Scientist, Analytical Development (I,II,III)

South San Francisco, CA
Process Sciences – Analytical Development /
Full Time /
On-site
Position Summary

We are seeking an innovative, creative, and detail-oriented Scientist to join our team in South San Francisco. This position will work with the Director of Analytical Development to develop assays for cell therapy products from various platforms. Our ideal candidate is a self-motivated individual with a passion for improving current manufacturing practices for cell therapies. Experience in immune cell phenotyping and cell-based assays are important requirements. 

This is a multidisciplinary role & this individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be well versed in analytical development. 

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

Responsibilities

    • Actively contribute to method development, optimization and pre-qualification of various analytical methods and provide analytical service support
    • Plan and execute analytical procedures in support of characterization, lot release, and stability testing of drug substance and drug products
    • Guide and train associates in the team
    • Develop and troubleshoot assays as needed
    • File data and complete experiment report in a timely manner
    • Analyze/summarize experimental data and present findings at both internal and external meetings. Present data at departmental meetings
    • Contribute toward the optimization and improvement of cell therapy manufacturing platforms
    • Assist with laboratory maintenance (cleaning, equipment maintenance, biohazard waste removal)
    • Manage reagent and consumables inventory and ordering as needed

Requirements

    • BS in Biochemistry, Molecular Biology, Biology or related subject with 10-15 years of analytical experience in the cell and gene therapy manufacturing field OR
    • MS in in Biochemistry, Molecular Biology, Biology or related subject with 9-13 years of analytical experience in the cell and gene therapy manufacturing field OR
    • PhD in Biochemistry, Molecular Biology, Biology or related subject with 0-5 years of analytical experience in the cell and gene therapy manufacturing field
    • Extensive experience in immune cells phenotyping by multicolor flow cytometry
    • Extensive experience in cell-based assays, multiplex ELISA or qPCR/ddPCR assays
    • Experience in drafting SOPs and COAs
    • Strong background in cell biology, immunology and molecular biology
    • High attention to detail
    • Comfortable working in a fast-paced environment
    • Self-motivated and passionate about advancing the field of cell therapies
    • Knowledge of Good Laboratory Practices and current Good Manufacturing Practices is a plus
    • 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.