Associate Director, Process Engineering

Celcuity Inc. • Minneapolis, MN

6d

About The Position

Reporting to the Chief Science Officer, the Associate Director, Process Engineering works within a high-complexity, cellular, and molecular testing laboratory to develop processes, procedures, and products from conception to production for clinical test products.

Requirements

• PhD or MS in bioengineering or related field
• Extensive experience leading scientific/engineering teams in complex laboratory environments
• Strong experience in process development and pre-clinical assay development
• Hands-on experience with laboratory process development and scale-up

Responsibilities

• Lead a team of scientists and engineers to develop and optimize processes for complex biochemistry and cell biology laboratory testing
• Work closely with Engineering and R&D teams to implement and maintain quality control of test processes
• Develop molecular assays and define mechanisms of action in complex cell-based systems
• Establish test performance criteria and data quality standards
• Design and execute statistical studies (Design of Experiments, screening designs) to identify key factors in complex assay systems
• Develop and maintain process plans from concept through validation and scale-up
• Support feasibility and development phase reporting
• Create pre-clinical documentation and support regulatory readiness
• Establish and implement maintenance and calibration programs for laboratory equipment in partnership with Facilities
• Support QA/QC programs
• Ensure adherence to safety standards, quality systems, and HIPAA requirements
• Participate in cross-functional meetings and support translational and clinical study initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Manager