First Integrated Development and Manufacturing Organization (IDMO) taking an Industry 4.0 approach to mass manufacturing cell therapies.

Cellares, the pioneering Integrated Development and Manufacturing Organization (IDMO), is revolutionizing cell therapy manufacturing with their Industry 4.0 approach. They are seeking a Consumable Qualification Engineer to join their team in South San Francisco. This role is crucial for ensuring the safety and compliance of consumables used in advanced medical and pharmaceutical applications.

The position involves leading testing and validation efforts in compliance with ISO 10993, USP Class VI, and other regulatory standards. You'll work closely with various teams including Systems Engineering, R&D, Mechanical Engineering, Quality, and Manufacturing. The role requires expertise in biocompatibility testing, extractables and leachables analysis, and sterilization validation.

Cellares offers a competitive compensation package ranging from $90,000 to $210,000 annually, along with comprehensive benefits including medical coverage, 401(k) matching, and stock options. The company has raised over $355 million in funding and operates a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.

This is an excellent opportunity for experienced professionals who thrive in a fast-paced, mission-driven environment and want to contribute to advancing cell therapy manufacturing. The role offers the chance to work with cutting-edge technology while making a significant impact on the accessibility of life-saving cell therapies.

Senior Consumable Qualification Engineer role at Cellares, leading testing and validation of consumables for cell therapy manufacturing, offering competitive compensation and benefits.

Consumable Qualification Engineer (I, II, III)

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) taking an Industry 4.0 approach to mass manufacturing cell therapies, developing and operating integrated technologies to accelerate access to life-saving treatments.

Cellares is seeking an innovative and highly motivated Computer System Validation (CSV) Engineer to join their Quality group. This role will significantly contribute to the development of their advanced cell therapy manufacturing platform. The primary focus is to lead Quality Engineering activities in an FDA-regulated environment, ensuring compliance with cGMP, GAMP 5, and ISO 13485 requirements.

Key responsibilities include:
- Providing quality direction and guidance to development and design control processes
- Creating quality documentation, protocols, and reports
- Performing independent reviews of CSV deliverables
- Collaborating with cross-functional teams on design and development activities
- Reviewing documentation for planning, user requirements, risk assessments, and more
- Establishing verification and validation plans
- Driving root cause analysis investigations and CAPAs
- Conducting quality audits

The ideal candidate should have:
- A Bachelor's degree or higher in Science, Engineering, or Software discipline
- 3+ years of experience in Software Quality Engineering and CSV
- Experience in FDA-regulated industries
- Knowledge of Software development life cycles
- Understanding of data integrity requirements
- Practical knowledge of relevant regulations and standards

Cellares offers a competitive compensation package, including base salary, stock options, and comprehensive benefits. The company is headquartered in South San Francisco, California, with a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Backed by world-class investors, Cellares has raised over $355 million in financing.

Join Cellares in their mission to accelerate access to life-saving cell therapies and make a significant impact in the field of cell therapy manufacturing.

Cellares seeks a Computer System Validation Engineer to lead Quality Engineering for their cell therapy manufacturing platform, ensuring FDA compliance and driving innovation.

Computer System Validation Engineer (I, II, III)

Cellares is a company developing advanced cell therapy systems that have never been realized before.

Cellares is seeking an experienced and highly motivated Senior Systems Integration Engineer with expertise in complex instrumentation systems to join the Research and Development team. This individual will interface across many parts of the company and contribute significantly to the development of advanced cell therapy systems that have never been realized before. 

The ideal candidate will have demonstrated experience in biomedical related instruments and consumables development/integration testing activities. As a Systems Integration Engineer, you are expected to learn and adapt to new technologies readily, take ownership of a wide range of tasks, and successfully drive them to completion. You will be required to provide in-depth analysis and help guide important decisions for troubleshooting and continuous improvement projects.

The successful candidate will show proven ability to work and communicate effectively with cross-functional teams, and demonstrate extremely hands-on capability in prior working experiences. 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.

Key responsibilities include:
- On-site technical lead for system characterization, integration, verification testing, troubleshooting, and continuous improvement
- Collaborate with Hardware, Software, Firmware, and Process teams for system bring-up and regression testing
- Design and execute complex experiments using scientific principles and statistical approaches
- Author technical documents, procedures, and reports
- Produce training documentation and provide assistance for the operation team
- Interface with cross-functional teams to drive tasks to completion

Requirements include a degree in Engineering, Bioengineering, Physics, or related field with relevant experience in analytical instrumentation or biotech automation development. Strong analytical and problem-solving skills, excellent communication abilities, and a creative, self-motivated attitude are essential.

Cellares offers a competitive total compensation package, including base salary, highly subsidized health plans, 401(k) matching, free EV charging, onsite lunches, and stock options.

Senior Systems Integration Engineer role at Cellares, developing advanced cell therapy systems with a focus on complex instrumentation and cross-functional collaboration.

Senior Systems Integration Engineer (I,II,III)

Cellares is developing an advanced cell therapy manufacturing platform.

We are seeking an experienced Senior Data Engineer to contribute to developing our advanced cell therapy manufacturing platform. This role will lead the design, development, and management of scalable data pipelines and architecture. The ideal candidate has extensive experience in data engineering, a strong understanding of modern data architectures, and deep knowledge of big data technologies.

Key responsibilities include:
- Architect, design, and implement data pipelines and infrastructure using Azure Cloud Platform and Databricks technologies
- Collaborate with cross-functional teams to develop scalable and efficient data solutions
- Build and maintain data systems using Azure services, ensuring data quality, reliability, and security
- Work with cell therapy process developers, manufacturing operators, and scientists on data preprocessing and preparation
- Implement monitoring and alerting mechanisms for data pipeline performance
- Document processes and provide guidance to team members

Requirements:
- Bachelor's or Master's degree in Computer Science, Engineering, or related field
- At least 6 years of related industry experience
- Expertise in Azure services, data engineering, and cloud environments
- Proficiency in programming languages like Python or C#
- Experience with data visualization tools and data governance practices
- Strong problem-solving skills and ability to work in a fast-paced startup environment

Cellares offers a competitive compensation package, including base salary, stock options, and benefits. This is a full-time, hybrid position located in South San Francisco or Chicago.

Senior Data Engineer role at Cellares, developing advanced cell therapy manufacturing platform using Azure and big data technologies.

Senior Data Engineer (I,II,III)

Cellares is seeking a hands-on Consumable Quality Engineer to lead the testing and validation of consumables in compliance with ISO 10993, USP Class VI, and other relevant regulatory standards. This role works closely with various teams to ensure consumables are safe, compliant, and effective for use in advanced medical and pharmaceutical applications.

Key responsibilities include:
- Developing and leading qualification plans for consumables
- Designing and executing tests for biocompatibility, extractables and leachables, and more
- Coordinating with external labs for test execution
- Collaborating across departments to support consumable integration
- Analyzing test results and producing technical reports
- Presenting findings to stakeholders

Requirements:
- BS/MS in Bioengineering, Chemical Engineering, or Material Science with 10+ years of experience, or PhD with 7+ years
- Deep understanding of biocompatibility standards
- Hands-on experience with qualification testing
- Strong communication skills
- Familiarity with medical device and pharmaceutical industries

Cellares offers a competitive compensation package, including base salary, health benefits, 401(k) matching, and stock options. The company is headquartered in South San Francisco, California, with a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Backed by world-class investors, Cellares has raised over $355 million in financing.

Join Cellares to be part of a mission-driven team working on accelerating access to life-saving cell therapies through innovative manufacturing solutions.

Cellares seeks a Consumable Quality Engineer to lead testing and validation of consumables for cell therapy manufacturing, ensuring regulatory compliance and product safety.

Cellares Engineering Jobs

First Integrated Development and Manufacturing Organization (IDMO) taking an Industry 4.0 approach to mass manufacturing cell therapies.