Senior Director, Process Development

San Carlos, CA, United States

Description

The Senior Director of Process Development is responsible for managing the high performing organization, people, processes, procedures, business strategies, and the overall continuous building of a proficient Process Development department. The successful candidate will have technical expertise in cellular therapy and gene editing technologies, as well as leadership skills to manage a team of scientists and engineers. They will oversee the development, optimization, and scale-up of processes for the production of engineered T-cells, and will work collaboratively with cross-functional teams to ensure the successful implementation of these processes in a GMP environment. Per the integrated CMC strategy, the candidate will represent Process Development in support of regulatory filing, clinical manufacturing, raw materials and logistics, and interface with ClinOps for drug product administration conditions.

The role is based in San Carlos, CA.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

Drive Process Development group goals and assist in managing project plans, timelines, and budgets

Establish the strategy and infrastructure for developing novel production processes for candidate engineered T-cell therapeutics, ultimately leading to GMP-compliant manufacturing processes for early and late phase clinical trials

Assist in managing the translation of Research & Development programs to GMP manufacturing

Promote the CMC strategy, along with other Tech Ops functions

Participate in Regulatory authority interactions

Drive the implementation of innovative, next generation cell processing technology for manufacture of cell therapies

Provide guidance for Technical Operations team

Represent the Process Development functions in cross-functional team forums

Periodically assess with customers that expected service level is being attained, and strive to exceed expectations

Build and develop an inclusive high performing team, and develop the next generation of leaders by creating an inclusive culture to ensure effective personal development of leaders

Build and sustain strong relationships with internal and external stakeholders to meet business requirements

Contribute to strategy and authoring regulatory filings

Support clinical manufacturing by defining process control parameters and providing subject matter expertise for deviation management and change controls

Facilitate risk management for process risks, operational risks, and raw material risks with respect to product quality attributes

Coordinate single-use raw materials extractables/leachables testing as well as final product container closure integrity testing

Support Supply Chain and MSAT with labeling qualification, packaging, and shipping qualification

THE RIGHT STUFF: Required Experience & Qualifications BS/BA in Biomedical Sciences, Bioengineering, or related field with 12+ years' experience, or MS/MA with 8+ years, or PhD with 4+ years of experience

Experience with different modalities of genetically modified cell therapies (e.g. CAR T, TCR, HSCs, CD34+, etc.)

Experience in developing and implementing cell therapy manufacturing processes and systems

Experience with manufacturing genetically modified cell therapy products, ideally both in industry and academia

Experience in tech transfer and process characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment

Knowledge across various manufacturing technologies used for cell and gene therapy including viral and non-viral genome engineering technologies

Experience with both autologous and allogeneic cell therapy manufacturing workflows is desirable

Excellent data analysis skills and experience with a variety of scientific software applications

Proficient experimental design and troubleshooting skills, with the ability to document laboratory procedures and experiments with great attention to detail

Demonstrated leadership and people management capabilities in driving change in complex, matrixed environments; can drive appropriate dialogue at the senior level to escalate and resolve issues; executive presence

Exceptional talent builder and team leader; actively sought out by others as a coach and mentor

Excellent verbal and written communication skills with the ability to interpret, summarize, and present scientific results in a concise manner to both technical and non-technical audiences

Ability to distill complex information and tailor verbal and written communications in a concise, logical, and audience appropriate manner

Self-motivated and willing to accept responsibilities outside of initial job description

Self-awareness, integrity, authenticity, and a growth mindset

PAY RANGE

The pay range for this role is $200,000 - $275,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

ABOUT CARGO THERAPEUTICS

CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.

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 required 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.