Job Description

Position Summary

Cellares is seeking an innovative and highly motivated Scientist with broad experience in cell therapy manufacturing, and specific expertise in late-stage process characterization to join the Process Development team. This individual will interface across many parts of the company and play a key role in advancing the reliability and consistency of cell therapy manufacturing processes. This Scientist will drive the design, execution, and analysis of critical experiments aimed at establishing robust manufacturing parameters for client and internal processes. Collaborating closely with cross-functional teams, you will lead efforts to optimize and validate processes that ensure high-quality cell therapy products.

The ideal candidate will be a strong technical contributor and cross-functional collaborator with demonstrated experience developing, characterizing and deploying robust autologous and allogeneic cell therapy processes.

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

Spearhead process characterization studies to identify and establish critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure consistent, high-quality manufacturing outputs

Develop and execute statistically sound experimental designs to evaluate process robustness and scalability, including Design of Experiments (DOE) methodologies

Analyze complex datasets to identify key trends, optimize parameters, and implement data-driven decisions

Collaborate with internal and client-facing manufacturing, MSAT, quality, and regulatory teams to define process requirements and ensure alignment with industry standards and regulatory guidelines

Author and review technical reports, study protocols, and regulatory submissions, providing scientific justification for established parameters and outcomes

Lead cross-functional teams in root cause analysis and troubleshooting to address process inconsistencies, identifying areas for improvement to support continuous process optimization

Provide technical guidance and mentorship to junior team members, fostering a culture of innovation, data integrity, and scientific excellence

Serve as subject matter expert where appropriate for the cell and gene therapy process, provide technical insights and support in troubleshooting and root cause investigations

Requirements

Bachelor's, Master's or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 3-15 years of process development experience in the cell and gene therapy field

Strong expertise in process characterization, Design of Experiments (DOE), and statistical analysis, with a preference for experience using statistical software such as JMP

Familiarity working in a GMP and/or Clinical Manufacturing setting strongly preferred

Experience designing scale-up experiments and troubleshooting semi-automated instruments

Hands-on experience with autologous and/or allogeneic cell therapy manufacturing processes

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

Experience with flow cytometry and cell based assays preferred

Strong understanding of cell biology and immunology

Creative, self-motivated, eager to take on a wide variety of tasks and grow with the evolving technology.

Scientist (I,II,III), Process Characterization - Cellares

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