DIRECTOR OF GENE DELIVERY TECHNICAL DEVELOPMENT
Company: CARGO-Therapeutics
Location: San Mateo
Posted on: March 20, 2023
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Job Description:
POSITION SUMMARY -
Reporting to the CTO, CARGO Therapeutics is hiring a Director of
Gene Delivery Process Development within the Technical Operations
business unit. - This is a leadership role and is being recruited
to establish long term technical development capabilities to
support CARGO's lead asset which is approaching pivotal trial and
the rest of the pipeline. - The initial focus of this role will be
on lentiviral technology platforms, but over time the team will
explore broader gene editing platforms as portfolio evolves. The
leader will recruit a team of technical experts and in-house
development lab to support the needs of the portfolio. The scope of
the role covers the technical development responsibilities for gene
delivery and editing in support of CARGO's entire cell therapy
portfolio as programs advance from pre-clinical to clinical stages.
- The successful candidate will partner closely with Process
Science, Manufacturing, Quality, Regulatory CMC and translational
research teams to select and design the gene delivery tools and
develop process and control system to advance these candidates from
research to clinical and eventually translate to commercial
manufacturing processes.The role is based in San Mateo, CA. This
role may require travel up to 25-35% of the time. -WHAT YOU'LL DO
AT CARGO THERAPEUTICS -Key responsibilities of the Director / Sr
Director of Gene Delivery Technical Development will broadly
include the elements below: - - - - - - Guide the development,
characterization and implementation of the gene editing and
delivery process (internally as well as in partnership with CDMOs);
As such, establish the long-term vision for the Gene Delivery and
Editing CMC function - - - - - - Establish a strong technical team
responsible for developing manufacturing process for the selected
gene delivery platform, which will be focused on lentiviral
platform initially - - - - - - Select and develop analytical
methods, internally and at contract labs, for the characterization
of the vector - - - - - - Develop cost-effective gene delivery
commercial manufacturing process suitable for autologous and
allogenic cell therapy programs - - - - - - Author, review and
approve technical documents that include IND enabling source
documents and regulatory submissions - - - - - - Collaborate across
all CMC functions including Process Science, and QC, Quality,
Manufacturing and CMC Regulatory - - - - - - Develop necessary lab
capability in support of commercial process and analytical
development of viral vectors - - - - - - Tech transfer viral vector
(and other gene delivery platforms in the future) manufacturing
process to CDMOs or from CDMO back for internal manufacturing, if
needed - - - - - - Provide technical oversight to the gene delivery
CDMOs and strategic oversight of the gene delivery topics within
the cross functional CMC teams - - - - - - Interface with external
consultants supporting CARGO on the gene delivery related strategy
topics - -THE RIGHT STUFF: REQUIRED EXPERIENCE & QUALIFICATIONS - -
- - - - - Ph.D. or M.S. in Chemical or Biological Engineering,
Molecular Biology, Genetics, Virology, or related disciplines - - -
- - - 10 plus years of relevant experience, with at least 3 years'
experience directly in cell and gene therapy field - - - - - -
Minimum 3 years of experience leading scientists/engineers; ideally
as a Director - - - - - - Experience developing viral vector
manufacturing process, and evolving processes form research to
clinical manufacturing and commercialization with broad life cycle
management experience. - - - - - - Experience in process and
control system development, authoring technical sections of the
IND, BLA and other regulatory submissions. - - - - - - Experience
tech transferring processes and methods to CDMOs/CMOs and internal
manufacturing sites. - - - - - - Demonstrated technical and people
leadership, ability to influence without direct authority. - - - -
- - Strong problem solving, scientific reasoning skills including
practical experience in implementing meaningful technology
solutions to simplify cell therapy manufacturing. - - - - - -
Ability to effectively communicate complex technical content to a
range of audience in oral and written formats. - - - - - -
Demonstrated evidence for problem solving, logical scientific
reasoning, practical approach to implementing technology solutions
to ultimately establish a reliable and robust manufacturing and
supply network. - - - - - - Knowledge of basic GMPs and regulatory
requirements applicable to cell and gene therapy. - - - - - -
Ability and willingness to roll up the sleeves and be hands-on and
flexible while we are building the team. - - - - - - Experience in
working with cross functional product teams. - - - - - - Proven
record of being able to hire top technical talent. - - - - - -
Experience leading small teams comprised of technical experts
-PREFERRED EXPERIENCE & QUALIFICATIONS - - - - - - - Experience
working with viral vector and cell therapy processes - - - - - - -
Experience working external CDMO relationships as well as working
in internal manufacturing operation -PAY RANGEThe combined pay
range for this role is from $178,608 to $270,972. Title and salary
will be based on our assessment of how relevant candidate's skills
and experience are to our job requirements. -ABOUT CARGO
THERAPEUTICS -CARGO Therapeutics is engineering best-in-class CAR
T-cell therapy to overcome resistance to cancer treatment and
address barriers to access so that more patients may benefit from
potentially curative therapies. CARGO is on a mission to outsmart
cancer by advancing a new generation of best-in-class chimeric
antigen receptor (CAR) T-cell therapies. Despite advances made by
commercially available autologous CARs, these treatments are
curative for fewer than half of all cancer patients. In addition,
far too many patients are unable to access these potentially
curative therapies due to other challenges, including
manufacturing, supply constraints, slow turnaround time and
reimbursement hurdles. The team at CARGO is intensely focused on
pursuing novel solutions to achieve better cancer treatment
outcomes and experiences. ---Our founders are pioneers and world
experts in CAR T cell therapy, and we have built a team with
experience and success developing, manufacturing, launching and
commercializing oncology and cell therapy products. CARGO
Therapeutics colleagues share a passion to help others thrive.---
We are tenacious in the relentless pursuit of our mission, and we
innovate to change the game for the patients we serve. - -Join us
to help make a difference! - -EEO & EMPLOYMENT ELIGIBILITY - -CARGO
Therapeutics, Inc. is committed to building a diverse, equitable,
and inclusive company. We provide equal opportunity in the terms
and conditions of employment for all employees and job applicants
without regard to race, color, religion, sex, sexual orientation,
age, gender identity or gender expression, national origin,
disability, or veteran status. CARGO Therapeutics, Inc. also
complies with all applicable national, state, and local laws
governing nondiscrimination in employment as well as work
authorization and employment eligibility verification requires of
applicable law. - -CARGO Therapeutics requires all new hires to be
fully vaccinated against COVID-19 as of their start date.--- This
requirement is a condition of employment at CARGO Therapeutics, and
it applies regardless of whether the position is located at a CARGO
Therapeutics site or is fully remote.--- If you are unable to
receive the vaccine due to a disability or serious medical
condition, or because it is prohibited because of your sincerely
held religious beliefs, you will have an opportunity to request a
reasonable accommodation. -
Keywords: CARGO-Therapeutics, San Mateo , DIRECTOR OF GENE DELIVERY TECHNICAL DEVELOPMENT, Executive , San Mateo, California
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