QC Automation Specialist - Cell Therapy

SOKOL GxP Services is seeking an Automation Specialist to support the development, qualification, and implementation of automated QC methods for cell therapy assays within a GMP-regulated biopharmaceutical environment.

This is a hands-on contractor role focused on designing, programming, troubleshooting, and optimizing automated assay workflows using liquid handling platforms such as Hamilton, Tecan, or similar systems. The Automation Specialist will work closely with QC, Analytical Development, and automation teams to support technical transfer, method qualification, workflow improvements, and compliant documentation for automated QC systems.

Key Responsibilities

• Develop, qualify, and optimize automated methods for cell therapy QC assays, including flow cytometry, cell-based assays, molecular-based assays, cell viability testing, and related biologics assays.
• Program, troubleshoot, and improve automation scripts for liquid handlers such as Hamilton, Tecan, or similar platforms.
• Support integrated automation workflows and lab orchestration systems, including platforms such as Cellario, HighRes BioSolutions, or similar systems.
• Translate manual assay methods into automated workflows and demonstrate comparability, robustness, and fitness for intended use through defined development studies.
• Troubleshoot automated workflows, scripts, instruments, hardware/software issues, and assay execution challenges.
• Author development reports, work instructions, technical documentation, and supporting records in compliance with GMP requirements.
• Support method qualification, technical transfer, validation-related activities, and audit/inspection readiness as needed.
• Collaborate cross-functionally with QC, Analytical Development, automation, validation, and manufacturing support teams.
• Drive continuous improvement initiatives for automated QC systems, assay workflows, and operational efficiency.
• Support training sessions and create documentation to enable successful hand-off of automated methods and workflows.

Requirements:
• Bachelor’s degree in Life Sciences, Engineering, Biotechnology, Biology, Bioengineering, Chemistry, Biochemistry, or a related field with 5+ years of experience in analytical, bioanalytical, or automation assay development.
• Master’s degree with 3–5 years of experience, or Ph.D. with 1–3 years of experience in analytical, bioanalytical, or automation assay development may also be considered.
• 3–5 years of hands-on experience automating biologics and/or cell therapy assays.
• Demonstrated hands-on experience developing, programming, and troubleshooting automation scripts for liquid handlers such as Hamilton, Tecan, or similar platforms.
• Experience with automated QC, analytical, bioanalytical, biologics, or cell therapy assay workflows.
• Experience with integrated automation systems and/or lab orchestration tools such as Cellario, HighRes BioSolutions, or similar platforms.
• Strong troubleshooting skills with the ability to resolve automated workflow, hardware, software, and assay execution issues.
• Familiarity with GMP, QC regulatory expectations, technical documentation, and validation support in a biopharmaceutical environment.
• Ability to support development studies demonstrating automated assay comparability, robustness, and fitness for intended use.
• Strong written and verbal communication skills with the ability to work collaboratively across multidisciplinary teams.
• Flexibility and eagerness to learn new technologies, platforms, and techniques.

Preferred Qualifications

• Experience with programming languages such as Python, Visual Basic, or similar tools used in automation workflows.
• Background in aseptic technique and bioprocess sample handling.
• Experience in analytical method development for cell therapy, biologics, or related therapeutic platforms.
• Experience supporting audits, inspections, validation activities, and GMP documentation.
• Hands-on experience with flow cytometry, cell-based assays, molecular assays, or cell viability assays.

Benefits:
Health insurance, holiday pay, 401(k) program, referral program, and other benefits

Hourly rate, $: 47.03 - 59.74

12-month contract with possible extension

Job Type: On-site

Working hours: Monday - Friday, regular business hours.