Senior Scientist, Process Development (I,II,III)

@ Cellares
Cellarescellares.com

Senior Scientist, Process Development (I,II,III)

Posted 4 months ago

This job is still taking applications, but it's been up a while.

About the job

Cellares develops advanced cell therapy manufacturing platforms using Industry 4.0 technologies. The role involves designing, executing experiments, and collaborating across teams to improve cell therapy processes, supporting global access to cell-based medicines.

Requirements

  • Process development experience in cell and gene therapy
  • Experience with cell processing instruments
  • Knowledge of cell editing technologies
  • Strong communication skills
  • Cross-functional collaboration skills

Qualifications

  • Bachelor's, Master's, or PhD in bioengineering or related
  • 6-21 years of relevant experience
  • Expertise in T cell or immune cell therapy
  • Familiar with cGMP regulations

Full job description

Position Summary

Cellares is seeking an innovative and highly motivated Senior Scientist with expertise in cell therapy manufacturing to join the Process Development team. This individual will interface across many parts of the company and contribute significantly to the development of our advanced cell therapy manufacturing platform.  

The primary focus of this position is to design, coordinate, execute and analyze cell therapy process development experiments that expand and drive continuous improvement of the Cellares platform. The ideal candidate will be a highly organized technical leader and cross-functional collaborator with demonstrated expertise in developing robust autologous and allogeneic cell therapy processes.

Candidates should also enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

  • Design and execute complex experiments using scientific principles and statistical approaches (DOE) to support the development of the Cellares platform
  • Interface internally and cross-functionally with Analytical Development, MSAT, Quality, Manufacturing, BD, Product, and Engineering to implement new processes and technologies as part of the core technology transfer team
  • Author and review technical documents, procedures and reports to ensure accuracy and quality
  • Present technical and programmatic information to internal and client-facing stakeholders
  • Coordinate day-to-day team efforts and provide technical training and guidance to junior team members
  • Develop training materials for scientific methods and techniques, train and onboard new hires
  • Serve as subject matter expert where appropriate for the cell and gene therapy process, provide technical insights and support in troubleshooting and root cause investigations

Requirements

  • Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-21 years of process development experience in the cell and gene therapy field
  • Subject-matter expert in T cell, HSC, or other immune cell therapy modality
  • Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave) relevant to cell selection/purification and expansion
  • Familiarity with diverse cell editing technologies (LVV, RVV, LNP) and processes (transduction, transfection, electroporation, etc.) 
  • Excellent verbal and written communication skills; able to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences
  • Knowledge and understanding of cGMP regulations and ICH guidelines preferred
  • Self-awareness, integrity, authenticity, and a growth mindset.

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

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