
period of time. Sufficient vision and hearing capability to work in
job environment with physical dexterity sufficient to use computers
and document production records. Ability to handle human derived
materials in BSL-2 cleanroom facility. Physical dexterity
sufficient to use computers and documentation. Ability to
accommodate shift work including evenings and weekends as required
by the manufacturing process. Ability to accommodate unplanned
overtime on little to no prior notice. 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. Li-RN1 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, Vineland , Manufacturing Lead Operator, Engineering , Raritan, New Jersey