Automating Quality Control (QC) testing

We are seeking an experienced contractor to support the development, qualification, and implementation of automated QC methods for cell therapy assays. This hands-on role will focus on designing, programming, and optimizing automation scripts and workflows for platforms such as Hamilton and Tecan, ensuring seamless technical transfer and compliance within a GMP environment.

The successful candidate will collaborate with QC, analytical development, and automation teams to drive continuous improvement and operational excellence in automated QC systems.

Key Responsibilities:

• Develop, and qualify automated methods for Cell therapy QC assays (e.g., flow cytometry, cell-based assays, molecular-based assays, and cell viability) using automated liquid handlers and integrated platforms.
• Program and troubleshoot scripts for liquid handlers (e.g., Hamilton) and lab orchestration software (e.g. Cellario).
• Demonstrate that automated assay scripts developed from manual methods are comparable, robust, and fit for intended use through execution of defined development studies.
• Author development reports, work instructions, and supporting technical documentation in compliance with GMP requirements, and support associated validation activities as required.
• Drive troubleshooting and continuous improvement initiatives for automated workflows and systems.
• Drive training sessions and supporting documentation to support hand-off

Required Qualifications:

• Bachelor’s in Life Sciences, Engineering, or related field with 5+ years in analytical, bioanalytical, or automation assay development. Master’s with 3-5 years in the same area. Ph.D. with 1–3 years in the same areas
• 3-5 years of hands-on experience in automation of biologic and Cell Therapy assays.
• Demonstrated proficiency in developing and programming automation scripts for liquid handlers (Hamilton, Tecan, or similar platforms).
• Experience with integrated automation systems and lab orchestration tools (e.g., Cellario, HighRes BioSolutions).
• Strong problem-solving skills and ability to troubleshoot automated workflows and hardware/software issues.
• Familiarity with regulatory requirements for QC in the biopharmaceutical industry and experience supporting audits and inspections.
• Excellent communication and interpersonal skills, with the ability to work collaboratively across multidisciplinary teams.
• Flexibility and eagerness to learn new technologies and techniques.

Preferred Qualifications:

• Experience with programming languages (Python, Visual Basic, etc.) for automation workflows.
• Background in aseptic technique and bioprocess sample handling.
• Experience in analytical method development for cell therapy or biologics.