Scientist, Analytical Development (I,II,III)

Posted 16 Days Ago
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South San Francisco, CA
Senior level
Biotech
The Role
The Scientist in Analytical Development will develop and optimize assays for cell therapy products, execute analytical procedures for drug characterization and stability testing, guide fellow team members, and contribute to cell therapy manufacturing improvements.
Summary Generated by Built In

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.


The Company
HQ: South San Francisco, CA
109 Employees
On-site Workplace
Year Founded: 2019

What We Do

Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.

The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.

Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.

The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.

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