Position Summary
We are seeking an innovative and highly motivated Associate Scientist in Analytical Development who will contribute to the development of our advanced cell therapy manufacturing platform. The primary focus of this position is development, optimization, automation development, and qualification of various molecular and cell-based analytical methods.
This is a multidisciplinary role as this individual will interface across various departments at the company (process development, quality, software and hardware engineers, automation engineers) on a daily basis. The successful candidate will be well versed in analytical development and automation for cell therapy approaches.
The candidate 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
- Contribute to transfer, development, optimization and pre-qualification of various analytical methods and provide analytical service support
- Perform analytical testing in support of characterization, in-process control, lot release, and stability testing. Provide analytical support for process development and manufacturing operations
- Evaluate/select new technologies, instruments, reagents, and perform necessary qualifications
- Ensure high-quality and timely documentation in laboratory notebook and development reports
- Help in drafting SOPs, test records/forms, various analytical protocols and reports
- Analyze/summarize experimental data and present findings at internal group meetings
- Manage lab reagent inventory and participate in lab maintenance activities as assigned
- Interface with cross functional groups and manage timelines
- Prepare internal and external facing data review slides to present findings
- Work closely with automation engineering to generate user needs for method automation, support in the development and qualification of automated methods
Requirements
- BS or MS in Biochemistry, Molecular Biology, Biology or related subject with 2-6 years of analytical experience in the cell and gene therapy manufacturing field
- Hands-on experience of conducting and analyzing data using methods such as ELISA, qPCR and/or digital PCR, microplate based assays is required
- Hands-on experience in multicolor flow cytometry is highly preferred
- Hands-on experience in mammalian cell tissue culture and cell-based assays is required
- Excellent verbal, written, presentation, and interpersonal skills
- Ability to extract important and relevant information from documents such as SOPs and published articles
- Strong analytical and problem-solving skills
- Creative, self-motivated, and flexible with the desire to work in a startup environment
- Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
- 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.
Top Skills
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.
