Associate Manager, QC
Company: Legend Biotech
Location: Raritan
Posted on: January 9, 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 Associate Manager,
QC as part of the Quality team based in Raritan, NJ . Role Overview
The QC Associate Manager is an exempt level position with
responsibilities for managing the operation and workflow of the
quality control laboratories in support of cell therapy
manufacturing. This includes hiring, development and performance
management of staff, reviewing/approving laboratory test data and
methods, supporting laboratory investigations and ownership of
various QC department projects. Key Responsibilities Ensuring
adequate training (skills-based, cGMP and safety) of associates
within the department Oversight of raw material, in-process,
environmental/utility, product release, and stability testing,
investigation of laboratory non-conformances (events, deviations,
and invalid assays), and maintenance, calibration and qualification
of laboratory instruments and equipment. Support test method
verification, qualification, validation and/or transfer activities
in the QC laboratories in conjunction with QC Management and QA
Validation/Equipment groups. Providing expertise in troubleshooting
complex laboratory issues and demonstrating strong reasoning skills
in support of ongoing laboratory investigations. Make quick,
informed decisions with minimal to no supervision during 2nd shift
hours. Maintain detailed knowledge of industry guidelines/trends,
regulatory requirements, and applicable pharmacopeia while
remaining current in on-the-job training requirements. Collaborate
with Quality Assurance, Manufacturing, Technical Operations,
Engineering and Maintenance to support business needs. Perform
tasks in a manner consistent with the safety policies, quality
systems and cGMP requirements. Other duties will be assigned, as
necessary. Authority to make decisions related to day-to-day
processing of batches in the QC laboratory. Decisions must be made
in conjunction with the Quality Assurance team if an issue is not
addressed by any Legend Biotech Standard Operating Procedure.
Decisions related to project execution, including timelines,
milestones and resource allocation within budget can be made in
collaboration with QC Leadership. Higher-level approvals are
required for those related to significant budget allocations,
strategic shifts, or major collaborations that have substantial
financial or long-term implications. Requirements A minimum of a
Bachelor’s Degree in Science, Engineering or equivalent technical
discipline is required. A minimum of 8 to 10 years of relevant work
experience is required. It is preferable that the candidate has
experience working in an aseptic manufacturing facility, preferably
in quality control, quality assurance, or cell therapy. A minimum
of 2 to 4 years of direct people leadership experience is REQUIRED.
Required shift hours will be Monday-Friday, 5PM-1:30AM Experience
in clinical quality, method development, cell banking, cell
therapy, or Research & Development is preferred. People management
or leadership experience is required. Experience working with
Quality systems is required. Experience with quality support in
clinical manufacturing or NPI is preferred. Extensive knowledge of
chemical, biochemical and microbiological concepts is required.
Ability to apply basic and advanced mathematical concepts
(including statistics) in the evaluation of laboratory data is
required. Knowledge of cGMP regulations and FDA/EU guidance is
required. The candidate must be highly organized and capable of
working in a team environment with a positive attitude under
minimal to no supervision. Comfortable with speaking to and
interacting with inspectors and supporting additional regulatory
audit activities as needed. Good written and verbal communication
skills are required. Candidates must be able to accommodate
unplanned overtime (including nights and weekends) on little to no
prior notice. Li-RP1 Li-Onsite The anticipated base pay range is
$93,463 - $122,670 USD Benefits We are committed to creating a
workplace where employees can thrive - both professionally and
personally. To attract and retain top talent in a highly
competitive industry, we offer a best-in-class benefits package
that supports well-being, financial stability, and long-term career
growth. Our offerings are designed to meet the diverse needs of our
team members and their families, ensuring they feel valued and
supported every step of the way. Highlights include medical,
dental, and vision insurance as well as a 401(k)-retirement plan
with company match that vest fully on day one. Equity and stock
options are available to employees in eligible roles. We offer
eight weeks of paid parental leave after just three months of
employment, and a paid time off policy that includes vacation days,
personal days, sick time, 11 company holidays, and 3 floating
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 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, Philadelphia , Associate Manager, QC, Science, Research & Development , Raritan, Pennsylvania