Senior Associate Data Scientist – Contract

This is a fully remote position, open to applicants in California.

📋 Description

• Contribute to the characterization studies of Cell Starting Material by utilizing Quality by Design (QbD) principles.

• Employ advanced statistical methodologies on extensive and intricate datasets to enhance understanding of raw materials and products.

• Assist in clinical-scale non-GMP manufacturing operations for BLA-enabling process characterization activities.

• Aid in process characterization and ongoing improvement initiatives for CAR-T manufacturing workflows.

• Analyze process parameters, materials, closed or disposable systems, and operational workflows.

• Participate in Project Technical Teams and collaborate effectively with stakeholders.

• Ensure prompt documentation in electronic laboratory notebooks and Technical Reports.

• Contribute to Regulatory Filings and address inquiries from Regulatory bodies.

• Present data and strategic insights to scientists and management.

• Stay updated with literature in cell therapy, immunology, and bioprocessing.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's or Master's degree in Molecular & Cell Biology, Immunology with a focus on data science is preferred.

• Master's degree with a minimum of 2 years of experience, or a Bachelor's degree with at least 5 years of experience.

• Fundamental understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology, and immunology.

• Experience in Quality by Design methodologies and statistical modeling within the biologics or cell therapy sectors is highly desirable.

• Proficiency in multivariate data analysis; familiarity with JMP, R-Studio, and Python is preferred.

• Experience in designing and implementing dashboards for real-time process monitoring.

• Prior experience in flow cytometry is highly preferred.

• Background in Gene & Cell Therapy manufacturing is preferred but not mandatory.

• Familiarity with genetic modification of cells using gene editing and gene delivery technologies is preferred but not required.

• Experience with PBMC isolation techniques is preferred but not required.

• Ability to thrive in a fast-paced, startup environment.

• Strong attention to detail and exceptional multitasking capabilities.

• Excellent organizational and prioritization skills.

• Ability to work independently as well as collaboratively within a team.

• Strong verbal and written communication skills.

• Candidates must be authorized to work in the U.S.

🏝️ Benefits

• One-year contract opportunity with potential for extension or transition to permanent hire.

• Collaborative working environment.

• Opportunity to collaborate with talented individuals.