Senior Associate Data Scientist – Process Sciences, Contract

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

📋 Description

• Assist the Cell Starting Material–Process Sciences team within Process and Product Development.

• Play a key role in the characterization of cell starting material and the advancement of cell isolation technologies.

• Innovate and execute cutting-edge processing technologies for scalable and resilient manufacturing processes.

• Design and conduct Cell Starting Material characterization studies utilizing QbD principles.

• Utilize advanced statistical tools to analyze large and intricate datasets.

• Aid in clinical-scale non-GMP manufacturing operations for BLA-enabling process characterization initiatives.

• Contribute to process characterization and ongoing improvement efforts for CAR-T manufacturing.

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

• Participate in Project Technical Teams and collaborate with various stakeholder groups.

• Record findings in electronic laboratory notebooks and Technical Reports.

• Assist with regulatory submissions and respond to regulatory inquiries.

• Present data and strategies in technical and Project Team meetings.

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

• Undertake additional responsibilities as assigned.

⛳️ Requirements

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

• MS degree with a minimum of 2 years of relevant experience, or a BS degree with at least 5 years of experience.

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

• Experience with Quality by Design methodologies and statistical modeling in biologics or cell therapy preferred.

• Proficiency in multivariate data analysis.

• Preferred familiarity with JMP, R-Studio, or Python.

• Developed and implemented dashboards for real-time process monitoring.

• Strong preference for experience in flow cytometry.

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

• Experience in 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.

• Capability to thrive in a dynamic startup environment.

• Exceptional attention to detail and the ability to handle multiple tasks simultaneously.

• Strong organizational and prioritization skills.

• Ability to work independently as well as collaboratively in a team setting.

• Excellent verbal and written communication abilities.

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

🏝️ Benefits

• 1-year contract opportunity with potential for extension or contract-to-hire.

• Collaborative work environment.

• An equal opportunity employer dedicated to fostering a diverse workforce.