Job Description

Job Title: Cell Therapy Analytical Development (CTAD)

100% Onsite

Normal Business Hours

Overview: We are seeking an Analytical Method Automation Sr. Associate Scientist to contribute to the development and implementation of Client immunoassays that enable rapid, unsupervised and robust characterization of cell therapy process intermediates during the manufacturing process. This candidate will work closely with lab automation engineers, analytical development and process development scientists to test and implement Client reagents to streamline sample preparation, data acquisition and data analysis workflow. The candidate will also work with the team to transition from manual to automated workflows as development progresses, characterizing method performance and robustness between the two modes. This candidate will support the qualification of the developed automated assay, ensuring method readiness for manufacturing implementation. This role provides a unique opportunity to screen and implement Client assay technologies to support near real-time CAR-T monitoring during manufacturing. A strong background in immunoassays, particularly flow cytometry development, will be needed .

Required Competencies

• Education: Bachelor’s degree in molecular or cellular biology, biomedical engineering, or related discipline

• Experience: 4-5 years of experience in cell-based assay development, specifically cell counting and flow-based assays

• Skills:

o Previous experience with flow cytometry assay development for cell characterization, including panel design and sample preparation protocol development

o Experience with method development and qualification

o Knowledge of flow cytometry reagents and approaches to support automation and streamlining of methods

o Previous experience with in vitro culture of primary cells

Duties and Responsibilities:

Key Responsibilities:

1. Analytical Method Development:

a. Test commercially available reagents for assessment in Client flow cytometry methods.

b. Plan method testing to support thorough screening of sample preparation parameters and their impact on data acquisition/analysis quality

c. Support custom reagent testing and streamlining of analytical method to enable operator-free execution

d. Execute analytical method qualification studies to demonstrate readiness for manufacturing implementation

2. Data Analysis and Reporting

a. Analyze experiment data to identify trends, support decision making and determine next steps

b. Prepare and present data on development progress, analytical method performance across sample types, comparability to existing methods where applicable

c. Author technical documents such as method operating procedures, comparability and qualification protocols and reports.

3. Collaboration and Communication:

a. Communicate effectively with internal stakeholders to ensure alignment and transparency.

b. Work with internal collaborators to support method transfer to other sites

Working Conditions:

• Office and laboratory environment

Physical Demands:

• Sitting for periods of time

Additional Information:

Personal Attributes:

• Highly motivated, detail oriented with the ability to multi-task

• Ability to work independently and as part of a team

• Strong organizational and time management skills

• Strong written, verbal and presentation skills

Additional Job Requirements:

Lab w/ blood & animal

Position Handles Hazardous Materials

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