Sr. Advanced Specialist Clinical Manufacturing Operations and Sciences, Viral Vector
Company: Legend Biotech
Location: Somerset
Posted on: January 22, 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 Sr. Advanced
Specialist Clinical Manufacturing Operations and Sciences, Viral
Vector as part of the Technical Development team based in Somerset,
NJ . Role Overview The Sr. Advanced Specialist Clinical
Manufacturing Operations and Sciences, Viral Vector will be
responsible for providing technical strategies and performing
related activities necessary to start up and perform routine
operations within a new in-house GMP facility and delivering Phase
1 clinical trial material for several viral vector pipeline assets
to patients in need. The successful candidate will collaborate with
a cross-functional team including quality, IT, facilities, safety,
and operations to establish the systems necessary to operate a GMP
manufacturing facility for the purpose of producing Phase 1
products. The following activities will include tech transfer, data
analysis, troubleshooting and executing manufacturing viral vector
product candidates within the facility. Key Responsibilities Create
and author manufacturing procedures necessary to operate a viral
vector suite within a GMP manufacturing facility at Phase 1
clinical standards. Author facility risk and gap assessments for
implementation of GMP viral vector manufacturing. Collaborate with
Technical Development teams to identify GMP viral vector
manufacturing equipment. Act as the primary manufacturing point of
contact for study, and clinical manufacturing execution escalations
for multiple viral vector GMP processes. Provide manufacturing
oversight, training, and support within the manufacturing cleanroom
environment. Drive Technology Transfer campaigns of new product
introduction and process improvements to internal programs. Provide
hands-on manufacturing training as needed. Translate process
development reports into manufacturing batch records and SOPs as
part of tech transfer. Analyze and interpret manufacturing process
data. Perform complex manufacturing investigations including OOS,
OOT, and deviations. Author and review investigation reports,
CAPAs, and change controls. Review and resolve corrections in
executed batch records. Review executed batch records and assist
with corrections as required. Drive continuous improvement
initiatives. Represent viral vector manufacturing operations as
technical SME in cross-functional meetings and project teams,
providing subject matter expertise minimally on manufacturing
operations, execution trends, and manufacturing requirements.
Coordinate with QC to transfer samples for testing and support the
investigate out-of-specification results collaboratively. Author
and lead execution of tech transfer protocols. Foster a culture of
quality and compliance. Requirements BS in cell biology, molecular
biology, immunology, microbiology, biomedical engineering or other
related sciences preferred. 5 years of experience in viral vector
GMP manufacturing including operations, supervision, tech transfer,
and strategy setting. Knowledge and experience with viral vector
manufacturing and tech transfer. Experience establishing and
operating in a GMP environment. Experience and knowledge of viral
vector manufacturing equipment. Pragmatism in applying GMP in a
phase-specific manner in the best interest of the patient.
Experience working in cross-functional matrices. Excellent
collaboration skills. Ability to manage shifting priorities to meet
critical deadlines in a fast-paced and dynamic, growing
environment. Expertise with aseptic processing. Patient focus is a
must. Li-JR1 Li-Hybrid 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. Performance-based bonus and/or equity is available
to employees in eligible roles. The anticipated base pay range is:
$107,482 - $141,070 USD Benefits Benefits include 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 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 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. Please note: These benefits are
offered exclusively to permanent full-time employees. Contract
employees 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.
Legend may adjust base salary or other discretionary compensation
at any time based on individual, team, performance, or market
conditions. Legend Biotech maintains a drug-free workplace.
Keywords: Legend Biotech, Hoboken , Sr. Advanced Specialist Clinical Manufacturing Operations and Sciences, Viral Vector, Healthcare , Somerset, New Jersey
