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Description

SOKOL GxP Services is seeking a GMP Automation Specialist with direct experience in biopharmaceutical QC environments to support automated assay development for cell therapy programs. This role requires hands-on experience in regulated pharmaceutical laboratories, with a strong understanding of GMP requirements, analytical method development, and automation of biologics assays.

Your responsibilities will include programming and troubleshooting automation systems, conducting system assessments, developing documentation, and providing technical support to ensure operational excellence.

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

Requirements

• Bachelor’s or higher degree in Life Sciences, Biochemistry, Biology, Bioengineering, or related scientific discipline.
• Experience in analytical method development for cell therapy or biologics.
• Minimum 3–5 years of experience in a GMP-regulated pharmaceutical or biotechnology environment
• Direct experience supporting QC laboratory operations for biologics or cell therapy products
• Demonstrated proficiency in developing and programming automation scripts for liquid handlers (Hamilton, Tecan, or similar platforms).
• Hands-on experience with automation of analytical assays within a regulated setting
• Experience supporting validation, method transfer, or audit readiness activities
• 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.
• Excellent communication and interpersonal skills, with the ability to work collaboratively across multidisciplinary teams.
• Flexibility and eagerness to learn new technologies and techniques.
• Experience with programming languages (Python, Visual Basic, etc.) for automation workflows.
• Background in aseptic technique and bioprocess sample handling.

Benefits

• $56.45 - $71.69 an hour
• Health, dental, and vision insurance
• 401(k) plan with company match
• Paid company holidays
• Interest free relocation assistance loan
• Continuous professional development and training opportunities through SOKOL GxP Academy