Supervising Principal Scientist, Process Development

@ Cellares

Supervising Principal Scientist, Process Development

Posted 1 month ago

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

About the job

Cellares, based in SF and NJ, develops advanced cell therapy manufacturing platforms, focusing on automation and scalability for lifesaving therapies.

Requirements

6-20 years process development experience
Expertise in T cell, HSC, iPSC therapies
Experience with cell processing instruments
Knowledge of cell editing technologies
Strong communication skills

Qualifications

Bachelor's, Master's, or PhD degree
Experience in cell therapy field
Understanding of cGMP and ICH guidelines
Leadership and collaboration skills
Enthusiastic with growth mindset

Full job description

Position Summary

We are seeking an innovative and highly motivated Supervising Principal Scientist with expertise in cell therapy process development and people management. This individual will interface across many parts of the organization and contribute significantly to the development of our advanced cell therapy manufacturing platform.

The primary focus of this position is to provide organizational leadership and technical insight into the onboarding and optimization of new cell therapy processes to expand and drive continuous improvement of the Cellares platform. The ideal candidate will be an adept leader and cross-functional collaborator with demonstrated expertise in developing robust autologous and allogeneic cell therapy processes. The role requires close collaboration internally and with external partners.

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

Lead multifaceted process development efforts to drive continuous improvement of the Cellares platform.

Interface directly with external partners to facilitate technology transfer, data reviews, and overall program governance.

Develop and manage program timelines for process development.

Perform gap assessments and develop thorough development plans, statements of work, test plans, protocols, and any other applicable documents.

Coordinate day-to-day team efforts by managing, mentoring and providing technical training to junior team members.

Prepare and present technical and organizational updates and forward-thinking proposals to Technical Operations leadership.

Lead technology transfer efforts to implement new processes and technologies in collaboration with Analytical Development, MSAT, Quality, Manufacturing, Alliance Management and Engineering.

Evaluate and recommend new technologies for benchmark testing with Cellares instruments.

Author and review technical documents, procedures, reports and presentations to ensure accuracy and quality.

Requirements

Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-20 years of process development experience in the cell and gene therapy field

Subject-matter expert in T cell, HSC, iPSC or other immune cell therapy modalities

Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave)

Familiarity with diverse cell editing and payload delivery technologies (LVV, RVV, LNP, CRISPR, TALENs, ZFNs, 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, enthusiasm 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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