DIRECTOR/SR DIRECTOR, QUALITY
Company: CARGO-Therapeutics
Location: San Mateo
Posted on: January 22, 2023
Job Description:
POSITION SUMMARYCARGO Therapeutics is hiring a Director/Sr
Director, CMC Quality Assurance within CARGO's technical Operations
team. - -The role will report to the CTO and work closely with
CARGO's executive team, the CMC leadership team, and across the
entire team to develop the Quality function at CARGO.Given that we
are an early-stage company, we expect the Quality function to focus
on the immediate needs to advance the portfolio into the clinic
with a phase appropriate mindset. - Very importantly, this role is
critical to setting the right tone for a strong quality focus and
accountability across the entire company. - We expect the quality
function to grow and evolve as the product and technology portfolio
evolves along with our manufacturing strategy. - The initial scope
of the role will focus on quality oversight of external
manufacturing partners and CDMOs, installation of phase-appropriate
quality systems, supplier audits, and quality oversight of internal
CMC IND enabling activities. - The candidate is expected to play
both in operational hands-on as well strategic capacity while we
build the overall company. - It is an exciting opportunity for a
qualified individual to come in at the ground floor and set the
direction for quality function and overall strategy. -The candidate
will work closely with other leaders in the CMC team (Head of
External Manufacturing, Head of Process Sciences, Head of Gene
Delivery and Editing, Future Head of Manufacturing and Supply
Chain) as well as the CARGO clinical and research teams to ensure
sound quality framework and oversight of our development and
manufacturing operations. - The role is based in San Mateo, CA and
may also be suitable for a hybrid work arrangement.WHAT YOU'LL DO
AT CARGOThe Head of QA is expected to build out the initial Quality
function and strategy and execute against the strategy. -
- The external QA part of the scope of this role will include
quality oversight of 4-6 CDMO partners located in the US and
Europe. - Work at the CDMO includes development of process and
analytical methods, tech transfer in to the CDMOs (and potentially
out back to CARGO or another CDMO in the future) in preparation for
a registration enabling clinical trial for the lead asset.
- Work with external consultants and internal team members to
develop and install a phase appropriate quality system for CARGO's
portfolio, with the initial focus heavily on the lead CD22 asset
headed towards a registration enabling trail.
- Establish systems and procedures for various elements of
quality needed for registration enabling trial including, supplier
audits, lot disposition, deviation management, non-conformance
batches, chain of identify, material and sample handling, lot
testing and release, batch record reviews, tech transfers.
- Ensure timely execution of the above-mentioned applicable
quality procedures for the upcoming work packages related to tech
transfers, GMP supply and batch release.
- Actively participate in the CMC team. - Contribute to the
development and execution of the product strategy.
- Work with internal research counterparts and external academic
partners to ensure appropriate quality oversight of incoming
materials, documents, and data.
- Provide quality oversight of the IND enabling documents
- Conduct audits of the raw material suppliers, CDMOs and other
external partners involved in the entire supply chain for our cell
therapy portfolio.
- Provide quality support to the clinical team in site activation
and apheresis operations.
- Author, review sections of the Module 3 content for IND and
eventually BLA and global regulatory submissions.
- Participate in the manufacturing site inspections of the
external partners, as appropriate and per contract. Ensure
inspection readiness in support of the regulatory submissions.
- Establish appropriate electronic quality systems as the company
scales the operations
- Manage the quality oversight of the GMP training program for
the employees
- Oversee the development and implementation of innovative
systems, tools and streamlined processes to create and maintain
sound and phase appropriate quality system
- Responsible for continuous improvement of quality systems and
processes
- Interface with external quality consultants and eventually hire
additional quality professionals into the teamEXPERIENCE AND
QUALIFICATIONS
- Undergraduate/graduate degree in life science or engineering. -
Graduate degree not required, but preferred.
- Minimum 10-15 years in biotech/pharma industry with 5+ years of
Direct quality functional experience in a technical operations
environment. - Of the total experience, candidate should have 5
plus years of experience managing direct teams. - 3 years of
experience in cell and gene therapy industry is highly desired in
the context of the unique quality systems needed to support
personalized treatments.
- Previous experience with supplier audits, regulatory
inspections, working with CDMOs and setting up scalable quality
systems for early stage growing companies.
- Authoring experience/familiarity with CMC content in regulatory
submissions
- Experience of having worked in cross functional product
development teams
- Knowledge of GMP and quality requirements for cell therapy
products in the context of global approvals
- Ability and interest in rolling up their sleeves to perform
hands-on quality activities while simultaneously building the team
to ensure successful scalability as the company grows
- Demonstrated proficiencies in leading successful health
authority meetings and interactions
- Ability to influence without direct authority
- Independently motivated, excellent in execution, detail
oriented
- Strong written and verbal communication skills, collaboration
skills
- Ability to make timely and sound quality decisions when faced
with complex supply, compliance, technical and regulatory
considerations
- Understanding of the unique aspects cell therapy manufacturing
process and technology
- Proven experience in building a high performing team. You can
recruit and develop top talent, motivate and empower a team, work
cross-functionally, and delegate effectively.
- Must be willing and available for periodic travel (domestic US
and international) as needed.ABOUT CARGO -CARGO Therapeutics,
formerly Syncopation Life Sciences, is advancing a new generation
of adoptive cell therapies for cancers. Our cell therapies focus on
addressing the primary mechanisms of failure, or resistance and
relapse, to the currently available Chimeric Antigen Receptor
T-cell (CAR T) therapies. Despite the advances made by existing
autologous CAR T therapies, these treatments are only curative for
less than half of all cancer patients, and therapeutic failure,
resistance, and relapse are common. In addition, far too many
patients are unable to access these -potentially curative therapies
due to barriers, including manufacturing, supply, -time, -and
reimbursement challenges.CARGO is actively working to address these
barriers with novel solutions that address the problems of
resistance and access. Through smarter science, CARGO is developing
and delivering CAR T-cell therapies to cure more patients. Focused
on the delivery of complex therapeutic cargo, we enable the
-multiplex -engineering necessary to overcome multiple mechanisms
of tumor resistance, to counter inhibition by solid tumors, and in
the allogeneic setting to evade immune rejection. -From research to
manufacturing to clinical care, we at CARGO aspire to disrupt the
status quo to overcome resistance and maximize access to -curative
therapeutics.
Join us to help make a difference.CARGO Therapeutics 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 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, and it applies
regardless of whether the position is located at a CARGO 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/SR DIRECTOR, QUALITY, Executive , San Mateo, California
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