PROCESS DEVELOPMENT ENGINEER/SR. ENGINEER *

Company: CARGO-Therapeutics
Location: San Mateo
Posted on: March 10, 2023

Job Description:

POSITION SUMMARY -Reporting to a lead within the Process Sciences team, CARGO is hiring a Process Development Engineer/Sr. Engineer* within the Process Sciences Organization in Technical Operations at Cargo Therapeutics. The candidate will contribute to and support development of GMP compatible manufacturing processes for production of CARGO's cell therapy products. The ideal candidate will have a background in cell selection, lentiviral transduction, cell culture and expansion, and flow cytometry analysis. The successful candidate will work closely with the Process Sciences team and the broader CMC team. The individual will also collaborate cross-functionally to ensure timely development and manufacture, and release of drug products as well as support regulatory submissions. The position is lab-facing and based in our San Mateo office. - -WHAT YOU WILL DO AT CARGO THERAPEUTICS - -Key responsibilities of the Process Development Engineer/Sr. Engineer/Principal Engineer are summarized below, and these will evolve over time as the portfolio matures.

• Support planning and execution of experiments and associated analysis and reporting
• Provide process development support in team-based environment for technical development studies performed both internally and externally
• Support technology transfer to partners at external contract manufacturing organization including compilation of documentation (protocols, test methods, reports)
• Participate in laboratory set up, equipment procurement, and establish internal process development practices
• Author relevant documentation (protocols, technical development, qualification reports)
• Organize, communicate, and present data to key stakeholders, senior management, and external partners
• Interface and work collaboratively with CDMO and testing lab partners
• Proactively enable cross-functional collaborations with internal stakeholders, external partners, and consultants.
• 2+ years of relevant experience in T cell biology and/or immunotherapy -
• In-depth knowledge with cell selection, lentiviral transduction, cell culture and expansion, and flow cytometry analysis -
• Success authoring relevant documentation such as protocols, technical development, and qualification reports - - - - - - -THE RIGHT STUFF: REQUIRED EXPERIENCE AND QUALIFICATIONS - -
  • Bachelors or Master's degree in a relevant scientific area such as biotechnology, bioprocess, molecular biology, immunology, biochemistry
  • BS/MS with 2 years' experience for Engineer or BS/MS with 5+ year industry experience or PhD -for Sr. Engineer*
  • Experience successfully managing tech transfer to external contract manufacturing organizations
  • History of working with CDMO and testing lab partners
  • Proficiency in Microsoft Office suite
  • Flexibility with work schedule/on-site availability (i.e., occasional weekend work) as we are building the team -
  • Success working in a highly adaptive environment and learn new skills for changing priorities -
  • History of successfully working in a highly adaptive environment and learning new skills for changing priorities
  • Flexible and creative, with ability to think outside the box
  • Strong interpersonal, organizational, written, and verbal communication skills -
  • Success working work collaboratively in a team environment
  • Willingness to travel up to 10-20% of the time -PREFERRED EXPERIENCE & QUALIFICATIONS -
    • Prior experience in late-stage cell therapy, industry process development -
    • Expertise in human immune cell isolation, T cell expansion, and mammalian cell culture techniques -
    • Experience with scale-down models (i.e., mini bioreactors) for small-scale screening of media formulations, novel reagents, etc. -
    • Experience with scale-up expansion cultures in bioreactors, working with closed fluidic systems, monitoring of in-process parameters (i.e. metabolites, gas exchange) -
    • Experience with Design of Experiment (DoE) and Failure Mode & Effects Analysis (FMEA) based approaches -
    • Experience with quality and regulatory based guidelines for late-state cell therapies -
    • Experience with virus-based gene modification is preferred, and non-viral based methods -
    • Experience with late-stage process characterization and validation work -
    • Experience with other novel cell therapy platforms beyond commonly used technologies in the current field -
    • Experience with multi-color flow cytometry -
    • Experience with electronic lab notebooks and inventory system -
    • Proficiency in Office, Design of Experiments, JMP, Prism, and other productivity and data analysis tools -PAY RANGEThe combined pay range for Process Development Engineer/Sr. Engineer is from $130,448 to $170,874. *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, formerly Syncopation Life Sciences, is advancing a new generation of adoptive cell therapies for cancers. Our lead program is addressing a primary mechanism of resistance and relapse to the currently available Chimeric Antigen Receptor T-cell (CAR T) therapies. Despite advances made by commercially available autologous CARs, these treatments are only curative for less 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, time, and reimbursement. CARGO is actively working on novel solutions to achieve better outcomes and experiences. Our mission is to outsmart cancer and develop the next generation of best-in-class CARs. Beyond our lead program, our platform technologies 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. - -We have the capability to incorporate complex therapeutic cargo into our CARs, with the potential to achieve durable responses that are curative for more patients. - -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 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 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 requirements 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 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 , PROCESS DEVELOPMENT ENGINEER/SR. ENGINEER *, Engineering , San Mateo, California