United States - California - Santa Monica
Kite is continuing to hire for all open roles. Our interview
process may be conducted virtually and some roles will be asked to
temporarily work from home. Over the coming weeks and months, we
will be implementing a phased approach to bringing employees back
to site to ensure the health and safety of our teams.
For Current Kite Pharma Employees and Contractors: Everyone at
Kite is grounded by one common goal – curing cancer. Every single
day, we seek to establish a direct line between that purpose and
our day-to-day work. Join us in our mission!
We are seeking a Commercial Product Quality Leader for Kite’s
commercial products. You will provide technical expertise and
leadership to Product CMC/Quality Teams to develop, implement, and
manage the strategies for Quality to meet late-stage and commercial
product goals. As a product expert in Quality, this role has the
responsibility for technical expertise and project support for the
Quality and Compliance aspects of the product throughout its life
cycle (i.e., life cycle management). You will help to define the
operational Quality and Compliance strategy with the Commercial
Product Quality Director and will be active in the execution of the
strategies supporting the commercial Operations Team.
As a product expert in Quality, the Commercial Product Quality
Leader role has responsibility for working directly with Operations
Leaders, Quality Control (QC), Regulatory Affairs, Process
Development (PD), Quality Assurance (QA), Qualified Persons, and
Manufacturing on the resolution of issues and implementation of
strategies associated with cell therapy products. This includes
topics related to technology transfers, manufacturing process
improvements, in-process control and critical quality attribute
trends, analytical methods (transfers, validation, performance and
improvements), product and starting material specifications,
reference standards, importation testing, investigations, change
controls, regulatory submissions, annual product reviews, risk
assessments and regulatory inspections related to product(s). Your
work will drive initiatives intended to ensure the overall
Other responsibilities include (but are not limited to):
Provide quality leadership on cross-functional teams in a matrix
environment, driving alignment and decision making, performing a
scientifically sound and risk-based evaluation of process and
product quality data, and developing patient-oriented
Execute/drive product strategies under the direction of the
Director, Product Quality through strong quality and scientific
leadership related to technology transfers, global regulatory
filing strategies, analytical method improvements, stability,
product specifications and program improvements.
Support operationalizing theoretical concepts (e.g. product
strategies) into actionable plans and execute those plans with
Negotiate plans with regulatory authorities and internal
multi-functional teams to obtain the optimal product quality
position for life cycle management
Actively participate in the global Commercial Product Quality
Team. Act as delegate to Commercial Product Quality Director for
the Product Quality Team, as needed.
Author sections of regulatory submissions, as directed
Help develop the Stability strategy of the Product
Monitor Product Quality Data
Lead authorship of the Annual Product Review, as assigned, for
commercial marketed products
PhD/MS in biochemistry, biology, regulatory sciences,
engineering or a related protein/biotechnology sciences field and
minimum 3+ years of directly related experience in
late-stage/commercial biologic products OR Bachelor’s degree in
biochemistry, biology, engineering or a related
protein/biotechnology sciences field and 8+ years of directly
related experience in late-stage/commercial biologics
3+ years working in a regulated environment (either direct GMP
or technical support)
Experience with authoring or review of biological license
applications/MAAs, INDs/IMPDs, supplements/variations or similar
regulatory documentation (i.e. review cycle questions), highly
Experience supporting non-conformance investigations, authoring,
reviewing and defending critical product impacting
Communicate complex ideas succinctly and clearly, both verbally
and in writing, to a variety of audiences.
Excellent written and verbal communication skills, including
facilitation and presentation skills.
Ability to influence others through persuasive interactions and
garner support for novel solutions where applicable.
Ability to work and navigate within an evolving scientific and
Familiarity with compliance and regulatory requirements of the
FDA as well as international regulatory agencies in international
expansion regions, preferred.
Experience in direct interaction with regulatory agencies/Boards
of Health during inspections
Understanding of biologic product development and manufacturing
Knowledge of cGMP and filing regulations, guidelines, practices,
and trends pertaining to the manufacture and testing of
biopharmaceuticals is preferred.
Previous experience working on a cross-functional team in a
matrix environment is a plus.
Kite is a biopharmaceutical company engaged in the development
of innovative cancer immunotherapies with a goal of providing
rapid, long-term durable response and eliminating the burden of
chronic care. The company is focused on chimeric antigen receptor
(CAR) and T cell receptor (TCR) engineered cell therapies designed
to empower the immune system's ability to recognize and kill
tumors. Kite is based in Santa Monica, CA. For more information on
Kite, please visit www.kitepharma.com . Sign up to follow
@KitePharma on Twitter at www.twitter.com/kitepharma .
For jobs in the United States: As an equal opportunity employer,
Gilead Sciences Inc. is committed to a diverse workforce.
Employment decisions regarding recruitment and selection will be
made without discrimination based on race, color, religion,
national origin, gender, age, sexual orientation, physical or
mental disability, genetic information or characteristic,
gender identity and expression, veteran status, or other non-job
related characteristics or other prohibited grounds specified in
applicable federal, state and local laws. In order to ensure
reasonable accommodation for individuals protected by Section 503
of the Rehabilitation Act of 1973, the Vietnam Era Veterans'
Readjustment Act of 1974, and Title I of the Americans with
Disabilities Act of 1990, applicants who require accommodation in
the job application process may contact
firstname.lastname@example.org for assistance.
For more information about equal employment opportunity
protections, please view the ‘EEO is the Law’
Our environment respects individual differences and recognizes
each employee as an integral member of our company. Our workforce
reflects these values and celebrates the individuals who make up
our growing team.
Gilead provides a work environment free of harassment and
prohibited conduct. We promote and support individual differences
and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors: Gilead
Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercialises innovative medicines in
areas of unmet medical need. With each new discovery and
investigational drug candidate, we seek to improve the care of
patients living with life-threatening diseases around the world.
Gilead’s therapeutic areas of focus include HIV/AIDS, liver
diseases, cancer and inflammation, and serious respiratory and
If this is not the right move for you now but remain interested
in a career at Gilead Sciences please connect with us via our
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